Gestational Diabetes Mellitus in PregnancyGDMNCT05611541

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

A study testing Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group and The group who received diet therapy and practiced their daily activities. in people with Gestational Diabetes Mellitus in Pregnancy and Anxiety in Pregnancy, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy
What is being tested?: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group and The group who received diet therapy and practiced their daily activities.
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2018to 30 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Akdeniz Üniversitesi Hemşirelik Fakültesi
Konyaalti, Antalya, 07050

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy
Being tested: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group, The group who received diet therapy and practiced their daily activities.
Keywords: gestational diabetes, Health Belief Model, Progressive Relaxation Exercise, Anxiety, Blood Sugar
Medical subject headings: Diabetes, Gestational, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation groupBehavioural
The group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.
The group who received diet therapy and practiced their daily activities.Behavioural
The group who received diet therapy and practiced their daily activities.

Study groups in NCT05611541
Study group	Role	What they receive
İntervention group	Experimental	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. Receives: Behavioral: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group
Control group	Active comparator	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. Receives: Behavioral: The group who received diet therapy and practiced their daily activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the 8-week intervention period.

Secondary outcomes (2)

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.
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201830 Sep 2021

First posted10 Nov 2022
Study start1 Oct 2018
Primary completion30 Oct 2020
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
More trials run by Ege UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Care provider
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05611541
Sponsor's protocol ID: 10428916
Acronym: GDM
Status last verified: Nov 2022
First submitted: 12 Sep 2022
Last updated: 10 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
RecruitingPhase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Gestational Diabetes Mellitus, Pregnancy, High Risk
Recruiting
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
Pre-Gestational Diabetes, Type2diabetes
Active, not recruiting
Westlake Precision Birth Cohort
Diabetes, Gestational, Pregnancy in Diabetics
Active, not recruiting
Wenzhou Gestational Diabetes Cohort
Gestational Diabetes Mellitus, Intrauterine Hyperglycemia

All Gestational Diabetes Mellitus in Pregnancy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05611541
Acronym / sponsor ID: GDM / 10428916
Conditions: Gestational Diabetes Mellitus in Pregnancy, Anxiety in Pregnancy
Keywords: gestational diabetes, Health Belief Model, Progressive Relaxation Exercise, Anxiety, Blood Sugar
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Ege UniversityUniversity, hospital or other
Study start: 1 Oct 2018 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 10 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
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.

Arm	Type	Receives
İntervention group	Experimental	Behavioral: Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation groupProgressive 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.
Control group	Active comparator	Behavioral: The group who received diet therapy and practiced their daily activities.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.

Who may qualify

Ages: 19 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation groupThe group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.	Behavioural	İntervention group
The group who received diet therapy and practiced their daily activities.The group who received diet therapy and practiced their daily activities.	Behavioural	Control group

Primary outcome

Anxiety Level
Time frame: Before the intervention
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
Time frame: After the 4-week intervention period.
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
Time frame: After the 8-week intervention period.
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
Time frame: Before the intervention
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Fasting blood glucose value
Time frame: After the 4-week intervention period.
Peripheral glucose values are recorded at the morning fasting. Mean fasting blood glucose is defined as <95 mg/dL.
Fasting blood glucose value
Time frame: After the 8-week intervention period.
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
Time frame: Before the intervention
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
Time frame: After the 4-week intervention period.
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
Time frame: After the 8-week intervention period.
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
Time frame: Before the intervention
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
Time frame: After the 4-week intervention period.
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
Time frame: After the 8-week intervention period.
Peripheral glucose values are recorded at the morning 2 hour blood glucose. Mean 2 hour blood glucose is defined as <120 mg/dL.

2 secondary outcomes

Weekly physical activity level
Time frame: 8 weeks
Level of compliance with the weekly diet
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.

Related trials for Gestational Diabetes Mellitus in Pregnancy

Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
RecruitingPhase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Gestational Diabetes Mellitus, Pregnancy, High Risk
Recruiting
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
Pre-Gestational Diabetes, Type2diabetes
Active, not recruiting
Westlake Precision Birth Cohort
Diabetes, Gestational, Pregnancy in Diabetics
Active, not recruiting
Wenzhou Gestational Diabetes Cohort
Gestational Diabetes Mellitus, Intrauterine Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nilüfer Tok Yanık principal investigator

Ege Üniversitesi Hemşirelik Fakültesi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Level (time frame: Before the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05611541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.