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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group
The group who received diet therapy and practiced their daily activities.
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring gestational diabetes, Health Belief Model, Progressive Relaxation Exercise, Anxiety, Blood Sugar

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Akdeniz Üniversitesi Hemşirelik Fakültesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

İntervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Fasting blood glucose value
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Fasting blood glucose value
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Fasting blood glucose value
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 12, 2022
Last Updated
November 3, 2022
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05611541
Brief Title
The Effect of Model-Based PMR Training on Anxiety and Blood Sugar Levels to Women With Gestational Diabetes
Acronym
GDM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy
Keywords
gestational diabetes, Health Belief Model, Progressive Relaxation Exercise, Anxiety, Blood Sugar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care Provider
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group
Intervention Description
The group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
The group who received diet therapy and practiced their daily activities.
Intervention Description
The group who received diet therapy and practiced their daily activities.
Primary Outcome Measure Information:
Title
Anxiety Level
Description
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.
Time Frame
Before the intervention
Title
Anxiety Level
Description
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.
Time Frame
After the 4-week intervention period.
Title
Anxiety Level
Description
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.
Time Frame
After the 8-week intervention period.
Title
Fasting blood glucose value
Description
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Time Frame
Before the intervention
Title
Fasting blood glucose value
Description
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Time Frame
After the 4-week intervention period.
Title
Fasting blood glucose value
Description
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Time Frame
After the 8-week intervention period.
Title
Postprandial 1 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL.
Time Frame
Before the intervention
Title
Postprandial 1 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL.
Time Frame
After the 4-week intervention period.
Title
Postprandial 1 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 1 hour blood glucose. Mean 1 hour blood glucose is defined as <140 mg/dL.
Time Frame
After the 8-week intervention period.
Title
Postprandial 2 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL.
Time Frame
Before the intervention
Title
Postprandial 2 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL.
Time Frame
After the 4-week intervention period.
Title
Postprandial 2 hour blood glucose value
Description
Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL.
Time Frame
After the 8-week intervention period.
Secondary Outcome Measure Information:
Title
Weekly physical activity level
Description
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.
Time Frame
8 weeks
Title
Level of compliance with the weekly diet
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilüfer Tok Yanık
Organizational Affiliation
Ege Üniversitesi Hemşirelik Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz Üniversitesi Hemşirelik Fakültesi
City
Konyaaltı
State/Province
Antalya
ZIP/Postal Code
07050
Country
Turkey

12. IPD Sharing Statement

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

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