Role of Music Listening in Gastrointestinal Endoscopy

Application of Music Listening in Gastrointestinal Endoscopic Procedures

Gastrointestinal endoscopy is widely acknowledged as the most useful tool for diagnosing and treating gastrointestinal mucosal lesions. It can not only observe the mucosa directly, but also obtain tissue biopsy for pathological diagnosis. Although the importance of gastrointestinal endoscopy has been well understood, there are still a certain proportion of people who are unwilling to undergo it due to the discomfort and anxiety during the procedures. Music is multifunctional, which can alleviate people's depression, anxiety and other negative emotions as well as help to maintain good mental health. Thus, in this study we aim to investigate the role of music listening in gastrointestinal endoscopy in a randomized controlled clinical trial, especially for those patients who plan to undergo therapeutic endoscopic procedures and try to improve the patients' experience.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Endoscopic Procedures
• Intervention / Treatment: Behavioral: Music listening

Detailed Description

This is a randomized controlled trial to examine the function of music listening in the procedures of gastrointestinal endoscopy. It was previously reported that music listening may exert beneficial effects for patients who undergo gastrointestinal endoscopy. However, most of the studies did not analyze the effects of the specific music type and listening time in diagnostic and therapeutic gastrointestinal endoscopic procedures, respectively. This study will test whether the specific music type and listening time before gastrointestinal endoscopy could improve patients' experience of the procedure in a randomized controlled trial. The results may help to optimize the routine clinical practice at present.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotian Sun, M.D.; Phone Number: 86-010-66823480; Email: xiaotian-sun@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 18 years old patients
• Who agree to participate in the study
• Patients with the indications for gastrointestinal endoscopy

Exclusion Criteria:

• Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
• Severe uncontrolled coagulopathy
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients sit comfortably in a chair for 20 min listening classic music before the procedure.	Behavioral: Music listening; Patients sit comfortably in a chair for 20 min listening music before the procedure.
Experimental: Group B; Patients sit comfortably in a chair for 20 min listening popular music before the procedure.	Behavioral: Music listening; Patients sit comfortably in a chair for 20 min listening music before the procedure.
No Intervention: Control group; Patients sit comfortably in a chair for 20 min without music listening before the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	A 10-point scale was used to evaluate the patients' pain (0 least, 10 most). All the discomforts such as abdominal pain, distension and the like were all recorded.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' satisfaction and willingness to undergo gastrointestinal endoscopy again	A 10-point scale was used to evaluate the patients' satisfaction (0 worst, 10 best). It is anticipated that the use of music listening will significantly improve patients' satisfaction.	4 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Publications and helpful links

General Publications

• Lee D, Henderson A, Shum D. The effect of music on preprocedure anxiety in Hong Kong Chinese day patients. J Clin Nurs. 2004 Mar;13(3):297-303. doi: 10.1046/j.1365-2702.2003.00888.x.
• Hayes A, Buffum M, Lanier E, Rodahl E, Sasso C. A music intervention to reduce anxiety prior to gastrointestinal procedures. Gastroenterol Nurs. 2003 Jul-Aug;26(4):145-9. doi: 10.1097/00001610-200307000-00002.
• Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2009 Jan;54(1):19-24. doi: 10.1007/s10620-008-0312-0. Epub 2008 May 16.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 307-GIE-m

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No