Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery

NCT03486106 | Completed DMC

• 1 other identifier: HM20010566
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing.

Conditions

Anesthesia; Functional; Surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative propofol requirement

  The amount of propofol given in the operating room divided by duration of operating room time

  2 hours

Secondary Outcomes (2)

• Pain score

  24 hours

• Satisfaction score

  72 hours

Study Arms (2)

Headphones without music

PLACEBO COMPARATOR

Participants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. They will also receive propofol for sedation as needed.

Other: Headphones; Drug: Propofol

Headphones with music

EXPERIMENTAL

Participants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. They will also receive propofol for sedation as needed.

Other: Music; Other: Headphones; Drug: Propofol

Interventions

Music OTHER

Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection.

Headphones with music

Headphones OTHER

All participants will receive noise-cancelling wireless headphones that they will wear in the operating room during the procedure.

Headphones with music; Headphones without music

Propofol DRUG

All participants will receive intravenous doses of propofol; the timing and frequency of the doses will be given when the patient indicates (by squeezing a rubber duckie) that he/she wants sedation medication.

Headphones with music; Headphones without music

Eligibility Criteria

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

You may qualify if:

• undergoing a primary elective total knee replacement by Dr. Gregory Golladay (VCU surgeon and co-investigator for this research study)
• years of age or older
• eligible for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
• mentally capable of understanding instructions on how to request anesthesia medication
• mentally capable of understanding instructions on how to rate pain scores, anxiety level, and patient satisfaction

You may not qualify if:

• identified as a member of a regulated vulnerable population (one exception: limited English proficiency does not preclude them from this study; translation documents are available)
• ineligibility for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
• morbid obesity, BMI greater than 40
• allergy to propofol, midazolam, or morphine
• pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours
• hearing impaired individuals

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.

  PMID: 28619305 BACKGROUND

• Kahloul M, Mhamdi S, Nakhli MS, Sfeyhi AN, Azzaza M, Chaouch A, Naija W. Effects of music therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 Dec;12(1):1260886. doi: 10.1080/19932820.2017.1260886.

  PMID: 28452603 BACKGROUND

• Li J, Zhou L, Wang Y. The effects of music intervention on burn patients during treatment procedures: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2017 Mar 17;17(1):158. doi: 10.1186/s12906-017-1669-4.

  PMID: 28302117 BACKGROUND

• Alam M, Roongpisuthipong W, Kim NA, Goyal A, Swary JH, Brindise RT, Iyengar S, Pace N, West DP, Polavarapu M, Yoo S. Utility of recorded guided imagery and relaxing music in reducing patient pain and anxiety, and surgeon anxiety, during cutaneous surgical procedures: A single-blinded randomized controlled trial. J Am Acad Dermatol. 2016 Sep;75(3):585-589. doi: 10.1016/j.jaad.2016.02.1143. Epub 2016 Apr 25.

  PMID: 27125531 BACKGROUND

• Wang Y, Tang H, Guo Q, Liu J, Liu X, Luo J, Yang W. Effects of Intravenous Patient-Controlled Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A Randomized Parallel Study. J Altern Complement Med. 2015 Nov;21(11):667-72. doi: 10.1089/acm.2014.0310. Epub 2015 Sep 2.

  PMID: 26331434 BACKGROUND

MeSH Terms

Interventions

Music Therapy; Propofol

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Bryant Tran, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 3, 2018
• Study Start: July 13, 2018
• Primary Completion: July 12, 2019
• Study Completion: July 15, 2019
• Last Updated: May 25, 2023

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)