Conscious Sedation Failure During ProcedureNCT02676206
Music Therapy in Procedural Sedation in the Emergency Department
A study testing Classical music in people with Conscious Sedation Failure During Procedure, run by University of New Mexico at 1 site in United States.
Trial summary
The investigators propose to determine whether listening to classical music during a sedation procedure decreases the need for procedural sedation medication. It is a two arm study comparing music vs no music by headphones so that the investigator is blinded to the intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation Failure During Procedure
- What is being tested?
- Classical music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient in the UNMH ED between age 18-65
- An upper extremity (defined as distal to humerus, including humerus) or lower extremity fracture (defined as distal to femur, including femur)
- A closed fracture
- Undergoing procedural sedation for reduction of the fracture in the emergency department.
Who cannot join
- Clinically intoxicated
- Have dementia
- Experiencing psychosis
- Are deaf
- Patient who do not speak English
- Adults unable to consent
- Pregnant women
- Prisoners will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
The investigators propose to determine whether listening to classical music during a sedation procedure decreases the need for procedural sedation medication. It is a two arm study comparing music vs no music by headphones so that the investigator is blinded to the intervention. The outcome variable is amount of sedative used and self-reported anxiety level as reported on a 10 point visual analogue scale (VAS). The music intervention is begun 1 minute prior to the sedation procedure and continued until the subject is completely awake. Demographics will be collected for all patients. No identifiers are collected. Data will be compared for a change in VAS variable using non parametric methods.
Read the detailed description
- Objectives -The purpose of this study is to compare the amount of sedative (ketamine, propofol, ketofol, benzodiazepines, narcotics, or any other medications) used in procedural sedation of patients undergoing fracture reductions in the emergency department, as well as the amount of anxiety as measured by State-Trait Anxiety Inventory (STAI), in two groups: patients who listen to classical music during the procedure versus patients who do not listen to music during the procedure. The investigators hypothesize that patients who listen to classical music during procedural sedation will require lower amounts of sedatives and analgesia during the procedure and report lower levels of anxiety compared to patients who do not listen to classical music.
- Background- Music has been used to reduce anxiety and the experience of pain during medical procedures and can reduce the requirements for sedation in particular procedures. One study looked at 100 patients who were undergoing interventional radiological procedures. After randomizing the participants in a 1:1 ratio, it was found that sedation was required in 42% of the patients in the music group compared to 60% of patients in the control group. Also, the mean dosage of midazolam was significantly less in the music group compared to the control group. This demonstrated a significant reduction in sedation requirements for patients who had self-selected music playing during interventional radiological procedures. Music effectively made the procedure safer by reducing the need for sedation and further contributed to the experience of the patient. Procedural sedation is used in the UNM Hospital (UNMH) Emergency Department (ED) on a regular basis to help patients tolerate orthopedic reductions of simple, closed fractures without needing to go through general anesthesia. This project is designed to use music therapy in an attempt to augment the effects of procedural sedation. Our investigation proposes to study whether music therapy as an adjunct to sedation decreases the amount of sedatives and analgesics used in orthopedic patients undergoing procedural sedation, and whether these patients report less anxiety by having music as an adjunct. Music therapy during procedures has been shown to be cost effective - it reduces patient sedation, procedural times, and number of staff members necessary to be present during procedures. Music therapy may also be effective in reducing anxiety in patients undergoing surgery with regional anesthesia: In a group of 80 patients assigned to an experimental and a control group, anxiety was significantly reduced in the experimental group who listened to music using headphones throughout the surgery. According to two systematic reviews, music therapy significantly improving pain scores, satisfaction scores, anxiety scores, heart rate, and arterial pressure.
- Study-Wide Number of Subjects- Maximum target enrollment for each group will be 30 subjects, with a total of 60 subjects for project.
