Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorEsin Ceber Turfan, Professor
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rhythm-Based Music Intervention
BehavioralThe 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Rhythm-Based Active Music Engagement GroupExperimental treatment 1 intervention
Group B: Rhythm-Based Music Listening GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety Levels
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.
Time frame
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.Secondary outcomes
1
Blood Glucose Levels
Blood glucose levels will be measured three times per day (morning, afternoon, evening) for 3 consecutive days, using a glucose meter. The average level for each day will be calculated.
Time frame
Blood glucose levels will be measured three times daily (morning, afternoon, and evening) over the course of 3 consecutive days: Day 1, Day 2, and Day 3. Measurements will be taken at the same time each day to ensure consistency.2
Salivary Cortisol Levels
Cortisol levels will be measured twice on Day 3, once before the intervention and once after the intervention, using a salivary cortisol test. Saliva samples will be collected and analyzed to assess changes in cortisol concentration, which serves as an indicator of stress.
Time frame
Salivary cortisol levels will be assessed twice on Day 3: once pre-intervention (before the music intervention) and once post-intervention (immediately after the intervention). Saliva samples will be collected at these time points.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: