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Injection related anxiety in insulin-treated diabetes
Diabetes Research and Clinical Practice 46 (1999) 239 – 246 www.elsevier.com/locate/diabres
Injection related anxiety in insulin-treated diabetes Andrew Zambanini a,*, Roger B. Newson b, Mari Maisey c, Michael D. Feher a,c a
Section of Clinical Pharmacology, Imperial College School of Medicine, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK b Department of Public Health, Imperial College School of Medicine, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK c Beta Cell Diabetes Centre, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK Received 18 March 1999; received in revised form 25 May 1999; accepted 9 August 1999
Abstract The presence of injection related anxiety and phobia may influence compliance, glycaemic control and quality of life in patients with insulin-treated diabetes. Unselected consecutive, insulin-treated patients attending a diabetes clinic for follow-up, completed a standardised questionnaire providing an injection anxiety score (IAS) and general anxiety score (GAS). A total of 115 insulin-treated (80 Type 1 and 35 Type 2) diabetic patients completed the questionnaire. Injections had been avoided secondary to anxiety in 14% of cases and 42% expressed concern at having to inject more frequently. An IAS]3 was seen in 28% of patients and of these, 66% injected insulin one to two times/day, 45% had avoided injections, and 70% would be bothered by more frequent injections. A significant correlation between IAS and GAS was seen (Kendall’s tau-a 0.30, 95% CI 0.19– 0.41, PB 0.001). GAS was significantly associated with both previous injection avoidance and expressed concern at increased injection frequency. No significant correlation was seen with HbA1c and injection or general anxiety scores. Symptoms relating to insulin injection anxiety and phobia have a high prevalence in an unselected group of diabetic patients requiring insulin injections and are associated with higher levels of general anxiety. © 1999 Published by Elsevier Science Ireland Ltd. All rights reserved. Keywords: Diabetes; Insulin; Injection; Phobia; Anxiety
1. Introduction Psychological and behavioural factors are important determinants in the successful management of several chronic conditions including * Corresponding author. Tel.: + 44-181-7468144; fax: +44181-7468887. E-mail address: [email protected] (A. Zambanini)
insulin-treated diabetes. The presence of injectionrelated anxiety and phobia may be particularly relevant for diabetic patients treated with insulin. There are few studies however, which have assessed either the extent of this problem or ascertained the influence of these disorders on glycaemic control in patients attending the diabetes clinic. Limited information on this aspect of management has focused on the fear of blood and
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injury and the associated poor glycaemic control in Type 1 diabetic adults [1]. There has also been published a single case report, describing the features of a patient with over three decades of documented needle- and injection-related phobia [2]. The aims of this study were first, to ascertain the prevalence of phobia and anxiety symptoms related to insulin injection, second to assess the association between insulin injection anxiety symptoms with the level of general anxiety in the study group, and third to evaluate the influence of these factors on glycaemic control.
2. Materials and methods
2.1. Patients A questionnaire survey was performed of consecutive insulin-treated patients with either Type 1 or Type 2 diabetes, attending a teaching hospital diabetes outpatient clinic, for routine follow-up. The study was conducted over a single 3-month period. Patients were excluded from the study if daily insulin injections had been performed for less than 1 month. Those who were eligible to participate were invited to complete a questionnaire at the end of the consultation with either a doctor or diabetes specialist nurse. All patients were aged over 18 years, able to give verbal consent and able to complete the questionnaire either unaided or with the help of an interpreter. Ethics approval for this study was obtained from the Riverside Ethics Approval Committee.
the answers given (Appendix A). The seven key questions were derived from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnostic criteria for 300.29 specific phobia [3]. The subjects’ answers were scored from 0 to 3 for both feelings regarding daily injection and feelings during injection (i.e. 0 for ‘unconcerned’ and 3 for ‘fear’). In addition, the presence of reported symptoms compatible with a panic attack scored 1 point for each symptom with a maximum score of 4 points attainable. The other four questions scored 1 point each, for an affirmative answer. For IAS, a minimum score of 0 and a maximum score of 14 were possible. The third part of the questionnaire (Appendix A) was derived directly from the Hospital Anxiety and Depression Scale; this has a well described scoring system, has been validated as a screening tool for depression and anxiety [4], and has also been used specifically in patients with Type 1 and Type 2 diabetes [5–8]. In this study, in order to assess general anxiety, the anxiety subscale from the Hospital Anxiety and Depression Scale was utilised. A general anxiety score (GAS) was derived from these answers. Glycaemic control was determined by the measurement of glycated haemoglobin (HbA1c) by HPLC (Biorad DIAMAT, Hercules, USA) which was measured on the day of the survey. The range for non-diabetic subjects in our hospital is 4.3–6.1%.
3.1. Statistical analysis 3. Measurements
The questionnaire consisted of three sections: Registration data including age, sex, duration of diabetes, duration of insulin use, number of daily injections and insulin injecting device. The second part of the questionnaire ascertained details regarding the presence of symptoms associated with possible anxiety or phobia related to insulin injections and an injection anxiety score (IAS) was derived from
Student’s unpaired t-test was used for the comparison of continuously distributed variables and Wilcoxon’s test was used for ordered variables. The chi-squared test was used to assess for differences in frequency distributions. Kendall’s tau-a for rank correlation, was used to test the relationship between continuous variables such as injection anxiety and general anxiety scores, and HbA1c, age, duration of diabetes, duration of insulin use and number of daily injections.
