NCT07551401

Brief Summary

Cesarean section is a common surgical procedure performed to deliver a baby when vaginal birth may pose risks to the mother or infant. Although it is often life-saving, recovery after cesarean section is frequently associated with multiple physical and psychological challenges, including postoperative pain, delayed gastrointestinal function, reduced mobility, fatigue, and decreased overall well-being. These factors may negatively affect a woman's ability to care for her newborn, initiate breastfeeding, and adapt to the postpartum period. In recent years, there has been increasing interest in non-pharmacological interventions that can safely support postoperative recovery without causing additional side effects. Among these, music therapy, breathing exercises, and virtual reality applications have been identified as promising approaches. Music therapy may promote relaxation and reduce pain and anxiety through auditory stimulation and emotional regulation. Breathing exercises may enhance parasympathetic activity, improve oxygenation, reduce stress, and support gastrointestinal motility. Virtual reality applications, by providing immersive audiovisual experiences, may reduce pain perception, decrease anxiety, and improve overall comfort through distraction and relaxation mechanisms. Although these interventions have individually demonstrated beneficial effects in postoperative care, the existing literature is limited in directly comparing their relative effectiveness within the same study design. Furthermore, most studies have primarily focused on pain outcomes, while other important aspects of recovery, such as obstetric recovery quality and gastrointestinal symptoms, have received less attention. This randomized controlled trial aims to comparatively investigate the effects of music therapy, breathing exercises, and virtual reality application on obstetric recovery, pain, and gastrointestinal symptoms in women following cesarean section. Participants will be randomly assigned to one of three intervention groups or a control group receiving routine care. Standardized protocols will be applied for each intervention to ensure consistency. The primary outcomes of this study include obstetric recovery, pain intensity, and gastrointestinal symptoms. By evaluating these outcomes simultaneously, the study aims to provide a more comprehensive understanding of post-cesarean recovery. The findings of this study are expected to contribute to evidence-based clinical practice by identifying effective, safe, and feasible non-pharmacological interventions that can be integrated into routine post-cesarean care. Ultimately, this research may help improve maternal comfort, accelerate recovery, and enhance the overall postpartum experience for women undergoing cesarean section.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress2%
May 2026Mar 2027

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 18, 2026

Last Update Submit

April 26, 2026

Conditions

Keywords

Cesarean SectionObstetric RecoveryPostoperative PainGastrointestinal SymptomsMusic TherapyBreathing ExercisesVirtual RealityPostpartum Care

Outcome Measures

Primary Outcomes (3)

  • Obstetric Recovery (ObsQoR-11)

    Obstetric recovery will be assessed using the Obstetric Quality of Recovery Score-11 (ObsQoR-11), a validated patient-reported outcome measure evaluating physical comfort, emotional status, functional independence, and pain.

    At 4 and 12 hours postoperatively

  • Postoperative Pain (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from no pain to worst possible pain.

    At 4 and 12 hours postoperatively

  • Gastrointestinal Symptoms (GSRS)

    Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS), which assesses abdominal pain, reflux, diarrhea, indigestion, and constipation. Higher scores indicate more severe symptoms.

    At 4 and 12 hours postoperatively

Secondary Outcomes (1)

  • Time to First Flatus

    At 4 and 12 hours postoperatively

Study Arms (4)

Music Therapy Group

EXPERIMENTAL

Participants in this group will receive music therapy in addition to routine postoperative care. The intervention will be administered in two sessions at the 4th and 12th postoperative hours following cesarean section. Each session will last 20 minutes. Standardized music content will be delivered via wireless headphones in a quiet and controlled environment. Outcome measures will be assessed at the 4th and 12th postoperative hours.

Behavioral: Music Therapy

Breathing Exercises Group

EXPERIMENTAL

Participants in this group will perform guided breathing exercises in addition to routine postoperative care. The intervention will be conducted in two sessions at the 4th and 12th postoperative hours. Each session will last 20 minutes and will consist of slow, controlled breathing techniques under researcher supervision. Outcome measures will be assessed at the 4th and 12th postoperative hours.

Behavioral: Breathing Exercises

Virtual Reality Group

EXPERIMENTAL

Participants in this group will receive a virtual reality intervention in addition to routine postoperative care. The intervention will be applied in two sessions at the 4th and 12th postoperative hours. Each session will last 20 minutes and will involve standardized immersive audiovisual content delivered via a virtual reality headset in a controlled environment. Outcome measures will be assessed at the 4th and 12th postoperative hours.

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

Participants in this group will receive routine postoperative care according to hospital protocols without any additional intervention. Outcome measures will be assessed at the 4th and 12th postoperative hours.

Interventions

Music TherapyBEHAVIORAL

Participants will receive music therapy using standardized audio content delivered through wireless headphones. The intervention will be applied in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes, in a quiet and controlled environment.

Music Therapy Group

Participants will perform guided breathing exercises under researcher supervision. The intervention will be conducted in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes, using slow and controlled breathing techniques.

Breathing Exercises Group
Virtual RealityBEHAVIORAL

Participants will receive a virtual reality intervention using a headset to view standardized immersive audiovisual content. The intervention will be applied in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes.

Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 years and older
  • Able to speak and understand Turkish
  • Gestational age between 37 and 42 weeks
  • Undergoing cesarean section under spinal anesthesia
  • Able to communicate and willing to participate
  • No major intraoperative or early postoperative complications (within 0-12 hours), such as severe hemorrhage (\>1000 mL), anesthesia-related cardiorespiratory complications, major surgical complications, wound dehiscence, sepsis, or need for intensive care
  • No visual or hearing impairments
  • Having a live, healthy, singleton newborn

You may not qualify if:

  • Passage of flatus before the intervention
  • Presence of any diagnosed medical condition during pregnancy
  • Development of maternal postpartum complications such as postpartum hemorrhage (\>1000 mL), infection, wound dehiscence, sepsis, thromboembolism, or need for intensive care
  • Presence of neonatal complications such as neonatal distress requiring intensive care, congenital anomalies, severe respiratory distress, infection, or perinatal mortality
  • History of chronic pain, gastrointestinal disease, or respiratory disease
  • Diagnosed and treated psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Music TherapyBreathing Exercises

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Sureyya Kilic, Specialist Midwife

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions (music therapy, breathing exercises, and virtual reality), participants and intervention providers cannot be blinded. However, outcome assessment will be conducted using standardized measurement tools. Data analysis will be performed by an independent statistician who will be blinded to group allocation. Group assignments will be coded (e.g., Group A, B, C, D) to ensure blinding during statistical analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1:1:1 ratio to one of four parallel groups: music therapy, breathing exercises, virtual reality, or routine care control. Randomization will be performed using stratified block randomization according to parity (primiparous/multiparous) and education level (primary, secondary, higher education) to ensure baseline balance across groups. Outcome assessments will be conducted at postoperative 4th and 12th hours using a pretest-posttest design. Each participant will receive only the intervention assigned to her group, and no crossover between groups will occur.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations