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

NCT ID: NCT03415620

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2026-12-31

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.

Conditions

Music; Pain; Anxiety; Patient Satisfaction; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music listening

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.

Group Type: EXPERIMENTAL

Music listening

Intervention Type: 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.

No Music Listening

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music listening

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ban Leong Sng, MBBS, MMED

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Ban Leong Sng, MBBS, MMED

Role: CONTACT

sng.ban.leong@singhealth.com.sg

+6563941081

Facility Contacts

Ban Leong Sng, MBBS, MMED

Role: primary

sng.ban.leong@singhealth.com.sg

+6563941081

References

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.

Reference Type: DERIVED

PMID: 37013499 (View on PubMed)

Other Identifiers

MT2017-01

Identifier Type: -

Identifier Source: org_study_id