NCT04096508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 18, 2019

Last Update Submit

September 18, 2019

Conditions

Gastrointestinal Endoscopic Procedures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patients' satisfaction and willingness to undergo gastrointestinal endoscopy again

    4 months

Study Arms (3)

Group A

EXPERIMENTAL

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

Behavioral: Music listening

Group B

EXPERIMENTAL

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

Behavioral: Music listening

Control group

NO INTERVENTION

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

Interventions

Music listeningBEHAVIORAL

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

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (3)

  • 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.

    PMID: 15009332BACKGROUND

  • 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.

    PMID: 12920428BACKGROUND

  • 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.

    PMID: 18483858BACKGROUND

Central Study Contacts

Xiaotian Sun, M.D.

CONTACT

86-010-66823480xiaotian-sun@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

CN(1)