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Postoperative Music for Orbital Decompression

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933201
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18.5
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Music
  • Other: Routine perioperative treatment
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Music for Postoperative Pain and Discomfort After Orbital Decompression
Actual Study Start Date :
Jun 16, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain after orbital decompression [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).

    Secondary Outcome Measures

    1. Discomfort after orbital decompression [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huijing Ye, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04933201
    Other Study ID Numbers:
    • 202105
    First Posted:
    Jun 21, 2021
    Last Update Posted:
    Jun 21, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huijing Ye, Principal Investigator, Sun Yat-sen University
    postoperative pain
    postoperative discomfort
    general anesthesia

    Study Results

    No Results Posted as of Jun 21, 2021