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Effect of Functional Relaxation on Patients Undergoing Colonoscopy

NCT ID: NCT01963858

Last Updated: 2016-09-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-05-31

Brief Summary

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Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is the most common reason for low acceptance of colonoscopy. Several methods have been used to minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to participate in administration of medication. Although a potential benefit from some of these methods has been suggested, no clear recommendations have been made so far. We hypothesized functional relaxation reduces discomfort during colonoscopy.

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Detailed Description

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Conditions

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Colonoscopy Relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Functional relaxation

Functional relaxation

Group Type EXPERIMENTAL

Functional relaxation

Intervention Type PROCEDURE

Functional relaxation during colonoscopy

No relaxation

No relaxation

Group Type ACTIVE_COMPARATOR

No relaxation

Intervention Type PROCEDURE

No relaxation during colonoscopy

Interventions

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Functional relaxation

Functional relaxation during colonoscopy

Intervention Type PROCEDURE

No relaxation

No relaxation during colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria

* Previous colorectal resection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Seon Ji

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Incheon St. Mary's hospital, Catholic university of Korea

Incheon, , South Korea

Site Status

Uijeongbu St. Mary's Hospital, The Catholic University of Korea

Uijeongbu-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Relaxation

Identifier Type: -

Identifier Source: org_study_id

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