Clinical trial NCT03415620: Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction
Official title: The Use of Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction in Patients Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Music
Pain
Anxiety
Patient Satisfaction
Analgesia
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-30
Enrollment: 410
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The randomized controlled phase will recruit 110 parturients.
Primary purpose: TREATMENT

Brief summary: The use of music to relieve pain has been studied in many forms of medicines and has been proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music listening as an inexpensive and duplicable method has not been investigated and implemented in the local context. The investigators hereby propose a prospective study to recruit patients undergoing surgery to evaluate the effectiveness of music in pain relief and post-operative recovery; as well as the implementation and operational readiness of music listening.

Detailed description: Some tissue injury is often unavoidable during surgery, which leads to unavoidable pain and anxiety during the perioperative and post-operative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions. However, non-pharmacological interventions have also been shown to be safe and cost-effective, improve the overall patient experience, and improve outcomes across a variety of surgical settings.

Music has been shown to decrease perioperative pain and modulate the inflammatory response. Additionally, anxiety scores and pain scores have shown statistically significant reductions in the perioperative period, when music therapy was available. Currently only few studies investigate its effects during perioperative period especially in local setting. Thus, the investigators will investigate the feasibility and practicability of deploying music listening in KKH pain management and further determine the nature of the music (duration, genre) by fitting the local context in order to improve the patient outcome in perioperative settings.

Phase 1: A total of 300 patients will be offered to select from pre-determined lists of music of different genres or patient choice, before and after surgery. Hospital Anxiety and Depression Scale (HADS) score, pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be collected. Analysis of the type of music, duration of music listening, and the genre chosen will be analysed.

Phase 2: A hundred and ten women undergoing Caesarean delivery at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of experimental (music listening) and control (no music listening) groups. Pain and psychological assessments and demographic data collection will be conducted before surgery, and those allocated to experimental group will be asked to use music listening before, during and after surgery.

Eligibility criteria: Inclusion Criteria:

* Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems);
* Undergo day surgery, same-day-admission gynecologic surgery or cesarean section;
* No hearing impairment.

Exclusion Criteria:

* Patients with significant respiratory disease and obstructive sleep apnea;
* Patients who are unable to read and understand the hospital anxiety questionnaire.

Primary outcomes:
measure: Change in Pain score
timeFrame: Baseline and 1 day
Secondary outcomes:
measure: Change in Analgesia usage
timeFrame: Baseline and 1 day
measure: Change in Patient's satisfaction with the use of music listening (only music listening group)
timeFrame: Baseline and 1 day
measure: Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)
timeFrame: Baseline and 1 day
measure: Change in EQ-5D-3L score
timeFrame: Baseline and 1 day
measure: Change in Visual analog scale - anxiety (VAS-A) score
timeFrame: Baseline and 1 day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, MBBS, MMED
role: PRINCIPAL_INVESTIGATOR
References: