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

NCT05611541 | Completed

• 1 other identifier: 10428916
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Anxiety in Pregnancy

Keywords

gestational diabetes; Health Belief Model; Progressive Relaxation Exercise; Anxiety; Blood Sugar

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (2)

• Weekly physical activity level

  8 weeks

• Level of compliance with the weekly diet

  8 weeks

Study Arms (2)

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.

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.

Behavioral: The group who received diet therapy and practiced their daily activities.

Interventions

Diet therapy, Progressive Muscle Relaxation training, Progressive Muscle Relaxation group BEHAVIORAL

The group that received Progressive Muscle Relaxation training and applied progressive muscle relaxation for 8 weeks.

İntervention group

The group who received diet therapy and practiced their daily activities. BEHAVIORAL

The group who received diet therapy and practiced their daily activities.

Control group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 24 weeks of pregnancy,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Akdeniz Üniversitesi Hemşirelik Fakültesi

Konyaalti, Antalya, 07050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational; Anxiety Disorders

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Nilüfer Tok Yanık

  Ege Üniversitesi Hemşirelik Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Using a computer program, the researchers randomly placed pregnant women who received dietary advice into either the intervention group or the control group.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: November 10, 2022
• Study Start: October 1, 2018
• Primary Completion: October 30, 2020
• Study Completion: September 30, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

TU (1)