Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy

April 6, 2022 updated by: Eun Kyung Choi

Effect on Music Therapy on Quality of Recovery and Postoperative Pain After Gynecological Laparoscopy

In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea (the Republic Of)
      • Daegu, Korea (the Republic Of), Korea, Republic of, 41944
        • Eun kyung Choi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status classification I and II,
  • undergoing gynecological laparoscopic surgery

Exclusion Criteria:

  • Any hearing impairment,
  • Known psychiatric or memory disorder
  • Alcohol or analgesics abuse
  • Inability to complete quesationnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: music intervention
Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume.
Other: music
Classical music pre-selected was started to the patients with individual comfortable volume.
Placebo Comparator: control
Headphone was placed on the each patients, but the music player was not started.
Other: control
music player was not started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery quality
Time Frame: At postoperative day, 1
Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor ~ 200; excellent quality of recovery)
At postoperative day, 1
Postoperative pain
Time Frame: 36 hours after surgery
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain
36 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eun Kyung Choi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUMC 2019-09-052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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