Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy

NCT01524042 | Unknown DMC

• 1 other identifier: 4-2011-0644
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Recently colonoscopy has gained importance as screening programs for colon polyp, cancer and inflammatory bowel disease in the United States and other countries. The number of colonoscopy performed has been increased year by year. To make an increased compliance with colonoscopy in both screening and clinical surveillance programs, consideration of anxiety, shame and satisfaction in examinee is regarded to be important. During colonoscopy patients wear conventional single pants where there is no hole for insertion of scope. Patients take off the conventional single pants below the buttocks and expose their buttocks and perianal area during colonoscopy. Exposing perianal and perineal area during colonoscopy can make patients feel shameful and anxious and diminish satisfaction of colonoscopy. Recently considering the factors affecting satisfaction has been regarded to be important because patient satisfaction could be one of the quality indicators for colonoscopy. To diminish shame and anxiety by exposing perianal and perineal area of patients wearing conventional single pants during colonoscopy, we developed novel double pants with a hole in inner pants. Novel double pants are composed of double fabrics from hip to thigh and single fabric under the thigh such as common pants. In the inner pants of double pants, there is a hole for insertion of scope. The hole is 25 cm wide and 15 cm long. The outer pants are same as conventional single pants. If the patients dropped outer pants below hips, only hip and perianal area are exposed through the hole (25cm\*15 cm) for insertion of scope without dropping inner pants. Therefore novel double pants minimized the exposed area of hips than conventional single pants because hips are exposed only the hole of inner pants. Smaller exposed area of hips by novel double pants can minimized the shame and anxiety by diminishing exposing perianal and perineal area during colonoscopy. Therefore advantage of novel double pants is decreasing shame and anxiety and increasing satisfaction by minimizing the exposed area of perianal and perineal area compared with conventional single pants. This study is a randomized controlled study. The investigators will survey the examinees older than 20 years who performed the colonoscopy at Severance Hospital from Feb. 2012 to Jul. 2012 to compare the effect on the satisfaction, shame, and anxiety during colonoscopy between the two groups.

Conditions

Colonoscopy

Keywords

Satisfaction; colonoscopy; double pants; single pants

Outcome Measures

Primary Outcomes (1)

• Satisfaction of patients during colonoscopy

  We measure the satisfaction during colonoscopy by questionnares

  10 minutes after colonoscopy

Secondary Outcomes (1)

• shame and anxiety of patient during colonoscopy

  20 minutes after colonoscopy

Study Arms (1)

group 2

EXPERIMENTAL

study group:double pants group

Procedure: Pants for colonoscopy

Interventions

Pants for colonoscopy PROCEDURE

We divide the patients into group 1 and group 2. The group 1 wear a conventional single pants and group 2 wear a novel double pants.

group 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 20 years who performed colonoscopy at Severance hospital

You may not qualify if:

• patients who underwent colonoscopy within 3 years
• patients with Psychotic problems
• patients with colostomy or ileostomy
• patients with bowel resection
• patients who needed emergent colonoscopy
• pregnant women
• lactating women
• illiterate person
• foreigners

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Soo Jung Park

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Soo Jung Park, Dr.

  Severance Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

KR (1)