Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes

Официальное название

Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Anxiety Levels [Срок оценки: 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.]

Вторичные конечные точки (2)

• Blood Glucose Levels [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• İzmir City Hospital — Izmir

Публикации

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. PMID 29370047
• Adhikari K, Patten SB, Williamson T, Patel AB, Premji S, Tough S, Letourneau N, Giesbrecht G, Metcalfe A. Assessment of anxiety during pregnancy: are existing multiple anxiety scales suitable and comparable in measuring anxiety during pregnancy? J Psychosom Obstet Gynaecol. 2021 Jun;42(2):140-146. doi: 10.1080/0167482X.2020.1725462. Epub 2020 Feb 14. PMID 32056477
• E Aksoy Y, D Yilmaz S, Kilic S. The effect of music therapy on non-stress test results and anxiety levels in high-risk pregnant women: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13281. doi: 10.1111/ijn.13281. Epub 2024 Jun 20. PMID 39031663
• Alakidi A, Dimitrov I, Bivolarska AV, Mihaylova V. Changes in the levels of marker molecules salivary alpha-amylase and cortisol as a stress response to everyday activities of general practitioners in rural areas of the Republic of Bulgaria. Rural Remote Health. 2023 Jan;23(1):7318. doi: 10.22605/RRH7318. Epub 2023 Jan 30. PMID 36710477
• Algül G, Törüner EK. Müzik Temelli Uygulamaların Pediatri Hastalarında Kullanımı ve Hemşirelik Bakımına Etkisi: Geleneksel Derleme. Geleneksel ve Tamamlayıcı Tıp Dergisi.2022; 5(1): 68-74. https://doi.org/10.5336/jtracom.2021-87787
• Aydemir M, Makaraci Y, Avci B, Urkmez YC, Cintineo HP. The Psychophysiologic Stress and Salivary Cortisol and Alpha-Amylase Awakening Responses to Cross-Country Running Competitions in National-Level Female Athletes. J Strength Cond Res. 2025 May 1;39(5):e676-e683. doi: 10.1519/JSC.0000000000005055. Epub 2025 Mar 4. PMID 40030101
• Baltaci N, Dogan Yuksekol O, Koc E, Ulucan M. The effects of listening to lullabies and self-selected music at home on prenatal stress and anxiety in nulliparous pregnant women: A randomized-controlled study. Health Care Women Int. 2024;45(5):562-578. doi: 10.1080/07399332.2023.2196510. Epub 2023 Apr 3. PMID 37010820
• Blair J, Adaway J, Keevil B, Ross R. Salivary cortisol and cortisone in the clinical setting. Curr Opin Endocrinol Diabetes Obes. 2017 Jun;24(3):161-168. doi: 10.1097/MED.0000000000000328. PMID 28375882

Идентификаторы

NCT: NCT06970886 · EgeUTYilmaz001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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