Role of Music Listening in Gastrointestinal Endoscopy

Not Applicable

• Conditions: Gastrointestinal Endoscopic Procedures
• Interventions: Behavioral: Music listening

• Registration Number: NCT04096508
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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.

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 Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-20
• Last Update Posted: 2019-09-20
• Study Start: 2019-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Music listening	Patients sit comfortably in a chair for 20 min listening popular music before the procedure.
Group A	Music listening	Patients sit comfortably in a chair for 20 min listening classic music before the procedure.

Primary Outcome Measures

Name	Time	Method
Pain score	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction and willingness to undergo gastrointestinal endoscopy again	4 months	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.

Trial Locations

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China