Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes
NCT ID: NCT06970886
Last Updated: 2025-05-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-01
Study Completion Date
2027-04-25
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Gestational Diabetes Mellitus in Pregnancy
Anxiety
Blood Sugar; High
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
Since the music intervention in this study will be conducted by the researcher and the cooperation of the pregnant participants is required, masking cannot be applied to the researcher or the participants. To prevent reporting bias during the writing of the research report, masking will be implemented during the statistical analysis and interpretation of the findings. Evaluations will be conducted based on groups labeled as Group I, Group II, and Group III, without revealing the actual group names.
Study Groups
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Rhythm-Based Active Music Engagement Group
Participants will engage in active rhythm-based music making sessions under the guidance of the researcher. Sessions will be conducted once daily for 3 consecutive days. Each session will last approximately 30 minutes and involve creating rhythms using hand drums and body percussion. Participants will follow simple rhythmic patterns designed to promote relaxation and engagement.
Group Type
EXPERIMENTAL
Rhythm-Based Music Intervention
Intervention Type
BEHAVIORAL
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.
Rhythm-Based Music Listening Group
Participants will passively listen to pre-recorded rhythm-based music selected by the researcher. Listening sessions will occur once daily for 3 consecutive days. Each session will last approximately 30 minutes. Participants will be seated comfortably and instructed to focus on the rhythm and flow of the music without actively creating sounds.
Group Type
EXPERIMENTAL
Rhythm-Based Music Intervention
Intervention Type
BEHAVIORAL
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.
Control Group
Participants in the control group will receive routine prenatal care without any additional music intervention during the study period.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Ege University
OTHER
Sponsor Role
collaborator
Esin Ceber Turfan, Professor
OTHER
Sponsor Role
lead
Responsible Party
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Esin Ceber Turfan, Professor
Dean, Faculty of Health Sciences
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Esin Ceber Turfan, Prof
Role: PRINCIPAL_INVESTIGATOR
Ege University
Locations
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İzmir City Hospital
Izmir, , Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
Central Contacts
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Facility Contacts
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References
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.sbb.gov.tr/wp-content/uploads/2023/12/On-Ikinci-Kalkinma-Plani_2024-2028_11122023.pdf
T.C. Strateji ve Bütçe Başkanlığı. "On İkinci Kalkınma Planı (2024-2028)".
http://www.who.int/publications-detail-redirect/9789240057142
WHO guide for integration of perinatal mental health in maternal and child health services.
http://www.who.int/publications-detail-redirect/9789241506096
WHO Traditional Medicine Strategy: 2014-2023.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EgeUTYilmaz001
Identifier Type: -
Identifier Source: org_study_id
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