Clinical trial NCT06970886: Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes
Official title: Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Anxiety
Blood Sugar; High
Keywords: Anxiety
Blood glucose
Gestational diabetes
Salivary cortisol
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2025-05-14
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Gestational diabetes is a condition where blood sugar levels become high during pregnancy. This condition can affect both the pregnant person and their baby, leading to health problems during and after pregnancy. People with gestational diabetes often experience higher levels of anxiety. This can make it harder to manage blood sugar and may affect the baby's development.

Music is a safe and low-cost way to support mental and emotional health. Listening to or creating rhythm-based music may help reduce anxiety. Some research shows that music can help people with diabetes, but there are very few studies that look at its effect in pregnancies affected by gestational diabetes.

This study will explore whether rhythm-based music activities can help lower anxiety, blood sugar levels, and cortisol, a hormone related to stress.

A total of 180 pregnant participants with gestational diabetes will be part of the study. They will be randomly assigned to one of three groups:

Group 1: Will listen to rhythm-based music

Group 2: Will take part in guided sessions that include rhythm-based music activities and breathing exercises

Group 3: Will receive standard hospital care without music

Each group will be located at a different hospital in İzmir, Türkiye. This will help prevent participants in different groups from influencing each other.

The music activity will happen over three days, during the participants' hospital stay. Researchers will collect information by:

Measuring anxiety levels using a standard questionnaire on day 1 and day 3

Measuring blood sugar three times a day (morning, afternoon, evening)

Collecting saliva samples to measure cortisol before and after the music activity on day 3

Recording any medications used by participants

This study may show that rhythm-based music is a useful tool to support the health of people with gestational diabetes. If effective, this approach could be used as a non-drug way to lower anxiety and improve health outcomes for both the pregnant person and the baby. The findings could also support using more non-drug, supportive care methods in pregnancy and lead to new research and international collaboration.

Eligibility criteria: 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 outcomes:
measure: Anxiety Levels
timeFrame: 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:
measure: Blood Glucose Levels
timeFrame: 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.
measure: Salivary Cortisol Levels
timeFrame: 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.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir City Hospital
Study officials:
affiliation: Ege University
name: Esin Ceber Turfan, Prof
role: PRINCIPAL_INVESTIGATOR
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