Back to resultsEffect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy
Primary Purpose
Quality of Recovery After General Anesthesia, Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
music
control
Sponsored by
About this trial
This is an interventional prevention trial for Quality of Recovery After General Anesthesia
Eligibility Criteria
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
Sites / Locations
- Eun kyung Choi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
music intervention
control
Arm Description
Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume.
Headphone was placed on the each patients, but the music player was not started.
Outcomes
Primary Outcome Measures
Recovery quality
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
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05320783
Brief Title
Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy
Official Title
Effect on Music Therapy on Quality of Recovery and Postoperative Pain After Gynecological Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun Kyung Choi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Recovery After General Anesthesia, Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music intervention
Arm Type
Active Comparator
Arm Description
Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Headphone was placed on the each patients, but the music player was not started.
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
Classical music pre-selected was started to the patients with individual comfortable volume.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
music player was not started.
Primary Outcome Measure Information:
Title
Recovery quality
Description
Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor ~ 200; excellent quality of recovery)
Time Frame
At postoperative day, 1
Title
Postoperative pain
Description
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain
Time Frame
36 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eun kyung Choi
City
Daegu
State/Province
Korea (the Republic Of)
ZIP/Postal Code
41944
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy
We'll reach out to this number within 24 hrs