NCT05098561

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

5.9 years

First QC Date

September 18, 2021

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Music treatment group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No music treatment will be used. Standard pain and comfort measure only.

Interventions

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.

Music treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery via median sternotomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steward St. Elizabeth medical Center

Brighton, Massachusetts, 02135, United States

Location

Study Officials

  • Stanley Tam

    Steward St Elizabeth Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2021

First Posted

October 28, 2021

Study Start

October 15, 2018

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations