Sleep QualityNCT05602883
Music Therapy in the Threat of Premature Birth
A study testing music therapy in people with Sleep Quality and Premature Labor, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The scope of the study covers the effects of music therapy on risk perception levels and sleep quality in pregnant women hospitalized due to the diagnosis of premature birth threat. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Premature Labor, Risk-Taking
- What is being tested?
- music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being hospitalized with a diagnosis of premature birth threat,
- be able to speak Turkish,
- be able to communicate verbally and in writing,
- volunteering to participate in research
- single pregnancy,
- be between 18-45 years old
Who cannot join
- be deaf,
- using sleep-related medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Gynecology and Pediatrics Hospital
Istanbul, Istanbul, 34200
About this study
Official title: The Effect of Music Therapy on Risk Perception and Sleep Quality in Preterm Birth Threat
The scope of the study covers the effects of music therapy on risk perception levels and sleep quality in pregnant women hospitalized due to the diagnosis of premature birth threat.
Read the detailed description
Premature labor is an action accompanied by cervical effacement and dilatation with contractions that occur between the 20th and 37th weeks of pregnancy, occur 2 times in 10 minutes or 3-4 times in 30 minutes, and last at least 30 seconds. The threat of premature birth is 20-37. It is a condition in which uterine contractions are not accompanied by cervical effacement and dilatation between weeks of pregnancy. Premature birth is one of the main causes of perinatal mortality and morbidity.
Although the prevalence of threat of premature birth differs from society to society, it was determined as 17.3% in our country. There is no definitive cure for threat of premature birth. Measures and treatments are applied to reduce the risk of preterm birth. These are classified as bed rest, sedation, hydration and tocolytic agents. In addition, pregnant women should be kept under surveillance and followed in the hospital for the correct diagnosis and management of treatment. Being sick and being hospitalized affect the pregnant woman's life in various ways; It increases anxiety and can disrupt life balance. In high-risk pregnancies, the stress experienced due to maternal or fetal problems is higher than in normal pregnancies. Experiencing intense stress during pregnancy causes suppression of the immune system, decreased fetal birth weight and increased risk of preterm birth. Being aware of the stressors and using appropriate stress coping methods in high-risk pregnancy may provide better health outcomes for the mother and baby.
Relaxation exercises, breathing exercises, physical exercise, dreaming (catathymia), yoga, massage therapy, acupuncture, biological feedback, providing social support, music therapy, strengthening spirituality are effective coping methods in coping with the stress that occurs in high-risk pregnancy. Music, which is one of these methods, is frequently used by health professionals. Music therapy causes the release of endorphins and provides relaxation in the muscles, lowers blood pressure, decreases heart rate and respiratory rate, and positively affects the emotional state, improves maternal condition and creates a comfortable environment for the fetus. There are studies showing that music reduces anxiety, stress and pain during preterm labor, delivery and cesarean section. It is also an inexpensive, safe, and easy-to-learn method by health care professionals. In a study by Yang et al. (2009), the effect of music therapy in reducing anxiety for women on antepartum bed rest was investigated. It was determined that anxiety levels and physiological responses during bed rest in the intervention group were significantly reduced by music therapy. It was concluded that music can be a cheap and effective method to reduce anxiety in high-risk pregnancies. In the study of Liu et al. (2010) on music, it was determined that music can be used as a non-medical coping method in reducing labor pain and anxiety. Health professionals should encourage pregnant women to listen to relaxing music, determine the appropriate time for listening to music (while doing daily chores, listening to a relaxing and pleasant music while taking a warm shower, etc.), providing comfort and giving attention to music. One of the important factors in ensuring the comfort of pregnant women in the hospital is sleep. Sleep quality has been strongly associated with a person's quality of life. Sleep disturbance in pregnant women has also been associated with an increase in inflammatory and oxidative stress markers that indicate endothelial damage and metabolic status.
Changes in sleep quality are closely related to stress and anxiety. However, music therapy, which is one of the inexpensive, easily applicable and accessible, non-pharmacological coping methods, has not been studied in pregnant women diagnosed with premature birth threat. Therefore, the aim of this study is to determine the effect of music therapy on risk perception and sleep quality in pregnant women diagnosed with preterm birth threat.
