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

NCT03415620 | Recruiting DMC

• 1 other identifier: MT2017-01
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Music; Pain; Anxiety; Patient Satisfaction; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 day

Secondary Outcomes (5)

• Change in Analgesia usage

  Baseline and 1 day

• Change in Patient's satisfaction with the use of music listening (only music listening group)

  Baseline and 1 day

• Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)

  Baseline and 1 day

• Change in EQ-5D-3L score

  Baseline and 1 day

• Change in Visual analog scale - anxiety (VAS-A) score

  Baseline and 1 day

Study Arms (2)

Music listening

EXPERIMENTAL

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.

Procedure: Music listening

No Music Listening

NO INTERVENTION

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

Interventions

Music listening PROCEDURE

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.

Music listening

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Only females undergoing gynecologic surgery or cesarean section in KKH will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (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, same-day-admission gynecologic surgery or cesarean section;
• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

• Kakde A, Lim MJ, Shen H, Tan HS, Tan CW, Sultana R, Sng BL. Effect of music listening on perioperative anxiety, acute pain and pain catastrophizing in women undergoing elective cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Apr 3;23(1):109. doi: 10.1186/s12871-023-02060-w.

  PMID: 37013499 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ban Leong Sng, MBBS, MMED

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ban Leong Sng, MBBS, MMED

CONTACT

+6563941081; sng.ban.leong@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The randomized controlled phase will recruit 110 parturients.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 30, 2018
• Study Start: January 3, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)