Quality of Recovery After General AnesthesiaNCT05320783
Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy
A study testing music in people with Quality of Recovery After General Anesthesia and Post Operative Pain, run by Eun Kyung Choi at 1 site in South Korea.
Trial summary
In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Quality of Recovery After General Anesthesia, Post Operative Pain
- What is being tested?
- music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2019to 16 Mar 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification I and II,
- undergoing gynecological laparoscopic surgery
Who cannot join
- Any hearing impairment,
- Known psychiatric or memory disorder
- Alcohol or analgesics abuse
- Inability to complete quesationnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Music Therapy on Quality of Recovery and Postoperative Pain After Gynecological Laparoscopy
In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.
- Being tested
- music, control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Classical music pre-selected was started to the patients with individual comfortable volume.
controlOther
music player was not started.
| Study group | Role | What they receive |
|---|---|---|
| music intervention | Active comparator | Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume. Receives: Other: music |
| control | Placebo comparator | Headphone was placed on the each patients, but the music player was not started. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery quality
Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor ~ 200; excellent quality of recovery)
Measured: At postoperative day, 1
Postoperative pain
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain
Measured: 36 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start16 Dec 2019
- Primary completion14 Jan 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Recovery After General AnesthesiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eun Kyung Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eun Kyung Choi, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320783
- Sponsor's protocol ID
- YUMC 2019-09-052
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Music Therapy on Quality of Recovery and Postoperative Pain After Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT05320783
- Acronym / sponsor ID
- YUMC 2019-09-052
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Eun Kyung ChoiUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 11 Apr 2022 (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.
In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music intervention | Active comparator | Other: musicHeadphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume. |
| control | Placebo comparator | Other: controlHeadphone was placed on the each patients, but the music player was not started. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status classification I and II,
- undergoing gynecological laparoscopic surgery
Key exclusion criteria (4 listed)
- Any hearing impairment,
- Known psychiatric or memory disorder
- Alcohol or analgesics abuse
- Inability to complete quesationnaires
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 |
|---|---|---|
| musicClassical music pre-selected was started to the patients with individual comfortable volume. | Other | music intervention |
| controlmusic player was not started. | Other | control |
Primary outcome
Recovery quality
Time frame: At postoperative day, 1
Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor ~ 200; excellent quality of recovery)
Postoperative pain
Time frame: 36 hours after surgery
Numeric rating scale (NRS, 0-10)O; no pain ~ 10; the most severe pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Quality of Recovery After General Anesthesia and Post Operative Pain, run by Eun Kyung Choi at 1 site in South Korea.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 11 Apr 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery quality (time frame: At postoperative day, 1). The study lists 2 primary outcomes in all. 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 11 Apr 2022.