Role of Music Listening in Gastrointestinal Endoscopy

Gastrointestinal Endoscopic Procedures Clinical Trial

Official title:

Application of Music Listening in Gastrointestinal Endoscopic Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04096508
• Other study ID #: 307-GIE-m
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2019
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Xiaotian Sun, M.D.
• Phone: 86-010-66823480
• Email: xiaotian-sun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Endoscopic Procedures

Intervention

Behavioral:
• Music listening
Patients sit comfortably in a chair for 20 min listening music before the procedure.

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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