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OpenTrials
Completed

NCT Number: NCT01963858

Effect of Functional Relaxation on Patients Undergoing Colonoscopy

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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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing screening or surveillance colonoscopy

Exclusion criteria

  • Previous colorectal resection

Treatment and study plan

Functional relaxation

Procedure

Functional relaxation during colonoscopy

No relaxation

Procedure

No relaxation during colonoscopy

Primary outcomes

  1. Patient's abdominal pain during colonoscopy

    Time frame: 1 day

Secondary outcomes

  1. Patient satisfaction

    Time frame: 1 day

Other outcomes

  1. State Trait Anxiety Inventory (STAI)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2013
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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