- Study Timelines- In the experimental group, this music will be started 1 minute prior to conscious sedation and continued until the patient's sedation wears off and patient is again interactive with investigator. The study will take approximately 15 minutes of the patient's time, divided between time before the procedure and time after the procedure. The duration anticipated to enroll all study subjects is difficult to anticipate, as the UNMH ED receives as many as one conscious sedation patient a day and as few as one a week. However, the duration is anticipated to take less than two years. Once data collection has closed, it will take researchers no longer than one year to complete primary analysis.
- Study Endpoints -The study endpoint will be reached when a total of 60 patients (30 experimental group and 30 in the control group) have been enrolled. There are no primary or secondary safety endpoints as there is no medical procedure or drug involved in this study.
- Procedures Involved -Participants will be randomized into the intervention or control group. The intervention will be listening to a classical song. In the experimental group, this music will be started 1 minute prior to conscious sedation and continued until the patient's sedation wears off and patient is again interactive with investigator. The music will be played using an Apple™ IPOD player attached to headphones. During hours when study recruiters are available, all patients between 18-65 years of age presenting to the adult ED at UNMH and needing an orthopedic reduction with procedural sedation will be invited to participate. If a patient agrees to participate, a research associate will collect patient's background information (age, sex, type of fracture, location of fracture, etc.) and then administer the STAI scale. Subjects will be assigned to either the control or experimental group by flip of coin. Subjects will then undergo sedation and reduction, with research associate recording the doses of sedatives and analgesics used, at the times of push. Once patient returns to baseline, research associate will remove headphones and administer the STAI scale once again. Demographic information (age, sex, type of fracture, location of fracture, etc.), STAI scale scores, and the amount of sedatives and analgesics administered during the procedure. Please see data collection form attachment for a comprehensive list.
- Provisions to Monitor the Data to Ensure the Safety of Subjects- The investigators are creating a Data and Safety Monitoring Plan for this study as the study is considered more than minimal risk by the investigational review board (IRB). The plan consists of monitoring the study for any adverse events incurred from subjects' participation in the study. Dr. Steven Weiss (also in Emergency Medicine) will head the management team. Every 6 months the investigators will evaluate the progress of the study, address any adverse events and create a report of any findings. At the yearly IRB renewal the investigator will include this report with the progress report. The endpoint will be when all subjects are recruited in the study, anticipated to take 18-24 months.
- Being tested
- Classical music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical musicOther
Also called Intervention arm
Classical music will be played over the headphones
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | Subjects will have headphones placed on 1 minute prior to procedural sedation. Classical music will be played until the subject is fully awake. Receives: Other: Classical music |
| Non intervention | No intervention | Subjects will have headphones placed on 1 minute prior to procedural sedation. No music will be played. The headphones will be removed when the subject is fully awake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual analogue score
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Difference in STAI anxiety score before and after intervention
Measured: through study completion, an average of 1 year
Anxiety scale- pre and post
Measured: through study completion, an average of 1 year
Any positive finding on the Common Terminology Criteria for Adverse Events (CTCAEv4.0) psychiatric scale
Number of participants with treatment related adverse events as assessed by the 20 categories in the CTCAE v4.0 psychiatric scale.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Conscious Sedation Failure During ProcedureStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Ernst, MD, Principal investigator, UNM hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676206
- Sponsor's protocol ID
- 15-540
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2016
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kulkarni S, Johnson PC, Kettles S, Kasthuri RS. Music during interventional radiological procedures, effect on sedation, pain and anxiety: a randomised controlled trial. Br J Radiol. 2012 Aug;85(1016):1059-63. doi: 10.1259/bjr/71897605. Epub 2012 Mar 14.
PubMed 22422386DeLoach Walworth D. Procedural-support music therapy in the healthcare setting: a cost-effectiveness analysis. J Pediatr Nurs. 2005 Aug;20(4):276-84. doi: 10.1016/j.pedn.2005.02.016.
PubMed 16030507Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.
PubMed 24731896Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19.
PubMed 25139786Yinger OS, Gooding LF. A systematic review of music-based interventions for procedural support. J Music Ther. 2015 Spring;52(1):1-77. doi: 10.1093/jmt/thv004. Epub 2015 Apr 15.
