Music Therapy in Procedural Sedation in the Emergency Department
Condition: Conscious Sedation Failure During Procedure
MeSH terms: Emergencies
Study type: Interventional

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. 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: 
      1. 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.

        2. 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.

        3. Study-Wide Number of Subjects- Maximum target enrollment for each group will be 30
           subjects, with a total of 60 subjects for project.

        4. 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.

        5. 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.

        6. 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.

        7. 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.
    

Intervention name(s): Classical music
Intervention type(s): Other
Intervention description(s): Classical music will be played over the headphones
Other intervention name(s): Intervention arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment