Music Therapy for Post-cardiac Surgery Pain Management

Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy

Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use
• Intervention / Treatment: Other: Music Treatment

Detailed Description

2. Specific Aims:

1. Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used.

   Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.

2. Secondary Aims:

i. To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.

Hypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.

ii. To assess whether music therapy can increase patient satisfaction.

Hypothesis: Music therapy increases patient satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stanley Tam, MD; Phone Number: 617-789-2045; Email: stanley.tam@steward.org

Study Locations

• United States
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Steward St. Elizabeth Medical Center
      • Contact: Stanley Tam; Phone Number: 617-789-2045; Email: stanley.tam@steward.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

• Emergency cases.
• Patients with hearing impairment.
• Patients with dementia or other mental status changes.
• Patients who are clinically unstable postoperatively.
• Patients who develop postoperative complications.
• Patients who are non-English speaking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music treatment group; The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.	Other: Music Treatment; The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.
No Intervention: Control Group; No music treatment will be used. Standard pain and comfort measure only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of Opioid type pain medication used	To assess whether the use of music therapy can decrease the amount of opioid type pain medications used.	In the immediate post operative period, while patient still in the ICU

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Investigators: Principal Investigator: Stanley Tam, Steward St Elizabeth Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): September 21, 2023
• Study Completion (Anticipated): September 21, 2023

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 00770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No