Study design
The study was carried out as a single blind parallel clinical trial. The study population consisted of patients with diabetes type 2 visiting the Clinic of Velayat Educational Hospital, Ghazvin-Iran from 2018 to 12 to 2020–01.
Participants
The number of people participating in this study was determined using the first-type error with 0.05 and the second-type error 0.8; and using the amount of fear of hypoglycemia in the study of Walker et al. [28], 36 patients in each group. The inclusion criteria were: having diabetes type 2, hypoglycemic experience and diagnosed with the fear of hypoglycemia, no history of mental disorders, no visual impairment and strabismus, older than 25 years, no history of seizure, and full consent to participate in the study. Patients with symptoms of low blood sugar (such as sweating, confusion, lack of awareness, tremor, irregular movement, sudden changes in behavior or mood, hunger, burning or tingling sensation around the mouth, difficulty in concentrating, headache, and pale skin) were selected and then examined by researchers for fear of hypoglycemia.
For evaluation of fear of hypoglycemia in patients, questions such as »Are you afraid of recurrence of low blood sugar?“ “Have you reduced your activities following the fear of low blood sugar?” “Does the fear of blood sugar drop result in a reduction in insulin dose or consumption of oral anti-diabetes tablets?” “Have you consumed a lot of carbohydrates for fear of low blood sugar?” “Do you fear the blood sugar drop in your sleep?” were used. The exclusion criteria were failure to continue EMDR (impaired concentration during treatment and the occurrence of conditions such as dizziness) and reluctance to continue the study.
Sampling
In this study, the sampling was made available. The researchers examined 520 diabetic type 2 patients and finally selected 72 patients who were eligible for the study (Fig. 1). Patients using lottery cards were divided into two groups: intervention and control. In this way, blue and red cards inside the lottery basket were presented to the patients, and each patient chose one card. In this study, red cards were assigned to the intervention group and blue cards to the control group.
Data gathering tools
The required data were collected using a demographic questionnaire, Hypoglycemia fear survey, and Hypoglycemia severity inventory. The demographic questionnaire covered age, gender, job, education, marital status, history of diabetes, blood sugar test, awareness of insulin function, and number of hypoglycemia over the past 6 months. Fear of hypoglycemia was measured using the worry scale of fear of hypoglycemia questionnaire (HYPOGLYCEMIA FEAR SURVEY –II). This questionnaire, designed by Cox et al., included two sub-scales “worry” and “behavior.” The” worry” sub-scale is covered by 18 questions that measure fear of hypoglycemia over the past 6 months with score range from 0 to 72. The questions in this sub-scale are designed based on a five-point scale (0-- 4) and validity and reliability of the questionnaire have been supported by many studies. Momeni et al. [29] studied the validity and reliability of the tool in Iran, and obtained the Cronbach’s alpha equal to 0.96. In order to determine the severity of hypoglycemia, it was categorized based on the guideline of USA hypoglycemia association [30] in 3 groups as mild (no or low disorder in daily activities without need to treat the symptoms), moderate group (disorder in doing some activities without need for treatment), and severe group (dependence on others to treat the symptoms); and patients chose the appropriate option.
Intervention
The intervention group received the EMDR intervention through two 45 min individual sessions in the internal ward examination room of the hospital. In each intervention session, the intervention was performed by the researcher in several stages. Each step consisted of 24 two-way cycles using finger movements [31], each cycle lasting 1 s, and the distance between the patient and the therapist during the intervention was 1 m. The intervention was performed with EMDR Standard Protocol on eight steps [32]. In phase one, a complete biography of the clients was obtained, the events that led to pathological responses in the mind were determined, and the stimuli that evoked these responses were identified. In step two, EMDR intervention and its implementation conditions were explained to patients. In step three, patients were asked to identify and focus on an image that best remembered their negative cognitions, and then they were asked to identify a positive image. In stage four, desensitization, negative cognitions were performed; in stage five, patients were asked to visualize positive cognitions in their minds. In step six, after replacing the positive cognition, patients were asked to imagine positive cognition and negative events in their minds and then review their minds and bodies and report negative experiences. In stage seven, psychological support was provided to the patients and appropriate information was given to them, and in stage eight, a reassessment was performed to ensure that all patients’ negative experiences were processed. The intervention group filled out the demographic form, hypoglycemia fear survey, and hypoglycemia severity scale before the intervention; they also filled out the hypoglycemia severity scale 1 month and 3 months after the intervention. The control group received no intervention and they only filled out the questionnaires before intervention, 1 month after and 3 months after the intervention.
Ethical concerns
Sampling was started after securing a medical ethics license under No.: IR.QUMS.REC.1397.230 (Ethics Committee of Qazvin University of Medical Sciences) and an informed letter of consent from the participants. In addition, all the items in the Declaration of Helsinki were observed [33]. All patients were informed that the participation is voluntary and the collected information will remain confidential. All of the patients completed a written consent to participate in the study.
Data analysis
The collected data were analyzed using descriptive statistics (frequency, percentage, mean, and SD) on SPSS (version.23) (P = 0.05). To compare the fear of hypoglycemia between the two groups in before intervention, after intervention and follow up, repeated measure ANOVA was used. The effect of the intervention was also measured by Cohen’s d test.