Effect of Music Therapy on Postoperative Health Outcomes

NCT ID: NCT04155528

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-12-01
• Study Completion Date: 2028-12-30

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.

Detailed Description

Aim: The study will investigate the effect of music therapy on acute postoperative pain and sleep quality among patients undergoing abdominal surgery. A randomized control trial design will be demonstrated to accomplish this study. A total sample of 60 cases who underwent general abdominal surgery will be recruited. The study will be carried on in general surgery wards in one of a University Hospitals in Riyadh city, KSA. Four tools will be used to collect the data: Socio-demographic and medical data sheet, Pain Numeric Rating Scale (PNRS) for pain, Insomnia Severity Index (ISI) and Opinions Questions Regarding music therapy. The intervention group will listen to the selected prerecorded music on individual CD players by using a headset for consecutive three days. Music therapy will be given for 30 minutes during day time; depends upon the analgesics peak action time to avoid the bias of the intervention. Once again, it will be played before bedtime.

Conditions

Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Naglaa Fathy Afifi Youssef

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Omar Kasule, Professor

Role: CONTACT

irb@pnu.edu.sa

+966548867916

Other Identifiers

19-0163

Identifier Type: -

Identifier Source: org_study_id