Clinical trial NCT04155528: Effect of Music Therapy on Postoperative Health Outcomes
Official title: The Effect of Music Therapy on Acute Pain and Sleep Quality Among Patients Underwent Abdominal Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Music Therapy
Keywords: Music therapy
Pain
Sleep quality
Abdominal surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2019-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Numeric Rating Scale (PNRS)
timeFrame: 3 days
measure: Insomnia Severity Index (ISI)
timeFrame: 3 days
Secondary outcomes:
measure: Opinions Questions Regarding music therapy
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References: