Effect of Functional Relaxation on Patients Undergoing Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Relaxation
• Intervention / Treatment: Procedure: Functional relaxation; Procedure: No relaxation

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 403-720
    • Incheon St. Mary's hospital, Catholic university of Korea
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

• Previous colorectal resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional relaxation	Procedure: Functional relaxation; Functional relaxation during colonoscopy
Active Comparator: No relaxation	Procedure: No relaxation; No relaxation during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's abdominal pain during colonoscopy	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction	1 day

Other Outcome Measures

Outcome Measure	Time Frame
State Trait Anxiety Inventory (STAI)	1 day

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 12, 2013
• First Submitted That Met QC Criteria: October 12, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Relaxation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO