Effect of Music Therapy on Postoperative Health Outcomes (MToPOHO)
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|ClinicalTrials.gov Identifier: NCT04155528|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Music Therapy||Other: Music therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Music Therapy on Acute Pain and Sleep Quality Among Patients Underwent Abdominal Surgery: A Randomized Control Trial|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: 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.
Other: Music therapy
The intervention is listening to selected prerecorded music, specific Raga, on the individual CD player.
No Intervention: Control group
Patients in the control group will receive routine hospital care only.
- 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.
- Opinions Questions Regarding music therapy [ Time Frame: 3 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155528
|Contact: Omar Kasule, Professoremail@example.com|