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
Somers’ D [8] was used to measure how injection anxiety score was associated with binary variables such as gender, type of diabetes and the use of pen or syringe for injections. It was also used to estimate how well general anxiety score was associated with gender, type of diabetes, the use of pen or syringe for injections, previous avoidance of injection, and expressed concern at having to inject more frequently. Poisson regression analysis with robust standard errors, was used to derive confidence intervals for the ratio of both mean injection and general anxiety scores between men and women, injection avoiders/non-avoiders, and patients with expressed anxiety/no expressed anxiety regarding additional injections. Patients were divided into two groups of general anxiety score (GAS), those with a general anxiety score measuring 8 or greater (GAS] 8) and those scoring less than 8 (GASB 8). Comparisons were made within the GAS groups with regards to age, sex, duration of diabetes, duration of insulin use, use of pen and/or syringe, number of injections, HbA1c, the avoidance of injections, being bothered by injections and injection anxiety score.
241
4. Results A total of 116 insulin-treated patients were surveyed over the study period. Complete questionnaires were obtained from 115 (59 female and 56 male) subjects. The majority of subjects (n = 80) had Type 1 diabetes, while the remainder (n= 35) had insulin treatment for Type 2 diabetes. In 11 cases no suitable HbA1c result was available. Clinical details are given in Table 1. 4.1. Type 1 and Type 2 diabetes Patients with Type 1 diabetes mellitus were most likely to inject four times per day as compared with Type 2 diabetic patients who mainly injected twice a day (Table 1). The study group had a mean (S.D.) HbA1c of 9.0 (1.8)%. No significant difference in HbA1c was noted for patients with Type 1 diabetes (8.8 (1.7)%) compared with Type 2 diabetic patients (9.5 (1.9)%). The type of diabetes failed to significantly predict injection anxiety score (Somers’ D 0.01 (95% CI −0.22–0.23)) or general anxiety score (Somers’ D − 0.12 (95% CI − 0.35–0.11)). When men and women were compared, there was no significant difference in the relationship between the type of diabetes and GAS or IAS.
Table 1 Clinical data and insulin regimens for the insulin-treated patients studieda All patients Patients Men/women Age (years) Duration of diabetes (years) Duration of insulin use (years) Pen injection device Syringe Injections/day 1 2 3 4 5 a
115 56/59 (49/51) 42 (31–61)b 15 (6–23)b 10 (3–21)b 80 (70) 54 (47) 9 50 6 48 2
(8) (43) (5) (42) (2)
Number (%) or mean9S.D. unless otherwise indicated. Median (inter-quartile range). * PB0.001, Type 1 versus Type 2 diabetic patients.
b
Type 1 diabetes 80 41/39 (51/49) 38.5 9 13.7 16.4 9 14.2 16.3 9 14.2 54 (68) 39 (49) 6 (8) 24(30) 5 (6) 44 (55) 1 (1)
Type 2 diabetes 35 15/20 (43/57)* 62.1 9 11.8* 15.9 98.7 6.4 95.8* 26 (74) 15 (43) 3 26 1 4 1
(9) (74)* (3) (11)* (3)
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Table 2 Responses to questions relating to insulin injections, injection anxiety and general anxiety scoresa
Avoid injections secondary to anxiety Troubled by more injections IAS 0–2 IAS 3–9 IAS 10–14 GAS 0–7 GAS]8 a
All patients
Type 1 diabetes
Type 2 diabetes
16 48 82 29 4 86 29
11 38 59 18 3 58 22
5 10 23 11 1 28 7
(14) (42) (72) (25) (3) (75) (25)
(14) (48) (73) (23) (4) (73) (27)
(14) (29) (66) (31) (3) (80) (20)
Number (%), GAS, general anxiety score; IAS, injection anxiety score.
Table 3 Correlation (Kendall’s tau-a) between injection anxiety score (IAS), general anxiety score (GAS) and measured variablesa IAS
GAS value
tau-a Injection anxiety score Number of insulin injections HbA1c Age Duration of diabetes Duration of insulin use a
− 0.17 0.08 0.03 −0.04 −0.08
Not applicable (−0.27− 0.07) (−0.04–0.21) (−0.08–0.15) (−0.15–0.08) (−0.26–0.10)
P-value
tau-a
P-value
0.001 NS NS NS NS
0.30 (0.19–0.41) −0.03 (−0.16–0.09) 0.10 (−0.04–0.23) −0.06 (−0.17–0.05) −0.08 (−0.20–0.03) −0.04 (−0.22–0.15)
B0.001 NS NS NS NS NS
Kendall’s tau-a (95% CI).
4.2. Injection anxiety scores (IAS) The distribution of scores relating to the insulin injection part of the questionnaire, is shown in Table 2. A total of 82 patients (72%) had an IAS of less than 3 points and four had a score ] 10 points. On dividing the group into those with high ( ] 3) and low (B 3) injection anxiety scores, significant differences were noted. Once or twice daily injections were performed in 22 patients (66%) with a high IAS compared with 37 patients (45%) with a low IAS (P B0.05). Of those subjects who had previously avoided insulin injections, only one patient had a low IAS compared with 15 patients (45%), who had a high IAS (P B 0.001). Less than a third (n =25) of those with a low IAS expressed concern at having to inject more frequently, compared with nearly 3/4 (n = 23) of patients with a high IAS (P B 0.001). The median GAS in the IAS]3 group, was 7
points as compared with the IASB 3 group, where the median GAS was 3 points (PB 0.001). There was a significant negative correlation between IAS and the number of daily insulin injections (Table 3). However, there was no significant correlation between IAS and HbA1c, age, the duration of diabetes or the duration of insulin use. There was no predictive association between gender or the use of syringe/pen, and IAS (Table 4). 4.3. General anxiety scores (GAS) The degree of glycaemic control as assessed by the HbA1c in subjects with high versus low general anxiety scores (GAS] 8 and GASB8) was not significantly different (mean HbA1c (S.D.), 9.3 (2.0) vs. 8.9 (1.7)%). Nor was there a significant correlation between HbA1c and GAS (Table 3). The median IAS was 1 point in the GASB 8 group and 3 points in the GAS ] 8 group (PB 0.001). A significant correlation was also found between IAS and GAS (Table 3).