- Conditions
- Sleep Quality, Premature Labor, Risk-Taking
- Being tested
- music therapy
- Keywords
- premature birth threat, sleep quality, risk perception
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Obstetric Labor, Premature, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyBehavioural
Music is played for 20 minutes to the pregnant woman who is hospitalized due to the threat of premature birth.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental: Experimental group Pregnant women in this group will listen to a music of their choice for 20 minutes before going to bed at night. Receives: Behavioral: music therapy |
| Control group | No intervention | Women in the control group will not be interfered with and will be followed in line with the routine follow-up protocol of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richard Campbell Sleep Quality Scale
The Richard Campbell Sleep Quality Scale is a 6-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.
Measured: 4 days
Risk Perception Scale in Pregnancy
The scale is a visual analog measuring tool. Just below each item on the scale is a 0-100 mm linear line with the words "no risk" and "extremely high risk". The total score of the scale; It is calculated by adding the scores for each of the nine items and dividing the obtained score by 9. The scale has no breakpoints. An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Model description
- While the experimental group will listen to music at night, Routine midwifery care will be applied to the control group.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasemin hamlacı başkaya, Sakarya University
- Investigators
- Yasemin Hamlacı Baskaya, Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602883
- Sponsor's protocol ID
- 29092022
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11.
PubMed 26361642Heaman MI, Gupton AL. Psychometric testing of the Perception of Pregnancy Risk Questionnaire. Res Nurs Health. 2009 Oct;32(5):493-503. doi: 10.1002/nur.20342.
PubMed 19606451Hansen IP, Langhorn L, Dreyer P. Effects of music during daytime rest in the intensive care unit. Nurs Crit Care. 2018 Jul;23(4):207-213. doi: 10.1111/nicc.12324. Epub 2017 Nov 20.
PubMed 29159864Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.
PubMed 22866189Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5.
PubMed 25029946Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.
PubMed 19713801Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.
PubMed 20492051
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Risk Perception and Sleep Quality in Preterm Birth Threat
- ClinicalTrials.gov ID
- NCT05602883
- Acronym / sponsor ID
- 29092022
- Conditions
- Sleep Quality, Premature Labor, Risk-Taking
- Keywords
- premature birth threat, sleep quality, risk perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 2 Nov 2022 (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.
The scope of the study covers the effects of music therapy on risk perception levels and sleep quality in pregnant women hospitalized due to the diagnosis of premature birth threat.
Detailed description
Premature labor is an action accompanied by cervical effacement and dilatation with contractions that occur between the 20th and 37th weeks of pregnancy, occur 2 times in 10 minutes or 3-4 times in 30 minutes, and last at least 30 seconds. The threat of premature birth is 20-37. It is a condition in which uterine contractions are not accompanied by cervical effacement and dilatation between weeks of pregnancy. Premature birth is one of the main causes of perinatal mortality and morbidity.
Although the prevalence of threat of premature birth differs from society to society, it was determined as 17.3% in our country. There is no definitive cure for threat of premature birth. Measures and treatments are applied to reduce the risk of preterm birth. These are classified as bed rest, sedation, hydration and tocolytic agents. In addition, pregnant women should be kept under surveillance and followed in the hospital for the correct diagnosis and management of treatment. Being sick and being hospitalized affect the pregnant woman's life in various ways; It increases anxiety and can disrupt life balance. In high-risk pregnancies, the stress experienced due to maternal or fetal problems is higher than in normal pregnancies. Experiencing intense stress during pregnancy causes suppression of the immune system, decreased fetal birth weight and increased risk of preterm birth. Being aware of the stressors and using appropriate stress coping methods in high-risk pregnancy may provide better health outcomes for the mother and baby.
