CClinicalTrials.gg
Status unknownNCT04933201Updated Jun 21, 2021

Postoperative Music for Orbital Decompression

An interventional study of Music and Routine perioperative treatment in Surgery, Pain and Musth, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-21.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Surgery
  • Pain
  • Musth

Keywords

  • postoperative pain
  • postoperative discomfort
  • general anesthesia
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • any uncontrolled clinical problems
  • orbital decompression under local anesthesia
  • Reluctance to participate in clinical trials
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Music group

    Perioperative music intervention

    Other: Music

  • Active comparator
    Control group

    No perioperative music

    Other: Routine perioperative treatment

Interventions

  • OtherMusic

    Perioperative musical intervention

  • OtherRoutine perioperative treatment

    Routine perioperative treatment

    Also known as: Routine perioperative treatment without music

06

What researchers measure

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).

    Time frame: 24 hour after recovery

Secondary outcomes

  1. 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.

    Time frame: 24 hour after recovery

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04933201
Lead sponsor
Sun Yat-sen University
Responsible party
Huijing Ye (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Jun 21, 2021
Start date
Jun 16, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 21, 2021

Study contacts

Huijing Ye
Contact
yehuijing@qq.com
+00862087331539
Huasheng Yang
Contact
yanghs64@126.com
+00862087331539
Huijing Ye
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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