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
Equal numbers of patients who had avoided injections were seen in the high and low general anxiety groups. However the proportion of patients avoiding injections in the high general anxiety group was significantly greater (28%) compared with the low general anxiety group (9%) (P B0.05). GAS was significantly predicted by previous injection avoidance as seen in Table 4. Poisson regression analysis also showed that the mean GAS for injection avoiders was almost twice that for non-avoiders (mean GAS ratio 1.96 (95% CI 1.44–2.66), P B0.001). A total of 30 patients (35%) in the GASB 8 group and 18 patients (62%) in the GAS] 8 group expressed concern at having to inject more frequently (P B 0.01). GAS was significantly predicted by expressed concern at increased injection frequency (Table 4). Poisson regression analysis also showed that the mean GAS was significantly higher for patients expressing concern at having to inject more frequently than for those who did not (mean GAS ratio 1.62 (95% CI 1.21 – 2.19), P= 0.001). Age, duration of diabetes, duration of insulin use and the number of daily injections were not significantly correlated with GAS (Table 3). GAS was also not significantly predicted by gender or by the use of pen or syringe (Table 4).
5. Discussion The most important finding from this study is that a considerable number of patients (approximately a quarter) have a psychological problem
243
with injecting insulin, associated with a high injection anxiety or general anxiety score. This may be clinically relevant as compliance and treatment flexibility are essential factors in achieving optimal glycaemic control. We have also shown that patients who have previously avoided insulin injections or who express concern at having to inject more frequently, have higher general anxiety scores. This would suggest that in these patients, injection anxiety may be part of a more generalised psychological disorder. Furthermore, our use of the anxiety subscale from the Hospital Anxiety and Depression Scale may not differentiate adequately between anxiety, depression and other psychiatric disorders. Those four patients with very high injection anxiety scores (i.e. IAS] 10), may have had a distinct injection phobia, an important and perhaps underdiagnosed condition. However this study was not designed specifically to diagnose this disorder as the questionnaire acts as a descriptive tool designed to identify patients with symptoms which may be related to injection phobia or anxiety. Our study did not show any significant correlations between injection or general anxiety and gender, age, the duration of diabetes, or the duration of insulin use. Women appeared to have higher general anxiety scores than men, a finding consistent with other studies [9,10], but the study was not powerful enough for the difference in GAS to be statistically significant. Furthermore our group was generally older, with long-standing diabetes.
Table 4 Association (Somers’ D) of measured variables and injection anxiety score (IAS) and general anxiety score (GAS)a Variable
IAS
GAS
Somers’ D Previous injection avoidance Concern at increased injection frequency Female gender Use of pen Use of syringe a
Somers’ D (95% CI).
Not Not 0.05 0.15 0.06
applicable applicable (−0.15–0.26) (−0.41–0.11) (−0.35–0.22)
P-value
Somers’ D
P-value
NS NS NS
0.55 (0.29–0.81) 0.41 (0.21–0.60) 0.14 (−0.08–0.36) 0.06 (−0.21–0.32) −0.12 (−0.35–0.11)
PB0.001 PB0.001 NS NS NS
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The relationship between assessed psychological parameters and glycaemic control may have important therapeutic implications. In the study by Berlin at al. [1], poor glycaemic control in patients with Type 1 diabetes was associated with higher levels of anxiety-depression and phobic symptoms. In addition they showed that such patients performed fewer blood glucose measurements per day. One further study showed that co-existent psychiatric illness was associated with a higher observed HbA1c (10.8%) as compared with those never psychiatrically ill where the mean HbA1c was 9.6% (P= 0.02) [10]. Although our study did not show a significant difference in HbA1c between the higher and lower scoring injection and general anxiety groups, the mean HbA1c concentration was higher in those with higher injection anxiety scores. Diabetic patients (both Type 1 and Type 2) with anxiety related to insulin injections, may develop their symptoms either before or soon after they are given the diagnosis of diabetes. Ost [11] suggested that injection phobia is frequently acquired in childhood as a result of negative conditioning. However others have suggested that initial anxiety over injections does not invariably result in a poor long-term outcome [12]. In that study, children whose mothers had a low level of general distress at baseline, had better metabolic control in the long-term. Needle phobia or injection-related anxiety are not the only psychological factors which may affect compliance with insulin treatment. White et al. [13] identified patients who had a passive dependent approach to diabetes, as having worse glycaemic control. In addition, aggressive glycaemic control increases the risk of hypoglycaemia [14], and this complication of treatment may increase anxiety and fear in some patients. The education of patients and their families together with the evaluation of existing knowledge regarding hypoglycaemia, is essential for self-care and may improve compliance [15]. Older patients with Type 2 diabetes may provide a therapeutic dilemma distinct from the problems seen in patients with Type 1 diabetes. These patients may be treated with combinations of oral hypoglycaemic agents and may initially resist the
need for insulin therapy. Interestingly a study by Hunt et al. [16], showed that patients with Type 2 diabetes clearly understood the benefits of insulin use. However they did have concerns regarding pain from injection, hypoglycaemia, proper injection technique and the potential for insulin to cause health problems. These results would therefore suggest that health professionals should avoid negatively emphasising such concepts and should address these questions in a positive and reassuring manner. We believe that the results of this study have highlighted the role of an insulin injection anxiety questionnaire. It has the potential for the diabetes care team to identify patients who may be having psychological problems with their insulin treatment. However further psychological evaluation would be required in order to define concurrent disorders which may be associated with insulin injection anxiety. The identification of such disorders would facilitate the focus of appropriate physical and psychological treatments. Injectionrelated and general anxiety are common in patients attending a hospital-based diabetes clinic. The identification of patients with injection-related phobia and anxiety [2], as well as those with other psychiatric disorders, is an important aspect towards helping these patients take control of their diabetes management.
