Healing Sounds for Pregnant Women: Sape' Dayak Music and Anxiety Reduction

NCT07078097 | Completed DMC

• 2 other identifiers: 470/II/KE.PE/2025HK.02.03/XLI/1802/2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. Anxiety levels will be measured before and after the music interventions using the Perinatal Anxiety Screening Scale (PASS).

Conditions

Anxiety

Keywords

pregnancy; anxiety; music therapy; lullabies; traditional music; mental health

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (2)

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.

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.

Other: Brahms' Lullaby Music Therapy

Interventions

Traditional Sape' Dayak Music Listening OTHER

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.

Intervention Group (IG): Traditional Sape' Dayak Music

Brahms' Lullaby Music Therapy OTHER

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.

Control Group (CG): Brahms' Lullaby Music Therapy

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: The eligibility criteria and exclusion criteria refer to "women" and "mother/maternal" terms. This study's eligibility is limited by biological sex (females who are pregnant).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ). 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.

You may not qualify if:

• Beyond the 40th week of pregnancy;
• Having mental illness that caused hallucinations or altered perception of reality;
• ). Having a twin pregnancy.

Sponsors & Collaborators

• Health Polytechnic of Palangka Raya: lead

Study Sites (1)

Midwifery clinics

Palangkaraya, Central Kalimantan, 73112, Indonesia

Location

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Erina Eka Hatini, Master

  Health Polytechnic of Palangkaraya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 22, 2025
• Study Start: February 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 4, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: De-identified IPD will be generally made available to qualified researchers within six months following the primary publication of the study's main results, and data access requests can be submitted from that point forward.
• Access Criteria: The main way that data will be shared is through a safe, limited-access data repository. We share data using an encrypted storage medium after getting permission.

Locations

ID (1)