AnxietyNCT07078097
Healing Sounds for Pregnant Women: Sape' Dayak Music and Anxiety Reduction
A study testing Traditional Sape' Dayak Music Listening and Brahms' Lullaby Music Therapy in people with Anxiety, run by Health Polytechnic of Palangka Raya at 1 site in Indonesia.
Trial summary
This study investigates whether listening to traditional Dayak Sape' music could reduce anxiety in pregnant women as effectively as traditional lullabies. The researchers will recruit 32 pregnant women and divide them into two groups: one listened to Sape' Dayak music, and the other listened to Brahms' Lullaby. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Traditional Sape' Dayak Music Listening and Brahms' Lullaby Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2025to 4 May 2025
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1). Third trimester of pregnancy (28-40 weeks); 2). At least 20 years old; 3). Having a score on the Pittsburgh Sleep Quality Index (PSQI) score > 5, which indicates poor sleep quality; 3). Primiparous.
Who cannot join
- . Beyond the 40th week of pregnancy;
- . Having mental illness that caused hallucinations or altered perception of reality;
- 5). Having a twin pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Heritage of Healing: Traditional Song and Its Anxiety-Mitigating Effects During Pregnancy"
This study investigates whether listening to traditional Dayak Sape' music could reduce anxiety in pregnant women as effectively as traditional lullabies. The researchers will recruit 32 pregnant women and divide them into two groups: one listened to Sape' Dayak music, and the other listened to Brahms' Lullaby. Anxiety levels will be measured before and after the music interventions using the Perinatal Anxiety Screening Scale (PASS).
Read the detailed description
Pregnancy is a wonderful experience, but it can also be a source of anxiety for many women owing to hormonal changes, body changes, and the prospect of motherhood. This anxiety is not just uncomfortable; it can have a substantial influence on both the mother's and the baby's health. Recognizing this, experts are increasingly turning at non-medical approaches to aid, and music therapy is gaining popularity due to its low side effects.
Music has long been used for relaxation in various cultures, and it has been shown to have an effect on our physiology, including hormone release. This study will look specifically at the possibility of the Sape' Dayak, a traditional Indonesian instrument, as a therapeutic tool. The Sape' is noted for its relaxing properties and has a significant cultural value for the Dayak people. It is frequently utilized in healing rituals and community activities. While its cultural significance is evident, its specific benefit in relieving anxiety in pregnant women has not been extensively researched.
The primary purpose of this study is to address that research gap. The study is seeking to determine whether listening to Sape' Dayak music may reduce anxiety levels in pregnant mothers as effectively as traditional lullabies. The study intends to encourage holistic health practices while also contributing to the preservation of cultural heritage.
The study is designed as a quasi-experiment, with a control group. Researchers will recruit 32 pregnant women in the third trimester (28-40 weeks) from midwifery clinics. Participants require to be at least 18 years old, have poor sleep quality (a PSQI score of 5 or above). They will be eliminated if they are more than 40 weeks pregnant, have a mental disorder that affects their view of reality, or are carrying twins.
The 32 respondents will be split into two groups of sixteen each. One group, the intervention group (IG), will listen traditional Sape' Dayak music. The control group (CG) will listen to Brahms' Lullaby. Participants in both groups will be told to lightly massage their abdomens and visualize their infants while listening to music through earbuds for 20 minutes a day for three days straight. The music sessions will be held in the participants' homes to ensure privacy and comfort, with doors and windows closed.
Anxiety levels will be measured using the Perinatal Anxiety Screening Scale (PASS) both before (pre-test) and after the music intervention. The PASS is a solid and useful measure for identifying anxiety symptoms unique to perinatal women. The PASS scores assist characterize anxiety as little, mild-moderate, or severe. The acquired data will be examined using statistical software to assess anxiety levels across and within groups.
- Conditions
- Anxiety
- Being tested
- Traditional Sape' Dayak Music Listening, Brahms' Lullaby Music Therapy
- Keywords
- pregnancy, anxiety, music therapy, lullabies, traditional music, mental health
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Sape' Dayak Music ListeningOther
This intervention is distinguished by its use of the Sape' Dayak, a specific traditional musical instrument from East Kalimantan, Indonesia, known for its gentle, contemplative, and culturally significant sounds. The music utilizes pentatonic melodies that foster a serene and emotionally relaxing environment. Its distinct rhythm (80-85 beats per minute) is also a key feature. The intervention also incorporates a gentle abdominal massage and imagining the infant.