PubMed 25878063
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy in Procedural Sedation in the Emergency Department
- ClinicalTrials.gov ID
- NCT02676206
- Acronym / sponsor ID
- 15-540
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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 investigators propose to determine whether listening to classical music during a sedation procedure decreases the need for procedural sedation medication. It is a two arm study comparing music vs no music by headphones so that the investigator is blinded to the intervention. The outcome variable is amount of sedative used and self-reported anxiety level as reported on a 10 point visual analogue scale (VAS). The music intervention is begun 1 minute prior to the sedation procedure and continued until the subject is completely awake. Demographics will be collected for all patients. No identifiers are collected. Data will be compared for a change in VAS variable using non parametric methods.
Detailed description
- Objectives -The purpose of this study is to compare the amount of sedative (ketamine, propofol, ketofol, benzodiazepines, narcotics, or any other medications) used in procedural sedation of patients undergoing fracture reductions in the emergency department, as well as the amount of anxiety as measured by State-Trait Anxiety Inventory (STAI), in two groups: patients who listen to classical music during the procedure versus patients who do not listen to music during the procedure. The investigators hypothesize that patients who listen to classical music during procedural sedation will require lower amounts of sedatives and analgesia during the procedure and report lower levels of anxiety compared to patients who do not listen to classical music.
- Background- Music has been used to reduce anxiety and the experience of pain during medical procedures and can reduce the requirements for sedation in particular procedures. One study looked at 100 patients who were undergoing interventional radiological procedures. After randomizing the participants in a 1:1 ratio, it was found that sedation was required in 42% of the patients in the music group compared to 60% of patients in the control group. Also, the mean dosage of midazolam was significantly less in the music group compared to the control group. This demonstrated a significant reduction in sedation requirements for patients who had self-selected music playing during interventional radiological procedures. Music effectively made the procedure safer by reducing the need for sedation and further contributed to the experience of the patient. Procedural sedation is used in the UNM Hospital (UNMH) Emergency Department (ED) on a regular basis to help patients tolerate orthopedic reductions of simple, closed fractures without needing to go through general anesthesia. This project is designed to use music therapy in an attempt to augment the effects of procedural sedation. Our investigation proposes to study whether music therapy as an adjunct to sedation decreases the amount of sedatives and analgesics used in orthopedic patients undergoing procedural sedation, and whether these patients report less anxiety by having music as an adjunct. Music therapy during procedures has been shown to be cost effective - it reduces patient sedation, procedural times, and number of staff members necessary to be present during procedures. Music therapy may also be effective in reducing anxiety in patients undergoing surgery with regional anesthesia: In a group of 80 patients assigned to an experimental and a control group, anxiety was significantly reduced in the experimental group who listened to music using headphones throughout the surgery. According to two systematic reviews, music therapy significantly improving pain scores, satisfaction scores, anxiety scores, heart rate, and arterial pressure.
- Study-Wide Number of Subjects- Maximum target enrollment for each group will be 30 subjects, with a total of 60 subjects for project.
- Study Timelines- In the experimental group, this music will be started 1 minute prior to conscious sedation and continued until the patient's sedation wears off and patient is again interactive with investigator. The study will take approximately 15 minutes of the patient's time, divided between time before the procedure and time after the procedure. The duration anticipated to enroll all study subjects is difficult to anticipate, as the UNMH ED receives as many as one conscious sedation patient a day and as few as one a week. However, the duration is anticipated to take less than two years. Once data collection has closed, it will take researchers no longer than one year to complete primary analysis.
- Study Endpoints -The study endpoint will be reached when a total of 60 patients (30 experimental group and 30 in the control group) have been enrolled. There are no primary or secondary safety endpoints as there is no medical procedure or drug involved in this study.
