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Starting soon Not applicable

Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes

NCT06970886 · tracked via the Priya Life Science Turkey tracker
Sponsor
Esin Ceber Turfan, Professor
Phase
Not applicable
Started
2025-09-01
Last updated
2025-05-22

Condition(s) studied

Gestational Diabetes Mellitus in PregnancyAnxietyBlood Sugar; High

Investigational drug(s) / intervention(s)

Rhythm-Based Music Intervention

Rhythm-Based Music Intervention: The rhythm-based music intervention is designed to reduce anxiety and improve emotional well-being in pregnant women with gestational diabetes. This intervention involves structured music sessions, utilizing rhythm as a therapeutic tool to engage participants in either active creation or passive listening. The intervention aims to promote relaxation, reduce stress, and support overall psychological health by leveraging the emotional and cognitive effects of rhythm and music.

Study summary

This study is for people who have gestational diabetes, a type of diabetes that happens during pregnancy. People with gestational diabetes may feel more anxious than others during pregnancy. This anxiety can affect their health and their baby's health.

The goal of this study is to see if rhythm-based music can help lower anxiety and improve blood sugar and stress hormone levels. Music may be a safe and low-cost way to support emotional and physical health during pregnancy.

Researchers will test two types of music activities:

Listening to rhythm-based music

Doing rhythm-based music and breathing exercises

The study will include 180 pregnant participants. They will be randomly placed into one of three groups. Each group will be at a different hospital to prevent crossover. Two groups will receive music activities, and the third group will receive usual care.

Participants will stay in the hospital for 3 days. During that time:

Anxiety will be measured on day 1 and day 3 using a short questionnaire

Blood sugar will be measured 3 times a day (morning, afternoon, evening)

Saliva samples will be collected on day 3 to measure cortisol (a stress hormone)

Researchers will also record any medications used by participants.

This study may show that music helps lower anxiety and improve health for people with gestational diabetes. It may also support the use of music as a helpful, non-drug option during pregnancy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Voluntarily agree to participate in the study with informed written consent * Diagnosed with Gestational Diabetes Mellitus (GDM) and currently hospitalised * In the third trimester of pregnancy * Over the age of 18 * Have a live, single fetus Exclusion Criteria: * Any condition preventing participation in rhythm-based music making and listening (e.g., hearing, vision, or speech impairments) * Regular and routine music listening habits during pregnancy * Physical limitations or restrictions * Mental or cognitive disorders requiring medication * Use of corticosteroids or medications containing corticosteroids * Known fetal abnormalities * Systemic diseases other than GDM (e.g., Hypertension, Type 1 or Type 2 Diabetes, Thyroid disorders, etc.) * Body mass index (BMI) of 30 or higher * Discharge from the hospital before the 3rd day of the intervention

Primary outcome measure(s)

  • Anxiety Levels — Anxiety levels will be assessed at two time points: Day 1 (Pre-intervention) and Day 3 (Post-intervention). The first measurement will occur before the intervention, and the second will be taken immediately after the 3-day music intervention.
    Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), at baseline (Day 1) and post-intervention (Day 3). Anxiety level was assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State). The scale consists of 20 items with scores ranging from 20 to 80. Higher scores indicate greater anxiety, representing a worse outcome.

Trial sites (1)

FacilityCityRegionStatus
İzmir City Hospital Izmir Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06970886 on ClinicalTrials.gov ↗ ← All trials in Turkey