NCT01963858

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

October 12, 2013

Last Update Submit

September 20, 2016

Conditions

ColonoscopyRelaxation

Outcome Measures

Primary Outcomes (1)

  • Patient's abdominal pain during colonoscopy

    1 day

Secondary Outcomes (1)

  • Patient satisfaction

    1 day

Other Outcomes (1)

  • State Trait Anxiety Inventory (STAI)

    1 day

Study Arms (2)

Functional relaxation

EXPERIMENTAL

Functional relaxation

Procedure: Functional relaxation

No relaxation

ACTIVE COMPARATOR

No relaxation

Procedure: No relaxation

Interventions

Functional relaxationPROCEDURE

Functional relaxation during colonoscopy

Functional relaxation
No relaxationPROCEDURE

No relaxation during colonoscopy

No relaxation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing screening or surveillance colonoscopy

You may not qualify if:

  • Previous colorectal resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Incheon, 403-720, South Korea

Location

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

Uijeongbu-si, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 12, 2013

First Posted

October 16, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)