Music TherapyMToPOHONCT04155528
Effect of Music Therapy on Postoperative Health Outcomes
A study testing Music therapy in people with Music Therapy, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Music Therapy
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2027to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Music Therapy on Acute Pain and Sleep Quality Among Patients Underwent Abdominal Surgery: A Randomized Control Trial
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.
Read the 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
- Being tested
- Music therapy
- Keywords
- Music therapy, Pain, Sleep quality, Abdominal surgery
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
The intervention is listening to selected prerecorded music, specific Raga, on the individual CD player.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music therapy |
| Control group | No intervention | Patients in the control group will receive routine hospital care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 days
Secondary outcomes (1)
Opinions Questions Regarding music therapy
This section has questions related to the participants' perspective regarding benefit in listening to music therapy during postoperative period in terms of reducing pain and improving sleep quality. There will be five questions which will evaluate the effect of music therapy in reducing pain and promoting sleep. This Question will be asked only to the participants in the experimental group at the end of the data collection. The questions are open ended or with dichotomous response (Yes or No). The results will be presented as percentage or frequency. There is no high or low answer, the score just reflects the participant's opinion on music as a therapy for reduce pain and improve sleep condition.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Dec 2027 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Fathy Afifi Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155528
- Sponsor's protocol ID
- 19-0163
- Acronym
- MToPOHO
- Status last verified
- Aug 2025
- First submitted
- 5 Nov 2019
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Acute Pain and Sleep Quality Among Patients Underwent Abdominal Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04155528
- Acronym / sponsor ID
- MToPOHO / 19-0163
- Conditions
- Music Therapy
- Keywords
- Music therapy, Pain, Sleep quality, Abdominal surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Music therapyThe 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. |
| Control group | No intervention | –Patients in the control group will receive routine hospital care only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients will be ineligible to participate in this study if they have any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyThe intervention is listening to selected prerecorded music, specific Raga, on the individual CD player. | Other | Study group |
Primary outcome
Pain Numeric Rating Scale (PNRS)
Time frame: 3 days
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.
Insomnia Severity Index (ISI)
Time frame: 3 days
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.
1 secondary outcome
Opinions Questions Regarding music therapy
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Music Therapy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Kasule, Professor (+966548867916, irb@pnu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numeric Rating Scale (PNRS) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.