Appendix A. Insulin Treatment Questionnaire
HbA1c……… Male/Female Age……… How long have you had diabetes? ……years. Do you use: Pen device Yes No How long have you injected insulin? ……years. Syringe Yes No Number of injections per day? 1 2 3 4 5 other…… How would you describe your feeling regarding daily injections? Unconcerned Mild anxiety Moderate anxiety Fear Are these feelings excessive or Yes No unreasonable?
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
Have you ever avoided injecYes tions because of these feelings?
No
When you are injecting, how would you describe your feelings? Unconcerned Mild anxiety Moderate anxiety Fear If you had to inject insulin more frequently would this trouble you? Does your feeling about injections interfere with your daily life?
Yes
No
Yes
No
Have you developed any of the before an injection? Palpitations/ Pounding heart Sweating Trembling or shaking Feeling short of breath or smothered Feeling of choking Chest pain or discomfort Nausea or ‘tummy pains’ Dizziness/unsteady/light-headed or faint Feelings of being detached from yourself or unreal Fear of losing control or going crazy Fear of dying Numbness or tingling sensations Chills or hot flushes
following Yes Yes Yes Yes
No No No No
Yes Yes Yes Yes
No No No No
Yes
No
Yes
No
Yes Yes Yes
No No No
245
Worrying thoughts go through my mind: A great deal of the time
A lot of the time
From time to time but not
too often Only occasionally
I can sit at ease and feel relaxed: Definitely Usually Not often Not at all
I get a sort of frightened feeling like ‘butterflies’ in the stomach: Not at all Occasionally Quite often Very often
I feel restless as if I have to be on the move Very much indeed
Quite a lot
Not very much
Not at all
I get sudden feelings of panic: Very often indeed Quite often Not very often Not at all
Please tick one box only: I feel tense or ‘wound up’ Most of the time A lot of the time Occasionally Not at all
References
I get a sort of frightened feeling as if something awful is about to happen: Very definitely and quite badly
Yes, but not too badly
A little, but it doesn’t worry me
Not at all
[1] I. Berlin, J.C. Bisserbe, E. Renate, et al., Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycaemic control in Type 1 diabetic adults, Diabetes Care 20 (1997) 176 – 178. [2] A. Zambanini, M.D. Feher, Needle phobia in Type 1 diabetes mellitus, Diabetic Med. 14 (1997) 321 – 323. [3] American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed, American Psychiatric Association, Washington, DC, 1994, pp. 405 – 411. [4] A.S. Zigmond, R.P. Snaith, The Hospital Anxiety and Depression Scale, Acta Psychiatr. Scand. 67 (1983) 361 – 370.
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[5] K. Meadows, N. Steen, E. McColl, et al., The Diabetes Health Profile (DHP): a new instrument for assessing the psychosocial profile of insulin requiring patients — development and psychometric evaluation, Qual. Life. Res. 5 (1996) 242 – 254. [6] A.L. Carrington, S.K. Mawdsley, M. Morley, J. Kincey, A.J. Boulton, Psychological status of diabetic people with or without limb disability, Diabetes Res. Clin. Pract. 32 (1996) 19 – 25. [7] K.S. Akinlade, J.U. Ohaeri, M.A. Suberu, The psychological condition of a cohort of Nigerian diabetic subjects, Afr. J. Med. Med. Sci. 25 (1996) 61–67. [8] R.H. Somers, A new asymmetric measure of association for ordinal variables, Am. Sociol. Rev. 21 (1962) 799– 811. [9] M. Peyrot, Levels and risks of depression and anxiety symptomatology among diabetic adults, Diabetes Care 20 (1997) 585 – 590. [10] P.J. Lustman, L.S. Griffith, R.E. Clouse, P.E. Cryer, Psychiatric illness in diabetes: relationship to symptoms and glucose control, J. Nerv. Ment. Dis. 174 (1986) 736 – 749.
[11] L.G. Ost, Acquisition of blood and injection phobia and anxiety response patterns in clinical patients, Behav. Res. Ther. 29 (1991) 323 – 332. [12] G. Thernlund, G. Dahlquist, B. Hagglof, et al., Psychological reactions at the onset of insulin-dependent diabetes mellitus in children and later adjustment and metabolic control, Acta Pediatr. 85 (1996) 947 – 953. [13] R. White, P. Tata, T. Burns, Mood, learned resourcefulness and perceptions of control in Type 1 diabetes mellitus, J. Psychosom. Res. 40 (1996) 205 – 212. [14] The Diabetes Control and Complications Trial Research Group, The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, N. Engl. J. Med. 329 (1993) 977 – 986. [15] J.A. Drass, R.H. Feldman, Knowledge about hypoglycaemia in young women with Type 1 diabetes and their supportive others, Diabetes Educ. 22 (1996) 34 – 38. [16] L.M. Hunt, M.A. Valenzuela, J.A. Pugh, NIDDM patients’ fears and hopes about insulin therapy. The basis of patient reluctance, Diabetes Care 20 (1997) 292 – 298.
.
