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Effect of Functional Relaxation on Patients Undergoing Colonoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01963858
Enrollment
120
Registered
2013-10-16
Start date
2013-10-31
Completion date
2016-05-31
Last updated
2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Relaxation

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.

Interventions

PROCEDUREFunctional relaxation

Functional relaxation during colonoscopy

PROCEDURENo relaxation

No relaxation during colonoscopy

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patient undergoing screening or surveillance colonoscopy

Exclusion criteria

* Previous colorectal resection

Design outcomes

Primary

MeasureTime frame
Patient's abdominal pain during colonoscopy1 day

Secondary

MeasureTime frame
Patient satisfaction1 day

Other

MeasureTime frame
State Trait Anxiety Inventory (STAI)1 day

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026