- Procedures Involved -Participants will be randomized into the intervention or control group. The intervention will be listening to a classical song. In the experimental group, this music will be started 1 minute prior to conscious sedation and continued until the patient's sedation wears off and patient is again interactive with investigator. The music will be played using an Apple™ IPOD player attached to headphones. During hours when study recruiters are available, all patients between 18-65 years of age presenting to the adult ED at UNMH and needing an orthopedic reduction with procedural sedation will be invited to participate. If a patient agrees to participate, a research associate will collect patient's background information (age, sex, type of fracture, location of fracture, etc.) and then administer the STAI scale. Subjects will be assigned to either the control or experimental group by flip of coin. Subjects will then undergo sedation and reduction, with research associate recording the doses of sedatives and analgesics used, at the times of push. Once patient returns to baseline, research associate will remove headphones and administer the STAI scale once again. Demographic information (age, sex, type of fracture, location of fracture, etc.), STAI scale scores, and the amount of sedatives and analgesics administered during the procedure. Please see data collection form attachment for a comprehensive list.
- Provisions to Monitor the Data to Ensure the Safety of Subjects- The investigators are creating a Data and Safety Monitoring Plan for this study as the study is considered more than minimal risk by the investigational review board (IRB). The plan consists of monitoring the study for any adverse events incurred from subjects' participation in the study. Dr. Steven Weiss (also in Emergency Medicine) will head the management team. Every 6 months the investigators will evaluate the progress of the study, address any adverse events and create a report of any findings. At the yearly IRB renewal the investigator will include this report with the progress report. The endpoint will be when all subjects are recruited in the study, anticipated to take 18-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Other: Classical musicSubjects will have headphones placed on 1 minute prior to procedural sedation. Classical music will be played until the subject is fully awake. |
| Non intervention | No intervention | –Subjects will have headphones placed on 1 minute prior to procedural sedation. No music will be played. The headphones will be removed when the subject is fully awake. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient in the UNMH ED between age 18-65
- An upper extremity (defined as distal to humerus, including humerus) or lower extremity fracture (defined as distal to femur, including femur)
- A closed fracture
- Undergoing procedural sedation for reduction of the fracture in the emergency department.
Key exclusion criteria (8 listed)
- Clinically intoxicated
- Have dementia
- Experiencing psychosis
- Are deaf
- Patient who do not speak English
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 |
|---|---|---|
| Classical musicAlso: Intervention armClassical music will be played over the headphones | Other | Music intervention |
Primary outcome
Change in Visual analogue score
Time frame: through study completion, an average of 1 year
3 secondary outcomes
Difference in STAI anxiety score before and after intervention
Time frame: through study completion, an average of 1 year
Anxiety scale- pre and post
Time frame: through study completion, an average of 1 year
Any positive finding on the Common Terminology Criteria for Adverse Events (CTCAEv4.0) psychiatric scale
Time frame: through study completion, an average of 1 year
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 24 Jul 2023.
- Background: PubMed 22422386Kulkarni S, Johnson PC, Kettles S, Kasthuri RS. Music during interventional radiological procedures, effect on sedation, pain and anxiety: a randomised controlled trial. Br J Radiol. 2012 Aug;85(1016):1059-63. doi: 10.1259/bjr/71897605. Epub 2012 Mar 14.
- Background: PubMed 16030507DeLoach Walworth D. Procedural-support music therapy in the healthcare setting: a cost-effectiveness analysis. J Pediatr Nurs. 2005 Aug;20(4):276-84. doi: 10.1016/j.pedn.2005.02.016.
- Background: PubMed 24731896Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.
- Background: PubMed 25139786Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19.
- Background: PubMed 25878063Yinger OS, Gooding LF. A systematic review of music-based interventions for procedural support. J Music Ther. 2015 Spring;52(1):1-77. doi: 10.1093/jmt/thv004. Epub 2015 Apr 15.
- 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.
Amy Ernst, MD principal investigator
UNM 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 Classical music in people with Conscious Sedation Failure During Procedure, run by University of New Mexico at 1 site in United States.
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 4 inclusion and 8 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 24 Jul 2023. 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 United States. 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?
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?
Change in Visual analogue score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676206, which also lists 5 linked publications.
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 24 Jul 2023.