Injection related anxiety in insulin-treated diabetes Andrew Zambanini a,*, Roger B. Newson b, Mari Maisey c, Michael D. Feher a,c a
Section of Clinical Pharmacology, Imperial College School of Medicine, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK b Department of Public Health, Imperial College School of Medicine, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK c Beta Cell Diabetes Centre, Chelsea & Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK Received 18 March 1999; received in revised form 25 May 1999; accepted 9 August 1999
Abstract The presence of injection related anxiety and phobia may influence compliance, glycaemic control and quality of life in patients with insulin-treated diabetes. Unselected consecutive, insulin-treated patients attending a diabetes clinic for follow-up, completed a standardised questionnaire providing an injection anxiety score (IAS) and general anxiety score (GAS). A total of 115 insulin-treated (80 Type 1 and 35 Type 2) diabetic patients completed the questionnaire. Injections had been avoided secondary to anxiety in 14% of cases and 42% expressed concern at having to inject more frequently. An IAS]3 was seen in 28% of patients and of these, 66% injected insulin one to two times/day, 45% had avoided injections, and 70% would be bothered by more frequent injections. A significant correlation between IAS and GAS was seen (Kendall’s tau-a 0.30, 95% CI 0.19– 0.41, PB 0.001). GAS was significantly associated with both previous injection avoidance and expressed concern at increased injection frequency. No significant correlation was seen with HbA1c and injection or general anxiety scores. Symptoms relating to insulin injection anxiety and phobia have a high prevalence in an unselected group of diabetic patients requiring insulin injections and are associated with higher levels of general anxiety. © 1999 Published by Elsevier Science Ireland Ltd. All rights reserved. Keywords: Diabetes; Insulin; Injection; Phobia; Anxiety
1. Introduction Psychological and behavioural factors are important determinants in the successful management of several chronic conditions including * Corresponding author. Tel.: + 44-181-7468144; fax: +44181-7468887. E-mail address: [email protected] (A. Zambanini)
insulin-treated diabetes. The presence of injectionrelated anxiety and phobia may be particularly relevant for diabetic patients treated with insulin. There are few studies however, which have assessed either the extent of this problem or ascertained the influence of these disorders on glycaemic control in patients attending the diabetes clinic. Limited information on this aspect of management has focused on the fear of blood and
0168-8227/99/$ - see front matter © 1999 Published by Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 8 - 8 2 2 7 ( 9 9 ) 0 0 0 9 9 - 6
240
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
injury and the associated poor glycaemic control in Type 1 diabetic adults [1]. There has also been published a single case report, describing the features of a patient with over three decades of documented needle- and injection-related phobia [2]. The aims of this study were first, to ascertain the prevalence of phobia and anxiety symptoms related to insulin injection, second to assess the association between insulin injection anxiety symptoms with the level of general anxiety in the study group, and third to evaluate the influence of these factors on glycaemic control.
2. Materials and methods
2.1. Patients A questionnaire survey was performed of consecutive insulin-treated patients with either Type 1 or Type 2 diabetes, attending a teaching hospital diabetes outpatient clinic, for routine follow-up. The study was conducted over a single 3-month period. Patients were excluded from the study if daily insulin injections had been performed for less than 1 month. Those who were eligible to participate were invited to complete a questionnaire at the end of the consultation with either a doctor or diabetes specialist nurse. All patients were aged over 18 years, able to give verbal consent and able to complete the questionnaire either unaided or with the help of an interpreter. Ethics approval for this study was obtained from the Riverside Ethics Approval Committee.
the answers given (Appendix A). The seven key questions were derived from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnostic criteria for 300.29 specific phobia [3]. The subjects’ answers were scored from 0 to 3 for both feelings regarding daily injection and feelings during injection (i.e. 0 for ‘unconcerned’ and 3 for ‘fear’). In addition, the presence of reported symptoms compatible with a panic attack scored 1 point for each symptom with a maximum score of 4 points attainable. The other four questions scored 1 point each, for an affirmative answer. For IAS, a minimum score of 0 and a maximum score of 14 were possible. The third part of the questionnaire (Appendix A) was derived directly from the Hospital Anxiety and Depression Scale; this has a well described scoring system, has been validated as a screening tool for depression and anxiety [4], and has also been used specifically in patients with Type 1 and Type 2 diabetes [5–8]. In this study, in order to assess general anxiety, the anxiety subscale from the Hospital Anxiety and Depression Scale was utilised. A general anxiety score (GAS) was derived from these answers. Glycaemic control was determined by the measurement of glycated haemoglobin (HbA1c) by HPLC (Biorad DIAMAT, Hercules, USA) which was measured on the day of the survey. The range for non-diabetic subjects in our hospital is 4.3–6.1%.
3.1. Statistical analysis 3. Measurements
The questionnaire consisted of three sections: Registration data including age, sex, duration of diabetes, duration of insulin use, number of daily injections and insulin injecting device. The second part of the questionnaire ascertained details regarding the presence of symptoms associated with possible anxiety or phobia related to insulin injections and an injection anxiety score (IAS) was derived from
Student’s unpaired t-test was used for the comparison of continuously distributed variables and Wilcoxon’s test was used for ordered variables. The chi-squared test was used to assess for differences in frequency distributions. Kendall’s tau-a for rank correlation, was used to test the relationship between continuous variables such as injection anxiety and general anxiety scores, and HbA1c, age, duration of diabetes, duration of insulin use and number of daily injections.
