Postoperative Music for Orbital Decompression
Music for Postoperative Pain and Discomfort After Orbital Decompression
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable surgery
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedStudy Start
First participant enrolled
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 21, 2021
June 1, 2021
1.5 years
June 14, 2021
June 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Discomfort after orbital decompression
24 hour after recovery
Study Arms (2)
Music group
EXPERIMENTALPerioperative music intervention
Control group
ACTIVE COMPARATORNo perioperative music
Interventions
Routine perioperative treatment
Eligibility Criteria
You may qualify if:
- years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
You may not qualify if:
- any uncontrolled clinical problems
- orbital decompression under local anesthesia
- Reluctance to participate in clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huijing Ye
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2021
First Posted
June 21, 2021
Study Start
June 16, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
June 21, 2021
Record last verified: 2021-06