Postoperative Music for Orbital Decompression

NCT ID: NCT04933201

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Surgery Pain Musth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Music group

Perioperative music intervention

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Perioperative musical intervention

Control group

No perioperative music

Group Type ACTIVE_COMPARATOR

Routine perioperative treatment

Intervention Type OTHER

Routine perioperative treatment

Interventions

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Music

Perioperative musical intervention

Intervention Type OTHER

Routine perioperative treatment

Routine perioperative treatment

Intervention Type OTHER

Other Intervention Names

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Routine perioperative treatment without music

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huijing Ye

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huijing Ye

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huijing Ye

Role: CONTACT

+00862087331539

Huasheng Yang

Role: CONTACT

+00862087331539

Facility Contacts

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Huijing Ye, Doctor

Role: primary

00862087331539

Huasheng Yang, Doctor

Role: backup

00862087331539

Other Identifiers

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202105

Identifier Type: -

Identifier Source: org_study_id

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