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
Somers’ D [8] was used to measure how injection anxiety score was associated with binary variables such as gender, type of diabetes and the use of pen or syringe for injections. It was also used to estimate how well general anxiety score was associated with gender, type of diabetes, the use of pen or syringe for injections, previous avoidance of injection, and expressed concern at having to inject more frequently. Poisson regression analysis with robust standard errors, was used to derive confidence intervals for the ratio of both mean injection and general anxiety scores between men and women, injection avoiders/non-avoiders, and patients with expressed anxiety/no expressed anxiety regarding additional injections. Patients were divided into two groups of general anxiety score (GAS), those with a general anxiety score measuring 8 or greater (GAS] 8) and those scoring less than 8 (GASB 8). Comparisons were made within the GAS groups with regards to age, sex, duration of diabetes, duration of insulin use, use of pen and/or syringe, number of injections, HbA1c, the avoidance of injections, being bothered by injections and injection anxiety score.
241
4. Results A total of 116 insulin-treated patients were surveyed over the study period. Complete questionnaires were obtained from 115 (59 female and 56 male) subjects. The majority of subjects (n = 80) had Type 1 diabetes, while the remainder (n= 35) had insulin treatment for Type 2 diabetes. In 11 cases no suitable HbA1c result was available. Clinical details are given in Table 1. 4.1. Type 1 and Type 2 diabetes Patients with Type 1 diabetes mellitus were most likely to inject four times per day as compared with Type 2 diabetic patients who mainly injected twice a day (Table 1). The study group had a mean (S.D.) HbA1c of 9.0 (1.8)%. No significant difference in HbA1c was noted for patients with Type 1 diabetes (8.8 (1.7)%) compared with Type 2 diabetic patients (9.5 (1.9)%). The type of diabetes failed to significantly predict injection anxiety score (Somers’ D 0.01 (95% CI −0.22–0.23)) or general anxiety score (Somers’ D − 0.12 (95% CI − 0.35–0.11)). When men and women were compared, there was no significant difference in the relationship between the type of diabetes and GAS or IAS.
Table 1 Clinical data and insulin regimens for the insulin-treated patients studieda All patients Patients Men/women Age (years) Duration of diabetes (years) Duration of insulin use (years) Pen injection device Syringe Injections/day 1 2 3 4 5 a
115 56/59 (49/51) 42 (31–61)b 15 (6–23)b 10 (3–21)b 80 (70) 54 (47) 9 50 6 48 2
(8) (43) (5) (42) (2)
Number (%) or mean9S.D. unless otherwise indicated. Median (inter-quartile range). * PB0.001, Type 1 versus Type 2 diabetic patients.
b
Type 1 diabetes 80 41/39 (51/49) 38.5 9 13.7 16.4 9 14.2 16.3 9 14.2 54 (68) 39 (49) 6 (8) 24(30) 5 (6) 44 (55) 1 (1)
Type 2 diabetes 35 15/20 (43/57)* 62.1 9 11.8* 15.9 98.7 6.4 95.8* 26 (74) 15 (43) 3 26 1 4 1
(9) (74)* (3) (11)* (3)
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Table 2 Responses to questions relating to insulin injections, injection anxiety and general anxiety scoresa
Avoid injections secondary to anxiety Troubled by more injections IAS 0–2 IAS 3–9 IAS 10–14 GAS 0–7 GAS]8 a
All patients
Type 1 diabetes
Type 2 diabetes
16 48 82 29 4 86 29
11 38 59 18 3 58 22
5 10 23 11 1 28 7
(14) (42) (72) (25) (3) (75) (25)
(14) (48) (73) (23) (4) (73) (27)
(14) (29) (66) (31) (3) (80) (20)
Number (%), GAS, general anxiety score; IAS, injection anxiety score.
Table 3 Correlation (Kendall’s tau-a) between injection anxiety score (IAS), general anxiety score (GAS) and measured variablesa IAS
GAS value
tau-a Injection anxiety score Number of insulin injections HbA1c Age Duration of diabetes Duration of insulin use a
− 0.17 0.08 0.03 −0.04 −0.08
Not applicable (−0.27− 0.07) (−0.04–0.21) (−0.08–0.15) (−0.15–0.08) (−0.26–0.10)
P-value
tau-a
P-value
0.001 NS NS NS NS
0.30 (0.19–0.41) −0.03 (−0.16–0.09) 0.10 (−0.04–0.23) −0.06 (−0.17–0.05) −0.08 (−0.20–0.03) −0.04 (−0.22–0.15)
B0.001 NS NS NS NS NS
Kendall’s tau-a (95% CI).
4.2. Injection anxiety scores (IAS) The distribution of scores relating to the insulin injection part of the questionnaire, is shown in Table 2. A total of 82 patients (72%) had an IAS of less than 3 points and four had a score ] 10 points. On dividing the group into those with high ( ] 3) and low (B 3) injection anxiety scores, significant differences were noted. Once or twice daily injections were performed in 22 patients (66%) with a high IAS compared with 37 patients (45%) with a low IAS (P B0.05). Of those subjects who had previously avoided insulin injections, only one patient had a low IAS compared with 15 patients (45%), who had a high IAS (P B 0.001). Less than a third (n =25) of those with a low IAS expressed concern at having to inject more frequently, compared with nearly 3/4 (n = 23) of patients with a high IAS (P B 0.001). The median GAS in the IAS]3 group, was 7
points as compared with the IASB 3 group, where the median GAS was 3 points (PB 0.001). There was a significant negative correlation between IAS and the number of daily insulin injections (Table 3). However, there was no significant correlation between IAS and HbA1c, age, the duration of diabetes or the duration of insulin use. There was no predictive association between gender or the use of syringe/pen, and IAS (Table 4). 4.3. General anxiety scores (GAS) The degree of glycaemic control as assessed by the HbA1c in subjects with high versus low general anxiety scores (GAS] 8 and GASB8) was not significantly different (mean HbA1c (S.D.), 9.3 (2.0) vs. 8.9 (1.7)%). Nor was there a significant correlation between HbA1c and GAS (Table 3). The median IAS was 1 point in the GASB 8 group and 3 points in the GAS ] 8 group (PB 0.001). A significant correlation was also found between IAS and GAS (Table 3).
