The Effect of Model-Based PMR Training on Anxiety and Blood Sugar Levels to Women With Gestational Diabetes

Study Overview
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Brief Summary
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This research is a randomized controlled experimental study to evaluate the effects of PMR application based on HBM in terms of blood sugar and anxiety levels in women with GDM. 34 pregnant women who applied PMR formed the intervention group and 34 pregnant women who did not practice PMR formed the control group. The intervention group received Progressive Muscle Relaxation Training. It was determined that there was a statistically significant difference between the last follow-up state anxiety score averages, and the intermediate and final follow-up trait anxiety scores between the intervention and control groups. It was determined that PMR provided a decrease in psychological anxiety levels in pregnant women with GDM, and did not have a positive effect on physiologically fasting, 1 hour postprandial and 2 hour postprandial blood glucose levels. PMR training prepared based on HBM is a method that nurses can perform independently to ensure the psychological well-being of pregnant women with GDM.

Detailed Description
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Aim: This research is a randomized controlled experimental study that includes evaluation of the effects of PMR based on the SIM model in terms of blood sugar and anxiety levels in women with GDM. Method: The sample group consisted of 68 pregnant women who were diagnosed with GDM for the first time in the Health Sciences University Antalya Training and Research Hospital Gynecology and Obstetrics Polyclinic. 34 pregnant women who applied PMR constituted the intervention group and 34 pregnant women who did not practice PMR constituted the control group. Data collection was done by the researcher. The Informed Consent Form, Pregnant Diagnosis Form, State-Trait Anxiety Inventory-STAI were applied to women with GDM in the intervention and control groups before the intervention. Progressive Muscle Relaxation Training was given to the intervention group. Pregnant women in the intervention group applied PMR 1 hour after dinner, 5 days a week, for 8 weeks. The International Physical Activity Questionnaire-IPAQ and Diet Compliance Questionnaire were applied to both groups every week for eight weeks.The State-Trait Anxiety Inventory-STAI was administered to both groups for interim follow-up 4 weeks after the intervention, and the postprandial 1st hour and 2nd hour postprandial blood glucose values were measured.The State-Trait Anxiety Inventory-STAI was administered to both groups for the final follow-up, 8 weeks after the intervention, and the postprandial 1st hour and 2nd hour postprandial blood glucose values were measured.The data in the research were analyzed using the IBM SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.

Official Title
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The Effect of Health Belief Model-Based Progressive Muscle Relaxation Training on Anxiety and Blood Sugar Levels to Women With Gestational Diabetes: A Randomised Controlled Trial

Conditions
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Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy

Intervention / Treatment
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* Behavioral: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group
* Behavioral: The group who received diet therapy and practiced their daily activities.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 24 weeks of pregnancy, 19-45 years old (fertility period), no history of diabetes before pregnancy, First time diagnosed with GDM, Body Mass Index (BMI) at a normal level of 18.5-24.9 Receiving information about diabetes nutrition during pregnancy from the SBUAEAH Diet Polyclinic. Those who do not actively participate in birth preparation classes Literate, Do not have any barriers to prevent communication (hearing, hearing impairment, etc., use of languages other than Turkish), Residing in Antalya city center Agreeing to blood glucose measurements by the researcher Not using complementary therapies based on mind-body techniques such as acupuncture and massage during the research. Exclusion Criteria: Having multiple pregnancies Having a diagnosed disease other than GDM (polyhydramnios, multiple pregnancy, pregnancy-induced hypertension, cardiac problems) It consisted of women who did not accept to participate in the research.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using a computer program, the researchers randomly placed pregnant women who received dietary advice into either the intervention group or the control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: İntervention group<br>Progressive Muscle Relaxation Training Program; The training was carried out in a single session for 2 hours and a break of 10-15 minutes was given. Pregnant women were instructed to perform PMR at least 1 hour after dinner 5 days a week. | Behavioral: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group<br>* The group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.<br>|
| Active Comparator: Control group<br>The Progressive Muscle Relaxation Training Program and the Progressive Muscle Relaxation were not applied. The pregnant women were asked to continue their normal daily activities for 8 weeks. | Behavioral: The group who received diet therapy and practiced their daily activities.<br>* The group who received diet therapy and practiced their daily activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Level | State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. | Before the intervention | 
| Anxiety Level | State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. | After the 4-week intervention period. | 
| Anxiety Level | State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. | After the 8-week intervention period. | 
| Fasting blood glucose value | Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL. | Before the intervention | 
| Fasting blood glucose value | Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL. | After the 4-week intervention period. | 
| Fasting blood glucose value | Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL. | After the 8-week intervention period. | 
| Postprandial 1 hour blood glucose value | Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL. | Before the intervention | 
| Postprandial 1 hour blood glucose value | Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL. | After the 4-week intervention period. | 
| Postprandial 1 hour blood glucose value | Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL. | After the 8-week intervention period. | 
| Postprandial 2 hour blood glucose value | Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL. | Before the intervention | 
| Postprandial 2 hour blood glucose value | Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL. | After the 4-week intervention period. | 
| Postprandial 2 hour blood glucose value | Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL. | After the 8-week intervention period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly physical activity level | International Physical Activity Questionnaire (IPAQ) Short Form. The IPAQ consists of a total of seven questions questioning short form walking, moderate-intensity physical activity, vigorous physical activity, and time spent sitting. Total score calculation, metabolic equation (MET) values given to activities (vigorous activity=8 METs, moderate-intensity activity=4 METs, walking=3.3 METs, sitting-=1.5 METs), duration (minutes) and frequency of activities (number of days) multiplied and weekly MET-min scores are obtained. Physical activity levels according to total physical activity score; Those with 0-600 MET-minutes/week are classified as physically inactive, those with 600-3000 MET-minutes/week with low physical activity level, those with over 3000 MET-minutes/week as having adequate physical activity level. | 8 weeks | 
| Level of compliance with the weekly diet | Diet Compliance Questionnaire is a questionnaire consisting of 7 questions structured by the researcher using the literature to determine the diet compliance status of pregnant women, the reasons for not complying with the diet, the status of skipping meals in the diet and the reasons for skipping meals. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, Health Belief Model, Progressive Relaxation Exercise, Anxiety, Blood Sugar