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Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction

Primary Purpose

Music, Pain, Anxiety

Status
Recruiting
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, 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.

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music listening

No Music Listening

Arm Description

Phase 1: Before and after surgery, 300 patients will be offered an ipod with earphone, in which the ipod is equipped with saved playlist of different music genres to select from pre-determined lists of music of different genres or patient choice. Patient will choose the desired playlist and listen to the music for about 30 minutes. 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: One hundred and ten women undergoing Caesarean delivery assigned to experimental (music listening) group will listen to the music before, during and after surgery. Pain and psychological assessments and demographic data collection will be conducted before and after surgery.

Phase 2: Patients assigned to this group (n=55) will only have pain, psychological assessments and demographic data collection conducted before and after surgery.

Outcomes

Primary Outcome Measures

Change in Pain score
Difference of Pain score before and after surgery. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.

Secondary Outcome Measures

Change in Analgesia usage
Analgesia usage (name and dosage of pain medication) used before and after surgery
Change in Patient's satisfaction with the use of music listening (only music listening group)
Patient's satisfaction on music listening before and after surgery. Patient will be asked on their satisfaction level based on ordinal scale (Excellent, Good, Fair, Poor).
Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)
HADS Anxiety and Depression score before and after surgery. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
Change in EQ-5D-3L score
EQ-5D-3L score before and after surgery. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Change in Visual analog scale - anxiety (VAS-A) score
VAS-A score before and after surgery. A visual analogue scale depicting anxiety (VAS-A) comprises a 10 cm line will be administered, on which the participant marks her current degree of anxiety with the left end of the line being labelled "no anxiety" and the right end being labelled "maximum anxiety".

Full Information

First Posted
January 10, 2018
Last Updated
August 8, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03415620
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

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
Model Description
The randomized controlled phase will recruit 110 parturients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music listening
Arm Type
Experimental
Arm Description
Phase 1: Before and after surgery, 300 patients will be offered an ipod with earphone, in which the ipod is equipped with saved playlist of different music genres to select from pre-determined lists of music of different genres or patient choice. Patient will choose the desired playlist and listen to the music for about 30 minutes. 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: One hundred and ten women undergoing Caesarean delivery assigned to experimental (music listening) group will listen to the music before, during and after surgery. Pain and psychological assessments and demographic data collection will be conducted before and after surgery.
Arm Title
No Music Listening
Arm Type
No Intervention
Arm Description
Phase 2: Patients assigned to this group (n=55) will only have pain, psychological assessments and demographic data collection conducted before and after surgery.
Intervention Type
Procedure
Intervention Name(s)
Music listening
Intervention Description
Patient is given an ipod with earphone and with saved playlist of different music genres. Music listening session will be given for 30 minutes before, during 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. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
Time Frame
Baseline and 1 day
Secondary Outcome Measure Information:
Title
Change in Analgesia usage
Description
Analgesia usage (name and dosage of pain medication) used before and after surgery
Time Frame
Baseline and 1 day
Title
Change in Patient's satisfaction with the use of music listening (only music listening group)
Description
Patient's satisfaction on music listening before and after surgery. Patient will be asked on their satisfaction level based on ordinal scale (Excellent, Good, Fair, Poor).
Time Frame
Baseline and 1 day
Title
Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)
Description
HADS Anxiety and Depression score before and after surgery. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
Time Frame
Baseline and 1 day
Title
Change in EQ-5D-3L score
Description
EQ-5D-3L score before and after surgery. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Time Frame
Baseline and 1 day
Title
Change in Visual analog scale - anxiety (VAS-A) score
Description
VAS-A score before and after surgery. A visual analogue scale depicting anxiety (VAS-A) comprises a 10 cm line will be administered, on which the participant marks her current degree of anxiety with the left end of the line being labelled "no anxiety" and the right end being labelled "maximum anxiety".
Time Frame
Baseline and 1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females undergoing gynecologic surgery or cesarean section 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Leong Sng, MBBS, MMED
Phone
+6563941081
Email
sng.ban.leong@singhealth.com.sg
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, MBBS, MMED
Phone
+6563941081
Email
sng.ban.leong@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction

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