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Equal numbers of patients who had avoided injections were seen in the high and low general anxiety groups. However the proportion of patients avoiding injections in the high general anxiety group was significantly greater (28%) compared with the low general anxiety group (9%) (P B0.05). GAS was significantly predicted by previous injection avoidance as seen in Table 4. Poisson regression analysis also showed that the mean GAS for injection avoiders was almost twice that for non-avoiders (mean GAS ratio 1.96 (95% CI 1.44–2.66), P B0.001). A total of 30 patients (35%) in the GASB 8 group and 18 patients (62%) in the GAS] 8 group expressed concern at having to inject more frequently (P B 0.01). GAS was significantly predicted by expressed concern at increased injection frequency (Table 4). Poisson regression analysis also showed that the mean GAS was significantly higher for patients expressing concern at having to inject more frequently than for those who did not (mean GAS ratio 1.62 (95% CI 1.21 – 2.19), P= 0.001). Age, duration of diabetes, duration of insulin use and the number of daily injections were not significantly correlated with GAS (Table 3). GAS was also not significantly predicted by gender or by the use of pen or syringe (Table 4).
5. Discussion The most important finding from this study is that a considerable number of patients (approximately a quarter) have a psychological problem
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with injecting insulin, associated with a high injection anxiety or general anxiety score. This may be clinically relevant as compliance and treatment flexibility are essential factors in achieving optimal glycaemic control. We have also shown that patients who have previously avoided insulin injections or who express concern at having to inject more frequently, have higher general anxiety scores. This would suggest that in these patients, injection anxiety may be part of a more generalised psychological disorder. Furthermore, our use of the anxiety subscale from the Hospital Anxiety and Depression Scale may not differentiate adequately between anxiety, depression and other psychiatric disorders. Those four patients with very high injection anxiety scores (i.e. IAS] 10), may have had a distinct injection phobia, an important and perhaps underdiagnosed condition. However this study was not designed specifically to diagnose this disorder as the questionnaire acts as a descriptive tool designed to identify patients with symptoms which may be related to injection phobia or anxiety. Our study did not show any significant correlations between injection or general anxiety and gender, age, the duration of diabetes, or the duration of insulin use. Women appeared to have higher general anxiety scores than men, a finding consistent with other studies [9,10], but the study was not powerful enough for the difference in GAS to be statistically significant. Furthermore our group was generally older, with long-standing diabetes.
Table 4 Association (Somers’ D) of measured variables and injection anxiety score (IAS) and general anxiety score (GAS)a Variable
IAS
GAS
Somers’ D Previous injection avoidance Concern at increased injection frequency Female gender Use of pen Use of syringe a
Somers’ D (95% CI).
Not Not 0.05 0.15 0.06
applicable applicable (−0.15–0.26) (−0.41–0.11) (−0.35–0.22)
P-value
Somers’ D
P-value
NS NS NS
0.55 (0.29–0.81) 0.41 (0.21–0.60) 0.14 (−0.08–0.36) 0.06 (−0.21–0.32) −0.12 (−0.35–0.11)
PB0.001 PB0.001 NS NS NS
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The relationship between assessed psychological parameters and glycaemic control may have important therapeutic implications. In the study by Berlin at al. [1], poor glycaemic control in patients with Type 1 diabetes was associated with higher levels of anxiety-depression and phobic symptoms. In addition they showed that such patients performed fewer blood glucose measurements per day. One further study showed that co-existent psychiatric illness was associated with a higher observed HbA1c (10.8%) as compared with those never psychiatrically ill where the mean HbA1c was 9.6% (P= 0.02) [10]. Although our study did not show a significant difference in HbA1c between the higher and lower scoring injection and general anxiety groups, the mean HbA1c concentration was higher in those with higher injection anxiety scores. Diabetic patients (both Type 1 and Type 2) with anxiety related to insulin injections, may develop their symptoms either before or soon after they are given the diagnosis of diabetes. Ost [11] suggested that injection phobia is frequently acquired in childhood as a result of negative conditioning. However others have suggested that initial anxiety over injections does not invariably result in a poor long-term outcome [12]. In that study, children whose mothers had a low level of general distress at baseline, had better metabolic control in the long-term. Needle phobia or injection-related anxiety are not the only psychological factors which may affect compliance with insulin treatment. White et al. [13] identified patients who had a passive dependent approach to diabetes, as having worse glycaemic control. In addition, aggressive glycaemic control increases the risk of hypoglycaemia [14], and this complication of treatment may increase anxiety and fear in some patients. The education of patients and their families together with the evaluation of existing knowledge regarding hypoglycaemia, is essential for self-care and may improve compliance [15]. Older patients with Type 2 diabetes may provide a therapeutic dilemma distinct from the problems seen in patients with Type 1 diabetes. These patients may be treated with combinations of oral hypoglycaemic agents and may initially resist the
need for insulin therapy. Interestingly a study by Hunt et al. [16], showed that patients with Type 2 diabetes clearly understood the benefits of insulin use. However they did have concerns regarding pain from injection, hypoglycaemia, proper injection technique and the potential for insulin to cause health problems. These results would therefore suggest that health professionals should avoid negatively emphasising such concepts and should address these questions in a positive and reassuring manner. We believe that the results of this study have highlighted the role of an insulin injection anxiety questionnaire. It has the potential for the diabetes care team to identify patients who may be having psychological problems with their insulin treatment. However further psychological evaluation would be required in order to define concurrent disorders which may be associated with insulin injection anxiety. The identification of such disorders would facilitate the focus of appropriate physical and psychological treatments. Injectionrelated and general anxiety are common in patients attending a hospital-based diabetes clinic. The identification of patients with injection-related phobia and anxiety [2], as well as those with other psychiatric disorders, is an important aspect towards helping these patients take control of their diabetes management.
