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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy; Anxiety in Pregnancy
• Intervention / Treatment: Behavioral: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group; Behavioral: The group who received diet therapy and practiced their daily activities.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya
    • Konyaaltı, Antalya, Turkey, 07050
      • Akdeniz Üniversitesi Hemşirelik Fakültesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention group; 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; The group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.
Active Comparator: Control group; 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.; The group who received diet therapy and practiced their daily activities.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Nilüfer Tok Yanık, Ege Üniversitesi Hemşirelik Fakültesi

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; gestational diabetes; Health Belief Model; Blood Sugar; Progressive Relaxation Exercise
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Anxiety Disorders; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 10428916

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No