Gestational Diabetes Mellitus in PregnancyNCT06970886
Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes
A study testing Rhythm-Based Music Intervention in people with Gestational Diabetes Mellitus in Pregnancy and Anxiety, run by Esin Ceber Turfan, Professor at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Anxiety, Blood Sugar; High
- What is being tested?
- Rhythm-Based Music Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 25 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İzmir City Hospital
Izmir, 35000
Atalay Ekin, Prof, +905357410380, atalay.ekin@sbu.edu.tr
Esin Ceber Turfan, Prof, +905369662353, esin.ceber@ege.edu.tr
About this study
Official title: Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Rhythm-Based Music Intervention
- Keywords
- Anxiety, Blood glucose, Gestational diabetes, Salivary cortisol
- Medical subject headings
- Anxiety Disorders, Hyperglycemia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm-Based Music InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 per day (morning, afternoon, evening) for 3 consecutive days, using a glucose meter. The average level for each day will be calculated.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion5 Sep 2026 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esin Ceber Turfan, Professor
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Sponsor-investigator, Esin Ceber Turfan, Professor, Ege University
- Investigators
- Esin Ceber Turfan, Prof, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970886
- Sponsor's protocol ID
- EgeUTYilmaz001
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including outcome measures such as anxiety scores, blood glucose levels, and salivary cortisol levels, will be shared upon reasonable request. Data will be available after publication for qualified researchers conducting academic studies. Access to the data will require approval by the principal investigator.
Publications
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047Adhikari 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.
PubMed 32056477E 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.
PubMed 39031663Alakidi 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.
PubMed 36710477Algül 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.
PubMed 40030101Baltaci 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.
PubMed 37010820Blair 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.
PubMed 28375882Castro-Quintas A, Eixarch E, Martin-Gonzalez NS, Daura-Corral M, Marques-Feixa L, Palma-Gudiel H, Rocavert-Barranco M, Miguel-Valero A, Monteserin-Garcia JL, de la Fuente-Tomas L, Crispi F, Arias B, Garcia-Portilla MP, Fananas L. Diurnal cortisol throughout pregnancy and its association with maternal depressive symptoms and birth outcomes. Psychoneuroendocrinology. 2024 Mar;161:106930. doi: 10.1016/j.psyneuen.2023.106930. Epub 2023 Dec 19.
PubMed 38142606Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs. 2008 Oct;17(19):2580-7. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19.
PubMed 18298503Chang SC, Chen CH. Effects of music therapy on women's physiologic measures, anxiety, and satisfaction during cesarean delivery. Res Nurs Health. 2005 Dec;28(6):453-61. doi: 10.1002/nur.20102.
PubMed 16287051Correia KF, Dodge LE, Farland LV, Hacker MR, Ginsburg E, Whitcomb BW, Wise LA, Missmer SA. Confounding and effect measure modification in reproductive medicine research. Hum Reprod. 2020 May 1;35(5):1013-1018. doi: 10.1093/humrep/deaa051.
PubMed 32424412Catalgol S, Ceber Turfan E. The effects of music therapy applied to pregnant women on maternal, fetal, and neonatal results: A randomized controlled study. Health Care Women Int. 2022 May;43(5):448-464. doi: 10.1080/07399332.2021.1944150. Epub 2021 Aug 3.
PubMed 34344266Devecioğlu F. Müzik Eserlerinde Tempo Terimi ve Metronom Değerlerinin Önemi ve Belirtilmemesinin Oluşturduğu Sorunlar. Akü Amader. 2023; 9(17): 86-143.
Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14.
PubMed 34464836
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06970886
- Acronym / sponsor ID
- EgeUTYilmaz001
- Keywords
- Anxiety, Blood glucose, Gestational diabetes, Salivary cortisol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Esin Ceber Turfan, ProfessorUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhythm-Based Active Music Engagement Group | Experimental | Behavioral: Rhythm-Based Music InterventionParticipants 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. |
| Rhythm-Based Music Listening Group | Experimental | Behavioral: Rhythm-Based Music InterventionParticipants 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. |
| Control Group | No intervention | –Participants in the control group will receive routine prenatal care without any additional music intervention during the study period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythm-Based Music InterventionThe 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. | Behavioural | Rhythm-Based Active Music Engagement Group, Rhythm-Based Music Listening Group |
Primary outcome
Anxiety Levels
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.
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.
2 secondary outcomes
Blood Glucose Levels
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Background: PubMed 32056477Adhikari 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.
- Background: PubMed 39031663E 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.
- Background: PubMed 36710477Alakidi 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.
- BackgroundAlgül 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
- Background: PubMed 40030101Aydemir 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.
- Background: PubMed 37010820Baltaci 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.
- Background: PubMed 28375882Blair 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.
- Background: PubMed 38142606Castro-Quintas A, Eixarch E, Martin-Gonzalez NS, Daura-Corral M, Marques-Feixa L, Palma-Gudiel H, Rocavert-Barranco M, Miguel-Valero A, Monteserin-Garcia JL, de la Fuente-Tomas L, Crispi F, Arias B, Garcia-Portilla MP, Fananas L. Diurnal cortisol throughout pregnancy and its association with maternal depressive symptoms and birth outcomes. Psychoneuroendocrinology. 2024 Mar;161:106930. doi: 10.1016/j.psyneuen.2023.106930. Epub 2023 Dec 19.
- Background: PubMed 18298503Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs. 2008 Oct;17(19):2580-7. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19.
- Background: PubMed 16287051Chang SC, Chen CH. Effects of music therapy on women's physiologic measures, anxiety, and satisfaction during cesarean delivery. Res Nurs Health. 2005 Dec;28(6):453-61. doi: 10.1002/nur.20102.
- Background: PubMed 32424412Correia KF, Dodge LE, Farland LV, Hacker MR, Ginsburg E, Whitcomb BW, Wise LA, Missmer SA. Confounding and effect measure modification in reproductive medicine research. Hum Reprod. 2020 May 1;35(5):1013-1018. doi: 10.1093/humrep/deaa051.
- T.C. Strateji ve Bütçe Başkanlığı. "On İkinci Kalkınma Planı (2024-2028)".Link provided by the sponsor.
- WHO guide for integration of perinatal mental health in maternal and child health services.Link provided by the sponsor.
- WHO Traditional Medicine Strategy: 2014-2023.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including outcome measures such as anxiety scores, blood glucose levels, and salivary cortisol levels, will be shared upon reasonable request. Data will be available after publication for qualified researchers conducting academic studies. Access to the data will require approval by the principal investigator.
Related trials for Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esin Ceber Turfan, Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythm-Based Music Intervention in people with Gestational Diabetes Mellitus in Pregnancy and Anxiety, run by Esin Ceber Turfan, Professor at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Yilmaz, MSc (+905356790850, tugbayilmaz101@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Levels (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06970886, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.