Role of Music Listening in Gastrointestinal Endoscopy

NCT ID: NCT04096508

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Endoscopic Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Patients sit comfortably in a chair for 20 min listening classic music before the procedure.

Group Type EXPERIMENTAL

Music listening

Intervention Type BEHAVIORAL

Patients sit comfortably in a chair for 20 min listening music before the procedure.

Group B

Patients sit comfortably in a chair for 20 min listening popular music before the procedure.

Group Type EXPERIMENTAL

Music listening

Intervention Type BEHAVIORAL

Patients sit comfortably in a chair for 20 min listening music before the procedure.

Control group

Patients sit comfortably in a chair for 20 min without music listening before the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music listening

Patients sit comfortably in a chair for 20 min listening music before the procedure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiaotian Sun, M.D.

Role: CONTACT

86-010-66823480

References

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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.

Reference Type BACKGROUND
PMID: 15009332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12920428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18483858 (View on PubMed)

Other Identifiers

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307-GIE-m

Identifier Type: -

Identifier Source: org_study_id

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