Effect of Functional Relaxation on Patients Undergoing Colonoscopy

Colonoscopy Clinical Trial

Official title:

Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963858
• Other study ID #: Relaxation
• Status: Completed
• Phase: N/A
• First received: October 12, 2013
• Last updated: September 20, 2016
• Start date: October 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

• Previous colorectal resection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy
• Relaxation

Intervention

Procedure:
• Functional relaxation
Functional relaxation during colonoscopy
• No relaxation
No relaxation during colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's hospital, Catholic university of Korea	Incheon
Korea, Republic of	Uijeongbu St. Mary's Hospital, The Catholic University of Korea	Uijeongbu

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	State Trait Anxiety Inventory (STAI)		1 day	No
Primary	Patient's abdominal pain during colonoscopy		1 day	No
Secondary	Patient satisfaction		1 day	No