Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03226028
Collaborator
(none)
100
1
1
67.9
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Music listening
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction
Actual Study Start Date :
May 4, 2017
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music

The recruiter will give the patient an ipod with earphone, in which the ipod is equipped with saved playlists of different music genres. Patient will choose the desired playlists and listen to the music for about 30 minutes, seated in a quiet environment in pre-operative waiting area before her turn for the scheduled surgery. Hospital Anxiety and Depression Scale (HADS) and EQ-5D-3L questionnaire will be conducted during this period. Patient will be sent to the recovery room after the surgery, and will start the music listening again for 30 minutes once she is ready and feel comfortable to start the session. Pain score, HADS and EQ-5D-3L will be collected from the patient, as well as interview on her satisfaction and experience on the music listening.

Procedure: Music listening
Patient is given an ipod with earphone and with saved playlists of different music genres. Music listening session will be given for 30 minutes before and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain score [Baseline and 1 day]

    Difference of Pain score before and after surgery

Secondary Outcome Measures

  1. Change in Analgesia usage [Baseline and 1 day]

    Analgesia usage before and after surgery

  2. Change in Patient's satisfaction with the use of music listening [Baseline and 1 day]

    Patient's satisfaction on music listening before and after surgery

  3. Change in Hospital Anxiety and Depression Scale (HADS) score [Baseline and 1 day]

    HADS Anxiety and Depression score before and after surgery

  4. Change in EQ-5D-3L score [Baseline and 1 day]

    EQ-5D-3L score before and after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hospital Singapore Singapore 229899

Sponsors and Collaborators

  • KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Ban Leong Sng, MBBS, MMED, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sng Ban Leong, Senior Consultant/ Head of Department, Women's Anaesthesia, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT03226028
Other Study ID Numbers:
  • MT2017
First Posted:
Jul 21, 2017
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022