SurgeryNCT04933201
Postoperative Music for Orbital Decompression
A study testing Music and Routine perioperative treatment in people with Surgery and Pain, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- What is being tested?
- Music and Routine perioperative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-75 years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
Who cannot join
- any uncontrolled clinical problems
- orbital decompression under local anesthesia
- Reluctance to participate in clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510000
Huijing Ye, Doctor, 00862087331539, yehuijing@qq.com
Huasheng Yang, Doctor, 00862087331539, yanghs64@126.com
About this study
Official title: Music for Postoperative Pain and Discomfort After Orbital Decompression
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.
- Being tested
- Music, Routine perioperative treatment
- Keywords
- postoperative pain, postoperative discomfort, general anesthesia
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Perioperative musical intervention
Routine perioperative treatmentOther
Also called Routine perioperative treatment without music
Routine perioperative treatment
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Perioperative music intervention Receives: Other: Music |
| Control group | Active comparator | No perioperative music Receives: Other: Routine perioperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 24 hour after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start16 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijing Ye, Sun Yat-sen University
- Investigators
- Huijing Ye, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933201
- Sponsor's protocol ID
- 202105
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music for Postoperative Pain and Discomfort After Orbital Decompression
- ClinicalTrials.gov ID
- NCT04933201
- Acronym / sponsor ID
- 202105
- Keywords
- postoperative pain, postoperative discomfort, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: MusicPerioperative music intervention |
| Control group | Active comparator | Other: Routine perioperative treatmentNo perioperative music |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16-75 years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
Key exclusion criteria (3 listed)
- any uncontrolled clinical problems
- orbital decompression under local anesthesia
- Reluctance to participate in clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicPerioperative musical intervention | Other | Music group |
| Routine perioperative treatmentAlso: Routine perioperative treatment without musicRoutine perioperative treatment | Other | Control group |
Primary outcome
Pain after orbital decompression
Time frame: 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).
1 secondary outcome
Discomfort after orbital decompression
Time frame: 24 hour after recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huijing Ye principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Routine perioperative treatment in people with Surgery and Pain, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huijing Ye (+00862087331539, yehuijing@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after orbital decompression (time frame: 24 hour after recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.