Relaxation exercises, breathing exercises, physical exercise, dreaming (catathymia), yoga, massage therapy, acupuncture, biological feedback, providing social support, music therapy, strengthening spirituality are effective coping methods in coping with the stress that occurs in high-risk pregnancy. Music, which is one of these methods, is frequently used by health professionals. Music therapy causes the release of endorphins and provides relaxation in the muscles, lowers blood pressure, decreases heart rate and respiratory rate, and positively affects the emotional state, improves maternal condition and creates a comfortable environment for the fetus. There are studies showing that music reduces anxiety, stress and pain during preterm labor, delivery and cesarean section. It is also an inexpensive, safe, and easy-to-learn method by health care professionals. In a study by Yang et al. (2009), the effect of music therapy in reducing anxiety for women on antepartum bed rest was investigated. It was determined that anxiety levels and physiological responses during bed rest in the intervention group were significantly reduced by music therapy. It was concluded that music can be a cheap and effective method to reduce anxiety in high-risk pregnancies. In the study of Liu et al. (2010) on music, it was determined that music can be used as a non-medical coping method in reducing labor pain and anxiety. Health professionals should encourage pregnant women to listen to relaxing music, determine the appropriate time for listening to music (while doing daily chores, listening to a relaxing and pleasant music while taking a warm shower, etc.), providing comfort and giving attention to music. One of the important factors in ensuring the comfort of pregnant women in the hospital is sleep. Sleep quality has been strongly associated with a person's quality of life. Sleep disturbance in pregnant women has also been associated with an increase in inflammatory and oxidative stress markers that indicate endothelial damage and metabolic status.
Changes in sleep quality are closely related to stress and anxiety. However, music therapy, which is one of the inexpensive, easily applicable and accessible, non-pharmacological coping methods, has not been studied in pregnant women diagnosed with premature birth threat. Therefore, the aim of this study is to determine the effect of music therapy on risk perception and sleep quality in pregnant women diagnosed with preterm birth threat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- While the experimental group will listen to music at night, Routine midwifery care will be applied to the control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: music therapyExperimental: Experimental group Pregnant women in this group will listen to a music of their choice for 20 minutes before going to bed at night. |
| Control group | No intervention | –Women in the control group will not be interfered with and will be followed in line with the routine follow-up protocol of the clinic. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being hospitalized with a diagnosis of premature birth threat,
- be able to speak Turkish,
- be able to communicate verbally and in writing,
- volunteering to participate in research
- single pregnancy,
Key exclusion criteria (2 listed)
- be deaf,
- using sleep-related medication
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 |
|---|---|---|
| music therapyMusic is played for 20 minutes to the pregnant woman who is hospitalized due to the threat of premature birth. | Behavioural | Experimental group |
Primary outcome
Richard Campbell Sleep Quality Scale
Time frame: 4 days
The Richard Campbell Sleep Quality Scale is a 6-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.
Risk Perception Scale in Pregnancy
Time frame: 4 days
The scale is a visual analog measuring tool. Just below each item on the scale is a 0-100 mm linear line with the words "no risk" and "extremely high risk". The total score of the scale; It is calculated by adding the scores for each of the nine items and dividing the obtained score by 9. The scale has no breakpoints. An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 26361642Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11.
- Results publication: PubMed 19606451Heaman MI, Gupton AL. Psychometric testing of the Perception of Pregnancy Risk Questionnaire. Res Nurs Health. 2009 Oct;32(5):493-503. doi: 10.1002/nur.20342.
- Results publication: PubMed 29159864Hansen IP, Langhorn L, Dreyer P. Effects of music during daytime rest in the intensive care unit. Nurs Crit Care. 2018 Jul;23(4):207-213. doi: 10.1111/nicc.12324. Epub 2017 Nov 20.
- Results publication: PubMed 22866189Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.
- Results publication: PubMed 25029946Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5.
- Results publication: PubMed 19713801Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.
- Results publication: PubMed 20492051Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yasemin Hamlacı Baskaya study director
Sakarya 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 music therapy in people with Sleep Quality and Premature Labor, run by Sakarya University 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richard Campbell Sleep Quality Scale (time frame: 4 days). The study lists 2 primary outcomes in all. 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 NCT05602883, which also lists 7 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 4 Sep 2026.