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

NCT ID: NCT05611541

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-09-30

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Anxiety in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Nilüfer Tok Yanık

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilüfer Tok Yanık

Role: PRINCIPAL_INVESTIGATOR

Ege Üniversitesi Hemşirelik Fakültesi

Locations

Akdeniz Üniversitesi Hemşirelik Fakültesi

Konyaalti, Antalya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

10428916

Identifier Type: -

Identifier Source: org_study_id