Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy

Sponsor

Eun Kyung Choi (Other)

Overall Status

Completed

CT.gov ID

NCT05320783

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Recovery After General Anesthesia Post Operative Pain	Other: music Other: control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 16, 2019

Actual Primary Completion Date :

Jan 14, 2022

Actual Study Completion Date :

Mar 16, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recovery quality [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)
Postoperative pain [36 hours after surgery]
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eun kyung Choi	Daegu	Korea (the Republic Of)	Korea, Republic of	41944

Sponsors and Collaborators

Eun Kyung Choi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eun Kyung Choi, Professor, Yeungnam University College of Medicine

ClinicalTrials.gov Identifier:

NCT05320783

Other Study ID Numbers:

YUMC 2019-09-052

First Posted:

Apr 11, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Apr 11, 2022