Brahms' Lullaby Music TherapyOther
This intervention is distinguished by its use of a globally popular and well-known lullaby composed by Johannes Brahms. The lyrics typically revolve around themes of love and affection, expressing mothers' love and tenderness for their fetuses. Unlike the Sape' Dayak, the specific lullaby will be preselected by the researcher to ensure a homogeneous intervention, with personal lullaby preferences ignored to avoid bias. Participants also engage in gentle abdominal touching and reflection on their unborn children.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG): Traditional Sape' Dayak Music | Experimental | Participants will listen to one Sape' Dayak song for 20 minutes daily over three consecutive days. This traditional Dayaknese song features pentatonic melodies known for creating a serene and emotionally relaxing environment, ideal for healing and anxiety relief. While listening through earphones, participants will be instructed to gently massage their abdomens and imagine their infants. The Sape' Dayak music has a slow rhythm, fluctuating between 80 to 85 beats per minute, which aligns with the normal heart rate. Sessions will be held in participants' homes for privacy, between 08:00 and 11:00 post-breakfast, ensuring no medical care or other distractions.
To ensure participants compliance, the trackify music tracking app will be used, and research assistants will collect the time of playing from the app upon completion of the session. Receives: Other: Traditional Sape' Dayak Music Listening |
| Control Group (CG): Brahms' Lullaby Music Therapy | Active comparator | Participants will listen to one preselected Johannes Brahms' Lullaby song for 20 minutes daily for three consecutive days. The lyrics typically express maternal love and tenderness for the fetus. Similar to the IG, participants will be instructed to gently touch their tummy and reflect on their unborn children while wearing earphones. The intervention will take place in their homes during the same morning hours, minimizing external influences. This standardized approach aims to avoid bias from personal music preferences.
To ensure participants compliance, the trackify music tracking app will be used, and research assistants will collect the time of playing from the app upon completion of the session. Receives: Other: Brahms' Lullaby Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Perinatal Anxiety Screening Scale (PASS)
The primary outcome measure is the level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS). This self-report instrument consists of 31 items, with participants rating subjective anxiety on a Likert scale from 0 (not at all) to 3 (very much). The PASS will be administered before and after the music intervention. It identifies anxiety symptoms specific to perinatal women and includes four subscales: acute anxiety and adjustment; general concern and specific fears; perfectionism, control, and trauma; and social anxiety. The total score is the sum of individual item scores. A cut-off score of 26 indicates clinically significant anxiety, with categories of minimal (0-20), mild-moderate (21-26), and severe (>26) anxiety. The PASS is validated and reliable in both English and Bahasa versions.
Measured: The anxiety levels of the participants will be assessed before the music intervention (pre-test) and after the music intervention (post-test). The post-test assessment will be conducted 20 minutes after the 3-day music intervention.
The level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS)
The primary outcome measure is the level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS). This self-report instrument consists of 31 items, with participants rating subjective anxiety on a Likert scale from 0 (not at all) to 3 (very much). The PASS will be administered before and after the music intervention. It identifies anxiety symptoms specific to perinatal women and includes four subscales: acute anxiety and adjustment; general concern and specific fears; perfectionism, control, and trauma; and social anxiety. The total score is the sum of individual item scores. A cut-off score of 26 indicates clinically significant anxiety, with categories of minimal (0-20), mild-moderate (21-26), and severe (>26) anxiety. The PASS is validated and reliable in both English and Bahasa versions.
Measured: The anxiety levels of the participants will be assessed before the music intervention (pre-test) and after the music intervention (post-test). The post-test assessment will be conducted 20 minutes after the 3-day music intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study used a quasi-experimental design with a control group, meaning participants were not randomly assigned. Instead, assignment was based on the midwifery clinic attended: clinic A for the Sape' Dayak intervention group (IG) and clinic B for the Brahms' Lullaby control group (CG). A pre-test and post-test design was used, with anxiety levels measured by the Perinatal Anxiety Screening Scale (PASS) before and after the intervention. The intervention involved 20 minutes of music listening daily for three consecutive days. This was conducted in participants' homes for comfort and privacy.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Polytechnic of Palangka Raya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erina Eka Hatini, Master, Principal investigator, Health Polytechnic of Palangkaraya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078097
- Sponsor's protocol ID
- 470/II/KE.PE/2025
- Other IDs
- HK.02.03/XLI/1802/2025
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study intended to share anonymized Individual Participant Data (IPD), which included raw and processed data for all main and secondary results, demographic details, and information on how well participants followed the intervention, with all personal identifiers taken out. In addition to the IPD, the final approved versions of the study protocol and the statistical analysis plan (SAP) were shared. Anonymized versions of the participant informed consent form (ICF), which were the data collection instruments, were also provided. Data was shared with qualified researchers involved in this study. The removal of identification meant that all direct identifiers, like names, addresses, phone numbers, and exact times of birth, enrolment, or assessment, were taken away for good. Each participant's data was given a unique, nameless code so that it could be tracked within the removed dataset without giving separate the participant's name.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Heritage of Healing: Traditional Song and Its Anxiety-Mitigating Effects During Pregnancy"
- ClinicalTrials.gov ID
- NCT07078097
- Acronym / sponsor ID
- 470/II/KE.PE/2025
- Conditions
- Anxiety
- Keywords
- pregnancy, anxiety, music therapy, lullabies, traditional music, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Health Polytechnic of Palangka RayaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 22 Jul 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 investigates whether listening to traditional Dayak Sape' music could reduce anxiety in pregnant women as effectively as traditional lullabies. The researchers will recruit 32 pregnant women and divide them into two groups: one listened to Sape' Dayak music, and the other listened to Brahms' Lullaby. Anxiety levels will be measured before and after the music interventions using the Perinatal Anxiety Screening Scale (PASS).
