Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes

NCT06970886 | Not Yet Recruiting

• 1 other identifier: EgeUTYilmaz001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Anxiety; Blood Sugar; High

Keywords

Anxiety; Blood glucose; Gestational diabetes; Salivary cortisol

Outcome Measures

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.

  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 (2)

• Blood Glucose Levels

  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.

• Salivary Cortisol Levels

  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.

Study Arms (3)

Rhythm-Based Active Music Engagement Group

EXPERIMENTAL

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.

Behavioral: Rhythm-Based Music Intervention

Rhythm-Based Music Listening Group

EXPERIMENTAL

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.

Behavioral: Rhythm-Based Music Intervention

Control Group

NO INTERVENTION

Participants in the control group will receive routine prenatal care without any additional music intervention during the study period.

Interventions

Rhythm-Based Music Intervention 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 Active Music Engagement Group; Rhythm-Based Music Listening Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This study is eligible for female participants only, as it focuses on pregnant women with gestational diabetes.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Esin Ceber Turfan, Professor: lead
• Ege University: collaborator

Study Sites (1)

İzmir City Hospital

Izmir, 35000, Turkey (Türkiye)

Location

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  PMID: 33953581 BACKGROUND

• Zhou LY, Zhang Y, Tian Y, Fu X, Wang LZ, Xie CG. Effect of music intervention on mental health in patients with diabetes mellitus: protocol for a systematic review and meta-analysis of randomizsed controlled trials. BMJ Open. 2020 Aug 20;10(8):e036268. doi: 10.1136/bmjopen-2019-036268.

  PMID: 32819943 BACKGROUND

Related Links

• T.C. Strateji ve Bütçe Başkanlığı. "On İkinci Kalkınma Planı (2024-2028)".
• WHO guide for integration of perinatal mental health in maternal and child health services.
• WHO Traditional Medicine Strategy: 2014-2023.

MeSH Terms

Conditions

Anxiety Disorders; Hyperglycemia; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Esin Ceber Turfan, Prof

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba Yilmaz, MSc

CONTACT

+905356790850; tugbayilmaz101@gmail.com

Esin Ceber Turfan, Prof

CONTACT

+905369662353; esin.ceber@ege.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean, Faculty of Health Sciences

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): April 25, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data will become available 1 year after publication and will be accessible for 5 years.
• Access Criteria: Qualified researchers with a sound research proposal and institutional review board (IRB) approval may request access to the de-identified data for academic research purposes. Requests will be evaluated by the principal investigator.

Locations

TU (1)