NCT04155528

Brief Summary

Patients underwent surgical procedure experiences acute postoperative pain, but less than half report adequate postoperative pain relief. The poor management of pain after surgery is associated with inadequate sleep and poor mood. Music therapy is described as a non-pharmacological technique to accomplish individualized patient's goals for hospital treatment. Music has been used as a healing approach. In Saudi Arabia, there is a lack of evidence related to the effect of music therapy on pain and sleep among patients who underwent abdominal surgery. Studies are needed to address additional aspects of pain management and the promotion of sleep among Saudi adult postoperative people by using non-pharmacological modalities.

Trial Health

65
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Dec 2027

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

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
8.1 years until next milestone

Study Start

First participant enrolled

December 1, 2027

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

November 5, 2019

Last Update Submit

August 11, 2025

Conditions

Music Therapy

Keywords

Music therapyPainSleep qualityAbdominal surgery

Outcome Measures

Primary Outcomes (2)

  • Pain Numeric Rating Scale (PNRS)

    The Pain Visual Analogue Scale (VAS) is a standardized scale, which measures pain severity. The Pain Numeric Rating Scale (PNRS) is a numeric version of the VAS. The PNRS has a single 11-point numeric scale in which respondents select a number from 0 (no pain) to 10 (severe pain) that reflects their pain severity. The PNRS has a high test-retest reliability in both literate and illiterate patients (r = 0.96 \& 0.95, respectively). Therefore, the PNRS will be used in this study to assess the pain severity.

    3 days

  • Insomnia Severity Index (ISI)

    The ISI is a widely used scale to evaluate insomnia. It consists of seven items; each item has a score of (0-4), where zero indicates no disturbance and four indicates very severe disturbance. The scale score gives four categories: no insomnia = 0-7; sub-threshold insomnia = 8-14; moderate insomnia = 15-21; and severe insomnia = 22-28. The Arabic ISI has ascertained satisfactory validity and reliability with a Cronbach's alpha coefficient of 0.84.

    3 days

Secondary Outcomes (1)

  • Opinions Questions Regarding music therapy

    3 days

Study Arms (2)

Study group

EXPERIMENTAL

The intervention group will receive routine hospital care alongside 30 minutes of music therapy per day for three consecutive days. The music therapy will be initiated on the second day postoperatively. The assessment of baseline data and the music therapy will be applied at least three hours after analgesics administration.

Other: Music therapy

Control group

NO INTERVENTION

Patients in the control group will receive routine hospital care only.

Interventions

Music therapyOTHER

The intervention is listening to selected prerecorded music, specific Raga, on the individual CD player.

Study group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who will meet the following criteria will be eligible to participate in this study:
  • Adult patients, including both sexes and aged between18-60 years.
  • Had an abdominal surgery.
  • Give informed consent and are hemodynamically stabilized.
  • Willing to receive music therapy for three consecutive postoperative days by using Headset.

You may not qualify if:

  • Patients will be ineligible to participate in this study if they have any of the following:
  • Hearing deficit.
  • History of chronic pain.
  • Metastasis cancer, on narcotic medication.
  • Dementia, or psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainSleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Omar Kasule, Professor

CONTACT

+966548867916irb@pnu.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share