Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Anxiety Levels
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Rhythm-Based Music Intervention (Behavioral)
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.
干预措施: Rhythm-Based Music Intervention (Behavioral)
Control Group
Participants in the control group will receive routine prenatal care without any additional music intervention during the study period.
结局指标
主要结局
Anxiety Levels
时间窗: 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.
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.
次要结局
- 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.)
研究者
Esin Ceber Turfan, Professor
Dean, Faculty of Health Sciences
Ege University