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Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction

Primary Purpose

Music, Pain, Anxiety

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Music listening
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Music

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Pain score
Difference of Pain score before and after surgery

Secondary Outcome Measures

Change in Analgesia usage
Analgesia usage before and after surgery
Change in Patient's satisfaction with the use of music listening
Patient's satisfaction on music listening before and after surgery
Change in Hospital Anxiety and Depression Scale (HADS) score
HADS Anxiety and Depression score before and after surgery
Change in EQ-5D-3L score
EQ-5D-3L score before and after surgery

Full Information

First Posted
July 18, 2017
Last Updated
January 10, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03226028
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music, Pain, Anxiety, Patient Satisfaction, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Music listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain score
Description
Difference of Pain score before and after surgery
Time Frame
Baseline and 1 day
Secondary Outcome Measure Information:
Title
Change in Analgesia usage
Description
Analgesia usage before and after surgery
Time Frame
Baseline and 1 day
Title
Change in Patient's satisfaction with the use of music listening
Description
Patient's satisfaction on music listening before and after surgery
Time Frame
Baseline and 1 day
Title
Change in Hospital Anxiety and Depression Scale (HADS) score
Description
HADS Anxiety and Depression score before and after surgery
Time Frame
Baseline and 1 day
Title
Change in EQ-5D-3L score
Description
EQ-5D-3L score before and after surgery
Time Frame
Baseline and 1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females undergoing gynecologic surgery in KKH will be recruited.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, MBBS, MMED
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32089677
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7029289/
Description
The Effect of Perioperative Music Listening on Patient Satisfaction, Anxiety, and Depression: A Quasiexperimental Study

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Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction

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