Postoperative Music for Orbital Decompression

June 17, 2021 updated by: Huijing Ye, Sun Yat-sen University

Music for Postoperative Pain and Discomfort After Orbital Decompression

The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To investigate the effect of music to the postoperative pain and discomfort after orbital decompression under general anesthesia.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University

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

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16-75 years old
  • diagnosed as thyroid eye disease
  • bone removal orbital decompression under general anesthesia

Exclusion Criteria:

  • any uncontrolled clinical problems
  • orbital decompression under local anesthesia
  • Reluctance to participate in clinical trials

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music group
Perioperative music intervention
Other: Music
Perioperative musical intervention
Active Comparator: Control group
No perioperative music
Other: Routine perioperative treatment
Routine perioperative treatment
Other Names:
  • Routine perioperative treatment without music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain after orbital decompression
Time Frame: 24 hour after recovery
Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).
24 hour after recovery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort after orbital decompression
Time Frame: 24 hour after recovery
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.
24 hour after recovery

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Huijing Ye, Sun Yat-sen University

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)

June 16, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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