Music Utilization in Sedation and Induction in Colonoscopy

NCT04468048 | Withdrawn

• 1 other identifier: 1309407-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Conscious sedation (CS) if often used in the field of gastroenterology to alleviate pain and discomfort with interventional procedures. Although CS is relatively safe, there is concern for the development of cardiopulmonary complications. Music has been shown in multiple studies to decrease anxiety and improve patient satisfaction following cardiac, pulmonary, and surgical procedures. This is a prospective single-blinded randomized control trial that will examine the effects of active music participation and music listening on patients undergoing colonoscopy through propofol use (monitored anesthesia) at The Brooklyn Hospital Center. The study will enroll patients who will undergo colonoscopy from November 2018 to April 2019 and randomize them to receive music or no music starting at the initial nursing evaluation in the pre-procedure area. We hypothesize that incorporating music during colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and post-operative complications.

Conditions

Colonoscopy

Keywords

Colonoscopy; Music; Propofol; Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Amount of sedation used

  Total dose of propofol will be calculated by the Anesthesiologist's team. The total dosage for each group will be compared using a t-test

  Duration of procedure

Secondary Outcomes (2)

• Anxiety levels and willingness to perform procedures

  Duration of procedure

• Effect of music in relation to level of trainee

  Duration of procedure

Study Arms (2)

Music

Subjects will put on headphones containing music from the album "Nada Himalaya" performed by S. G. Sachchidananda. The music will start playing 10 minutes before the colonoscopy procedure and will stop once subjects have woken up from sedation. Subjects will be instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.

Other: Music: "Nada Himalaya" performed by S. G. Sachchidananda

Control

Subjects will put on headphones, but there will be no music playing. Subjects are instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.

Interventions

Music: "Nada Himalaya" performed by S. G. Sachchidananda OTHER

Music: "Nada Himalaya" performed by S. G. Sachchidananda

Music

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include all individuals undergoing colonoscopies that consented to participating in the study. The study subjects will include the patients undergoing the procedure and the gastroenterology fellows performing the procedure.

You may qualify if:

• Anyone scheduled for in-patient colonoscopy
• Must be able to speak English, Spanish, or Polish

You may not qualify if:

• Hearing impairment
• Mentally challenged
• Previous resection of the colon
• Currently using narcotics or sedative medications
• If patient is unwilling to use headphones after consenting

Sponsors & Collaborators

• The Brooklyn Hospital Center: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

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Study Officials

• Krishna Gurram, MD

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

• Daryl Ramai, MD, MScBR

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

• Khoi Paul Dang-Ho

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

• Madhavi Reddy, MD

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

• Denzil Etienne, MD

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: July 13, 2020
• Study Start: January 30, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

US (1)