NCT07786558

Brief Summary

This study aims to examine whether listening to live ukulele music after cesarean delivery can help reduce pain-related distress and anxiety and improve comfort in women who have given birth by cesarean section for the first time. Women participating in the study will be randomly assigned to either a ukulele music group or a routine care group. Women in the ukulele music group will listen to live ukulele music for 30 minutes at 24 hours after cesarean delivery. Women in the routine care group will receive the usual care provided by the hospital. The study will compare the two groups in terms of pain-related thoughts and distress, postpartum anxiety, and overall comfort during the early postpartum period. The findings may help determine whether live ukulele music can be used as a simple, non-drug approach to support women during recovery after cesarean delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 19, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Anxiety; Cesarean Delivery; Music Therapy; Pain; Postpartum Comfort; Ukulele

Outcome Measures

Primary Outcomes (3)

  • Pain Catastrophizing Level

    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-report instrument assessing rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing. The outcome will be compared between the ukulele music intervention group and the routine care control group.

    Between 25 and 26 hours postoperatively

  • Postpartum-Specific Anxiety Level

    Postpartum-specific anxiety will be assessed using the Turkish version of the Postpartum Specific Anxiety Scale (PSAS). The scale consists of 47 items rated on a 4-point Likert scale, with higher total scores indicating higher levels of postpartum-specific anxiety. The outcome will be compared between the ukulele music intervention group and the routine care control group.

    Between 25 and 26 hours postoperatively

  • Postpartum Comfort Level

    Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire (PPCQ), a 34-item instrument evaluating physical, psychospiritual, and sociocultural comfort. Total scores range from 34 to 170, with higher scores indicating higher levels of postpartum comfort. The outcome will be compared between the ukulele music intervention group and the routine care control group.

    Between 25 and 26 hours postoperatively

Study Arms (2)

Live Ukulele Music Group

EXPERIMENTAL

Participants assigned to this arm will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery. The same standardized melody will be performed live by the researcher in the participant's room. Room temperature and lighting will be adjusted according to the participant's preferences, and the ukulele sound level will be maintained between 70 and 73 dB throughout the intervention. Following the intervention, participants will complete assessments of pain catastrophizing, postpartum-specific anxiety, and postpartum comfort.

Behavioral: Live Ukulele Music

Routine Care Group

NO INTERVENTION

Participants assigned to this arm will receive the routine care and treatment provided by the clinical unit throughout the postoperative period, with no additional intervention during the study assessment period. The same outcome assessments will be administered at 25-26 hours after cesarean delivery. After completion of data collection, participants in the control group will be offered the same ukulele melody for 30 minutes as an ethical consideration.

Interventions

Women who were admitted to the postoperative unit and met the eligibility criteria were assessed by the researcher. Eligible women were provided with written and verbal information about the purpose of the study, the intervention procedures, ethical and institutional permissions, and the confidentiality of personal information. Written informed consent was obtained from women who agreed to participate in the study. Participants were assigned to the intervention and control groups in a 1:1 ratio using a computer-generated randomization sequence created with the RANDOM.ORG Sequence Generator (RANDOM.ORG, 2026). After the Informed Consent Form and Introductory Characteristics Questionnaire were administered to women assigned to the intervention group, the same standardized melody was performed live on the ukulele by the researcher for 30 minutes at 24 hours postoperatively. Following the intervention, the Postpartum Specific Anxiety Scale, Postpartum Comfort Scale, and Pain Catastrophizin

Live Ukulele Music Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who self-identify as female are eligible to participate in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous women who have undergone cesarean delivery under spinal anesthesia
  • No chronic disease
  • Turkish-speaking
  • Able to communicate effectively
  • Willing to participate voluntarily and provide written informed consent

You may not qualify if:

  • Hearing impairment
  • Cesarean delivery performed under epidural or general anesthesia
  • Development of postoperative complications
  • Requirement for additional analgesics beyond routine postoperative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either the ukulele music intervention group or the routine care control group. The intervention group will receive a 30-minute live ukulele music intervention at 24 hours after cesarean delivery, while the control group will receive routine postoperative care without an additional intervention during the study assessment period. Outcomes will be assessed after the intervention and compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assoc. Prof., Principal Investigator

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 26, 2026

Study Start

March 5, 2025

Primary Completion

September 1, 2025

Study Completion

September 5, 2025

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations