Perioperative Pain ManagementNCT06467747
The Efficacy of Music on Perioperative Pain Management
A study testing Music and Mute in people with Perioperative Pain Management, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Pain Management
- What is being tested?
- Music and Mute
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jul 2024to May 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 20 years old and younger than 80 years old
- male or female
- Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy)
- Ambulatory surgery
- American Society of Anesthesiologists (ASA) physical status I~III
Who cannot join
- Severe hearing impairment
- Severe pulmonary or cardiovascular disease
- Brain or central nervous system (CNS) disorder
- Long-term systemic steroid or daily morphine treatment
- Pregnant women
- Emergency surgery
- The absence of informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taichung, Not in USA, 427
Mei-Ling Shen, +886-921126960, a8301058@gmail.com
About this study
Official title: The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management
The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.
The main questions it aims to answer are:
Read more
Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.
Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.
- Conditions
- Perioperative Pain Management
- Being tested
- Music, Mute
- Keywords
- Music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music group: wear earphones to listen to music and receive standardized anesthesia protocol
MuteOther
Mute group: wear earphones without music and receive standardized anesthesia protocol
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Listen music with earphone Receives: Other: Music |
| Mute group | Placebo comparator | Keep mute under earphone Receives: Other: Mute |
| Control group | No intervention | As usual anesthesia care without earphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
To assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Higher scores indicate greater pain intensity.
Measured: 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.
Secondary outcomes (3)
Analgesic-frequency
Frequency of analgesic usage
Measured: 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Analgesic-total amount
Total amount of analgesic used
Measured: 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Post-operative nausea and vomiting (PONV)
Frequency of nausea and vomiting episodes
Measured: 1. While in the post-anesthesia care unit, for an average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start3 Jul 2024
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Pain ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sih-hua Chen, Taichung Tzu Chi Hospital
- Investigators
- Mei-Ling Shen, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467747
- Sponsor's protocol ID
- REC113-11
- Status last verified
- Aug 2024
- First submitted
- 12 Jun 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management
- ClinicalTrials.gov ID
- NCT06467747
- Acronym / sponsor ID
- REC113-11
- Conditions
- Perioperative Pain Management
- Keywords
- Music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Jun 2024 (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 goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.
The main questions it aims to answer are:
Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.
Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: MusicListen music with earphone |
| Mute group | Placebo comparator | Other: MuteKeep mute under earphone |
| Control group | No intervention | –As usual anesthesia care without earphones |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 20 years old and younger than 80 years old
- male or female
- Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy)
- Ambulatory surgery
- American Society of Anesthesiologists (ASA) physical status I~III
Key exclusion criteria (7 listed)
- Severe hearing impairment
- Severe pulmonary or cardiovascular disease
- Brain or central nervous system (CNS) disorder
- Long-term systemic steroid or daily morphine treatment
- Pregnant women
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 |
|---|---|---|
| MusicMusic group: wear earphones to listen to music and receive standardized anesthesia protocol | Other | Music group |
| MuteMute group: wear earphones without music and receive standardized anesthesia protocol | Other | Mute group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.
To assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Higher scores indicate greater pain intensity.
3 secondary outcomes
Analgesic-frequency
Time frame: 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Analgesic-total amount
Time frame: 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Post-operative nausea and vomiting (PONV)
Time frame: 1. While in the post-anesthesia care unit, for an average of 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Mei-Ling Shen principal investigator
Taichung Tzu Chi Hospital
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 Mute in people with Perioperative Pain Management, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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 9 Aug 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Ling Shen (+886-921126960, a8301058@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.). 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 9 Aug 2024.