Appendix A. Insulin Treatment Questionnaire
HbA1c……… Male/Female Age……… How long have you had diabetes? ……years. Do you use: Pen device Yes No How long have you injected insulin? ……years. Syringe Yes No Number of injections per day? 1 2 3 4 5 other…… How would you describe your feeling regarding daily injections? Unconcerned Mild anxiety Moderate anxiety Fear Are these feelings excessive or Yes No unreasonable?
A. Zambanini et al. / Diabetes Research and Clinical Practice 46 (1999) 239–246
Have you ever avoided injecYes tions because of these feelings?
No
When you are injecting, how would you describe your feelings? Unconcerned Mild anxiety Moderate anxiety Fear If you had to inject insulin more frequently would this trouble you? Does your feeling about injections interfere with your daily life?
Yes
No
Yes
No
Have you developed any of the before an injection? Palpitations/ Pounding heart Sweating Trembling or shaking Feeling short of breath or smothered Feeling of choking Chest pain or discomfort Nausea or ‘tummy pains’ Dizziness/unsteady/light-headed or faint Feelings of being detached from yourself or unreal Fear of losing control or going crazy Fear of dying Numbness or tingling sensations Chills or hot flushes
following Yes Yes Yes Yes
No No No No
Yes Yes Yes Yes
No No No No
Yes
No
Yes
No
Yes Yes Yes
No No No
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Worrying thoughts go through my mind: A great deal of the time
A lot of the time
From time to time but not
too often Only occasionally
I can sit at ease and feel relaxed: Definitely Usually Not often Not at all
I get a sort of frightened feeling like ‘butterflies’ in the stomach: Not at all Occasionally Quite often Very often
I feel restless as if I have to be on the move Very much indeed
Quite a lot
Not very much
Not at all
I get sudden feelings of panic: Very often indeed Quite often Not very often Not at all
Please tick one box only: I feel tense or ‘wound up’ Most of the time A lot of the time Occasionally Not at all
References
I get a sort of frightened feeling as if something awful is about to happen: Very definitely and quite badly
Yes, but not too badly
A little, but it doesn’t worry me
Not at all
[1] I. Berlin, J.C. Bisserbe, E. Renate, et al., Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycaemic control in Type 1 diabetic adults, Diabetes Care 20 (1997) 176 – 178. [2] A. Zambanini, M.D. Feher, Needle phobia in Type 1 diabetes mellitus, Diabetic Med. 14 (1997) 321 – 323. [3] American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed, American Psychiatric Association, Washington, DC, 1994, pp. 405 – 411. [4] A.S. Zigmond, R.P. Snaith, The Hospital Anxiety and Depression Scale, Acta Psychiatr. Scand. 67 (1983) 361 – 370.
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[5] K. Meadows, N. Steen, E. McColl, et al., The Diabetes Health Profile (DHP): a new instrument for assessing the psychosocial profile of insulin requiring patients — development and psychometric evaluation, Qual. Life. Res. 5 (1996) 242 – 254. [6] A.L. Carrington, S.K. Mawdsley, M. Morley, J. Kincey, A.J. Boulton, Psychological status of diabetic people with or without limb disability, Diabetes Res. Clin. Pract. 32 (1996) 19 – 25. [7] K.S. Akinlade, J.U. Ohaeri, M.A. Suberu, The psychological condition of a cohort of Nigerian diabetic subjects, Afr. J. Med. Med. Sci. 25 (1996) 61–67. [8] R.H. Somers, A new asymmetric measure of association for ordinal variables, Am. Sociol. Rev. 21 (1962) 799– 811. [9] M. Peyrot, Levels and risks of depression and anxiety symptomatology among diabetic adults, Diabetes Care 20 (1997) 585 – 590. [10] P.J. Lustman, L.S. Griffith, R.E. Clouse, P.E. Cryer, Psychiatric illness in diabetes: relationship to symptoms and glucose control, J. Nerv. Ment. Dis. 174 (1986) 736 – 749.
[11] L.G. Ost, Acquisition of blood and injection phobia and anxiety response patterns in clinical patients, Behav. Res. Ther. 29 (1991) 323 – 332. [12] G. Thernlund, G. Dahlquist, B. Hagglof, et al., Psychological reactions at the onset of insulin-dependent diabetes mellitus in children and later adjustment and metabolic control, Acta Pediatr. 85 (1996) 947 – 953. [13] R. White, P. Tata, T. Burns, Mood, learned resourcefulness and perceptions of control in Type 1 diabetes mellitus, J. Psychosom. Res. 40 (1996) 205 – 212. [14] The Diabetes Control and Complications Trial Research Group, The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, N. Engl. J. Med. 329 (1993) 977 – 986. [15] J.A. Drass, R.H. Feldman, Knowledge about hypoglycaemia in young women with Type 1 diabetes and their supportive others, Diabetes Educ. 22 (1996) 34 – 38. [16] L.M. Hunt, M.A. Valenzuela, J.A. Pugh, NIDDM patients’ fears and hopes about insulin therapy. The basis of patient reluctance, Diabetes Care 20 (1997) 292 – 298.
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