Music Therapy in the Treatment of Perioperative Anxiety and Pain

NCT05263635 | Completed

• 1 other identifier: STUDY21110130
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A large number of adults who undergo surgery experience perioperative anxiety and pain. The current recommended approach to perioperative pain management is a multimodal approach including opioids. Evidence has demonstrated that the pharmacological management of pain and anxiety is often associated with side effects which limits patient satisfaction and their ability to be discharged from the hospital. Furthermore, it is established that perioperative level of pain is directly correlated to anxiety, depression, and catastrophizing and these are significant predictors for the level of postoperative pain, as well as at the hospital length of stay. Therefore, considerations have been given to the use of non-pharmaceutical complementary approaches to management of anxiety including pre and postoperative use of music. The benefits of music therapy on anxiety has been reported using several surgical models and conditions in adults (cancer, hysterectomy in cancer) and children, prior to surgery and after. The objective of this study is to investigate the effects of music interventions on anxiety and pain in adult populations undergoing diverse types of minor surgery indicate that music therapy significantly reduces both post operative anxiety and pain in adults receiving music interventions before, during, or after surgery.

Conditions

Pain, Post Operative; Anxiety; Opioid Use

Keywords

Post operative pain management; music therapy; Post-surgical quality of life; hernia repair surgery; ambulatory breast surgery; cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Efficacy of music therapy on reducing post-operative opioid requirement

  The primary endpoint will be to observe the change in opioid requirement in patients undergoing surgery using the current multimodal Enhanced Recovery After Surgery (ERAS) protocol. This is reported in the consumption of oral morphine mg equivalents (OME).

  Day of surgery up to 5 days post-operative

Secondary Outcomes (10)

• Pre-operative emotional distress related to anxiety

  Baseline, pre-surgery

• Post-operative change in emotional distress related to anxiety

  Day 1, 2, 3, 4, and 5 post-operative

• Pre-operative emotional distress related to depression

  Baseline, pre-surgery

• Post-operative change in emotional distress related to depression

  Day 1, 2, 3, 4, and 5 post-operative

• Pre-operative pain rating using the Pain Catastrophizing Scale

  Baseline, pre-surgery

Study Arms (2)

Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS)

EXPERIMENTAL

All participants will have complete Enhanced Recovery After Surgery (ERAS) standard of care. A preoperative music intervention will be played first in the preoperative holding area, a second music intervention played immediately following the induction of anesthesia in the operating room, and a third music intervention played in the recovery room when the patient is awake and responsive.

Other: Music therapy; Other: Standard of Care Enhanced Recovery After Surgery (ERAS)

Standard of Care Enhanced Recovery After Surgery (ERAS)

ACTIVE COMPARATOR

Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions.

Other: Standard of Care Enhanced Recovery After Surgery (ERAS)

Interventions

Music therapy OTHER

Music therapy will include music intervention based on recommendations from literature such as slow, flowing rhythm, approximately 60-80 beats/minute and played by string instruments, played with a volume of approximately 45 decibel and will be reviewed by qualified music therapists.

Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS)

Standard of Care Enhanced Recovery After Surgery (ERAS) OTHER

Patients will receive the standard of care treatment for surgery and post-operative pain management, following the Enhanced Recovery After Surgery (ERAS) protocol

Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS); Standard of Care Enhanced Recovery After Surgery (ERAS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-70, meeting the American Society of Anesthesiologists (ASA) physical status I, II, or III
• Admitted for a scheduled same-day surgery under general anesthesia with a single nerve block, including ambulatory breast surgery, laparoscopic cholecystectomy or laparoscopic hernia repair surgery

You may not qualify if:

• Music other than the intervention planned in the operating room
• ASA status IV
• Planned spinal anesthesia
• Major psychosocial disorders
• Persistent opioid use
• History of drug abuse or alcoholism
• Baseline PROMIS Anxiety score of less than 19 or greater than 35
• Subject is already receiving an alternative intervention for anxiety or pain (i.e aromatherapy, hypnosis, etc)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Shadyside Hospital Foundation: collaborator

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shiv K Goel, MD, PhD, MBA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Anesthesiologist, Principle Investigator

Model Details: Randomized single-blind, comparator controlled trial involving patients undergoing ambulatory breast surgery, laparoscopic cholecystectomy surgery, or laparoscopic hernia repair surgery that score ≥19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: May 5, 2022
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)