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NCT04933201 Clinical Trial

Postoperative Music for Orbital Decompression

Pain Clinical Trial

Official title:
Music for Postoperative Pain and Discomfort After Orbital Decompression

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04933201
Other study ID # 202105
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2021
Est. completion date December 31, 2022

Study information
Verified date June 2021
Source Sun Yat-sen University
Contact Huijing Ye
Phone +00862087331539
Email yehuijing@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Music
Perioperative musical intervention
• Routine perioperative treatment
Routine perioperative treatment

Locations
Country Name City State
China Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain after orbital decompression 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 Discomfort after orbital decompression 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
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