NCT03226028

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2017Dec 2026

Study Start

First participant enrolled

May 4, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

8.3 years

First QC Date

July 18, 2017

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain score

    Difference of Pain score before and after surgery

    Baseline and 1 day

Secondary Outcomes (4)

  • Change in Analgesia usage

    Baseline and 1 day

  • Change in Patient's satisfaction with the use of music listening

    Baseline and 1 day

  • Change in Hospital Anxiety and Depression Scale (HADS) score

    Baseline and 1 day

  • Change in EQ-5D-3L score

    Baseline and 1 day

Study Arms (1)

Music

EXPERIMENTAL

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

Interventions

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.

Music

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females undergoing gynecologic surgery in KKH will be recruited.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

PainAnxiety DisordersPatient SatisfactionAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehaviorPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Ban Leong Sng, MBBS, MMED

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant/ Head of Department, Women's Anaesthesia

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

May 4, 2017

Primary Completion

August 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations