Clinical trial NCT05611541: The Effect of Model-Based PMR Training on Anxiety and Blood Sugar Levels to Women With Gestational Diabetes
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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Anxiety in Pregnancy
Keywords: gestational diabetes
Health Belief Model
Progressive Relaxation Exercise
Anxiety
Blood Sugar
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 68
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Anxiety Level
timeFrame: Before the intervention
measure: Anxiety Level
timeFrame: After the 4-week intervention period.
measure: Anxiety Level
timeFrame: After the 8-week intervention period.
measure: Fasting blood glucose value
timeFrame: Before the intervention
measure: Fasting blood glucose value
timeFrame: After the 4-week intervention period.
measure: Fasting blood glucose value
timeFrame: After the 8-week intervention period.
measure: Postprandial 1 hour blood glucose value
timeFrame: Before the intervention
measure: Postprandial 1 hour blood glucose value
timeFrame: After the 4-week intervention period.
measure: Postprandial 1 hour blood glucose value
timeFrame: After the 8-week intervention period.
measure: Postprandial 2 hour blood glucose value
timeFrame: Before the intervention
measure: Postprandial 2 hour blood glucose value
timeFrame: After the 4-week intervention period.
measure: Postprandial 2 hour blood glucose value
timeFrame: After the 8-week intervention period.
Secondary outcomes:
measure: Weekly physical activity level
timeFrame: 8 weeks
measure: Level of compliance with the weekly diet
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Konyaaltı
country: Turkey
facility: Akdeniz Üniversitesi Hemşirelik Fakültesi
state: Antalya
Study officials:
affiliation: Ege Üniversitesi Hemşirelik Fakültesi
name: Nilüfer Tok Yanık
role: PRINCIPAL_INVESTIGATOR
References: