Clinical trial NCT03226028: Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction
Official title: The Effect of Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_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: 2017-07-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The capacity of music to relieve pain has been used in many forms of medicines and has been proven to reduce anxiety, pain and need for analgesia in perioperative setting. However, music listening as an inexpensive and duplicable method has not been studied in the local context. The investigators hereby propose a prospective study to recruit women who undergo surgery to evaluate the effectiveness of music in pain relief and post-operative recovery in KKH; as well as the possibility of implementing music listening in perioperative setting.

The patients will be offered to listen to one out of several pre-determined lists of music of different genres before, and after surgery. Data including pain score, Hospital Anxiety and Depression Scale (HADS) score, EuroQol-Five Dimensions questionnaire-using Three Levels (EQ-5D-3L), vital signs, analgesia usage and patient satisfaction will be collected in the perioperative period. The collected data shall also be assessed if they are affected by the presence of music, duration of music listening, and the genre chosen by the patients.

The investigators believe that this study could help determine the clinical relevance of music for pain relief in local setting, which potentially could reduce patient pain and anxiety caused by surgery. This in turn could allow music listening to be adopted as a non-invasive pain relief intervention in local healthcare settings and further improve patient outcome with lower cost and greater convenience as well as safety.

Detailed description: Some tissue injury is unavoidable during surgery, but pain and anxiety are (nearly as often) also unavoidable in the perioperative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions such as opioid-based analgesia for over a century. However, non-pharmacological interventions - such as music - have also been shown to safe and cost-effective, to improve the overall patient experience, and improve outcomes across a variety of surgical settings. Music has been shown to decrease pain in the perioperative period, to reduce plasma, urine, and salivary cortisol levels, modulate the inflammatory response (natural killer lymphocytes), blood pressure, and heart rate.Additionally, anxiety scores and pain scores (measured using the visual analog scale (VAS)) have shown statistically significant reductions in the perioperative period, when music therapy was available.

From 1 April 2015 to 31 March 2016, there were 31,871 surgeries done in KK Women's and Children's Hospital (KKH). While music therapy in the hospital has been offered as a part of cognitive rehabilitation services or end of life care, there is little investigation found on its effect if used perioperatively in adult patients who undergo surgeries, especially in local setting. Based on the above rationale, the investigators shall therefore investigate the feasibility and practicability of deploying music listening in pain management in KKH, 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.

Eligibility criteria: Inclusion Criteria:

* Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems);
* Undergo day surgery or same-day-admission gynecologic surgery;
* 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;
* Obstetric patients.

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
timeFrame: Baseline and 1 day
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline and 1 day
measure: Change in EQ-5D-3L 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:
citation: Tan DJA, Polascik BA, Kee HM, Hui Lee AC, Sultana R, Kwan M, Raghunathan K, Belden CM, Sng BL. The Effect of Perioperative Music Listening on Patient Satisfaction, Anxiety, and Depression: A Quasiexperimental Study. Anesthesiol Res Pract. 2020 Feb 7;2020:3761398. doi: 10.1155/2020/3761398. eCollection 2020.