Detailed description
Pregnancy is a wonderful experience, but it can also be a source of anxiety for many women owing to hormonal changes, body changes, and the prospect of motherhood. This anxiety is not just uncomfortable; it can have a substantial influence on both the mother's and the baby's health. Recognizing this, experts are increasingly turning at non-medical approaches to aid, and music therapy is gaining popularity due to its low side effects.
Music has long been used for relaxation in various cultures, and it has been shown to have an effect on our physiology, including hormone release. This study will look specifically at the possibility of the Sape' Dayak, a traditional Indonesian instrument, as a therapeutic tool. The Sape' is noted for its relaxing properties and has a significant cultural value for the Dayak people. It is frequently utilized in healing rituals and community activities. While its cultural significance is evident, its specific benefit in relieving anxiety in pregnant women has not been extensively researched.
The primary purpose of this study is to address that research gap. The study is seeking to determine whether listening to Sape' Dayak music may reduce anxiety levels in pregnant mothers as effectively as traditional lullabies. The study intends to encourage holistic health practices while also contributing to the preservation of cultural heritage.
The study is designed as a quasi-experiment, with a control group. Researchers will recruit 32 pregnant women in the third trimester (28-40 weeks) from midwifery clinics. Participants require to be at least 18 years old, have poor sleep quality (a PSQI score of 5 or above). They will be eliminated if they are more than 40 weeks pregnant, have a mental disorder that affects their view of reality, or are carrying twins.
The 32 respondents will be split into two groups of sixteen each. One group, the intervention group (IG), will listen traditional Sape' Dayak music. The control group (CG) will listen to Brahms' Lullaby. Participants in both groups will be told to lightly massage their abdomens and visualize their infants while listening to music through earbuds for 20 minutes a day for three days straight. The music sessions will be held in the participants' homes to ensure privacy and comfort, with doors and windows closed.
Anxiety levels will be measured using the Perinatal Anxiety Screening Scale (PASS) both before (pre-test) and after the music intervention. The PASS is a solid and useful measure for identifying anxiety symptoms unique to perinatal women. The PASS scores assist characterize anxiety as little, mild-moderate, or severe. The acquired data will be examined using statistical software to assess anxiety levels across and within groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study used a quasi-experimental design with a control group, meaning participants were not randomly assigned. Instead, assignment was based on the midwifery clinic attended: clinic A for the Sape' Dayak intervention group (IG) and clinic B for the Brahms' Lullaby control group (CG). A pre-test and post-test design was used, with anxiety levels measured by the Perinatal Anxiety Screening Scale (PASS) before and after the intervention. The intervention involved 20 minutes of music listening daily for three consecutive days. This was conducted in participants' homes for comfort and privacy.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG): Traditional Sape' Dayak Music | Experimental | Other: Traditional Sape' Dayak Music ListeningParticipants will listen to one Sape' Dayak song for 20 minutes daily over three consecutive days. This traditional Dayaknese song features pentatonic melodies known for creating a serene and emotionally relaxing environment, ideal for healing and anxiety relief. While listening through earphones, participants will be instructed to gently massage their abdomens and imagine their infants. The Sape' Dayak music has a slow rhythm, fluctuating between 80 to 85 beats per minute, which aligns with the normal heart rate. Sessions will be held in participants' homes for privacy, between 08:00 and 11:00 post-breakfast, ensuring no medical care or other distractions. To ensure participants compliance, the trackify music tracking app will be used, and research assistants will collect the time of playing from the app upon completion of the session. |
| Control Group (CG): Brahms' Lullaby Music Therapy | Active comparator | Other: Brahms' Lullaby Music TherapyParticipants will listen to one preselected Johannes Brahms' Lullaby song for 20 minutes daily for three consecutive days. The lyrics typically express maternal love and tenderness for the fetus. Similar to the IG, participants will be instructed to gently touch their tummy and reflect on their unborn children while wearing earphones. The intervention will take place in their homes during the same morning hours, minimizing external influences. This standardized approach aims to avoid bias from personal music preferences. To ensure participants compliance, the trackify music tracking app will be used, and research assistants will collect the time of playing from the app upon completion of the session. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1). Third trimester of pregnancy (28-40 weeks); 2). At least 20 years old; 3). Having a score on the Pittsburgh Sleep Quality Index (PSQI) score > 5, which indicates poor sleep quality; 3). Primiparous.
Key exclusion criteria (3 listed)
- . Beyond the 40th week of pregnancy;
- . Having mental illness that caused hallucinations or altered perception of reality;
- 5). Having a twin pregnancy.
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 |
|---|---|---|
| Traditional Sape' Dayak Music ListeningThis intervention is distinguished by its use of the Sape' Dayak, a specific traditional musical instrument from East Kalimantan, Indonesia, known for its gentle, contemplative, and culturally significant sounds. The music utilizes pentatonic melodies that foster a serene and emotionally relaxing environment. Its distinct rhythm (80-85 beats per minute) is also a key feature. The intervention also incorporates a gentle abdominal massage and imagining the infant. | Other | Intervention Group (IG): Traditional Sape' Dayak Music |
| Brahms' Lullaby Music TherapyThis intervention is distinguished by its use of a globally popular and well-known lullaby composed by Johannes Brahms. The lyrics typically revolve around themes of love and affection, expressing mothers' love and tenderness for their fetuses. Unlike the Sape' Dayak, the specific lullaby will be preselected by the researcher to ensure a homogeneous intervention, with personal lullaby preferences ignored to avoid bias. Participants also engage in gentle abdominal touching and reflection on their unborn children. | Other | Control Group (CG): Brahms' Lullaby Music Therapy |
Primary outcome
The Perinatal Anxiety Screening Scale (PASS)
Time frame: The anxiety levels of the participants will be assessed before the music intervention (pre-test) and after the music intervention (post-test). The post-test assessment will be conducted 20 minutes after the 3-day music intervention.
The primary outcome measure is the level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS). This self-report instrument consists of 31 items, with participants rating subjective anxiety on a Likert scale from 0 (not at all) to 3 (very much). The PASS will be administered before and after the music intervention. It identifies anxiety symptoms specific to perinatal women and includes four subscales: acute anxiety and adjustment; general concern and specific fears; perfectionism, control, and trauma; and social anxiety. The total score is the sum of individual item scores. A cut-off score of 26 indicates clinically significant anxiety, with categories of minimal (0-20), mild-moderate (21-26), and severe (>26) anxiety. The PASS is validated and reliable in both English and Bahasa versions.
The level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS)
Time frame: The anxiety levels of the participants will be assessed before the music intervention (pre-test) and after the music intervention (post-test). The post-test assessment will be conducted 20 minutes after the 3-day music intervention.
The primary outcome measure is the level of anxiety in pregnant women, assessed using the Perinatal Anxiety Screening Scale (PASS). This self-report instrument consists of 31 items, with participants rating subjective anxiety on a Likert scale from 0 (not at all) to 3 (very much). The PASS will be administered before and after the music intervention. It identifies anxiety symptoms specific to perinatal women and includes four subscales: acute anxiety and adjustment; general concern and specific fears; perfectionism, control, and trauma; and social anxiety. The total score is the sum of individual item scores. A cut-off score of 26 indicates clinically significant anxiety, with categories of minimal (0-20), mild-moderate (21-26), and severe (>26) anxiety. The PASS is validated and reliable in both English and Bahasa versions.
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The study intended to share anonymized Individual Participant Data (IPD), which included raw and processed data for all main and secondary results, demographic details, and information on how well participants followed the intervention, with all personal identifiers taken out. In addition to the IPD, the final approved versions of the study protocol and the statistical analysis plan (SAP) were shared. Anonymized versions of the participant informed consent form (ICF), which were the data collection instruments, were also provided. Data was shared with qualified researchers involved in this study. The removal of identification meant that all direct identifiers, like names, addresses, phone numbers, and exact times of birth, enrolment, or assessment, were taken away for good. Each participant's data was given a unique, nameless code so that it could be tracked within the removed dataset without giving separate the participant's name.
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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.
Erina Eka Hatini, Master principal investigator
Health Polytechnic of Palangkaraya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Sape' Dayak Music Listening and Brahms' Lullaby Music Therapy in people with Anxiety, run by Health Polytechnic of Palangka Raya at 1 site in Indonesia.
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 1 inclusion and 3 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 22 Jul 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 Indonesia. 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?
The Perinatal Anxiety Screening Scale (PASS) (time frame: The anxiety levels of the participants will be assessed before the music intervention (pre-test) and after the music intervention (post-test). The post-test assessment will be conducted 20 minutes after the 3-day music intervention.). 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?
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 Jul 2025.