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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
180
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.
İzmir City Hospital
Izmir, Turkey (Türkiye)
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.
Time frame: 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.
Blood Glucose Levels
Blood glucose levels will be measured three times per day (morning, afternoon, evening) for 3 consecutive days, using a glucose meter. The average level for each day will be calculated.
Time frame: 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
Cortisol levels will be measured twice on Day 3, once before the intervention and once after the intervention, using a salivary cortisol test. Saliva samples will be collected and analyzed to assess changes in cortisol concentration, which serves as an indicator of stress.
Time frame: 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.
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