Postoperative Music for Orbital Decompression

Not Applicable

• Conditions: Surgery; Musth; Pain
• Interventions: Other: Music; Other: Routine perioperative treatment

• Registration Number: NCT04933201
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study Start: 2021-06-16
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music group	Music	Perioperative music intervention
Control group	Routine perioperative treatment	No perioperative music

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China