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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01524042
First received: January 24, 2012
Last updated: January 29, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Colonoscopy
Procedure: Pants for colonoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy: Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Satisfaction of patients during colonoscopy [ Time Frame: 10 minutes after colonoscopy ] [ Designated as safety issue: No ]
    We measure the satisfaction during colonoscopy by questionnares


Secondary Outcome Measures:
  • shame and anxiety of patient during colonoscopy [ Time Frame: 20 minutes after colonoscopy ] [ Designated as safety issue: No ]
    We measure the satisfaction during colonoscopy by questionnares


Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 2
study group:double pants group
Procedure: Pants for colonoscopy
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.

Detailed Description:

Eighty examinees will wear conventional single pants and another eighty examinees will wear novel double pants randomly. Examinees who underwent colonoscopy within 3 years, with history of bowel resection surgery, cancer, colostomy or ileostomy, psychotic disease such as depression, anxiety disorder, obsessive disorder, treated with emergent colonoscopic procedure, and pregnant or lactating women, an illiterate person and foreigners will be excluded. Questionnaires before colonoscopy are educational background, martial status, indication of colonoscopy, examinee's preference of doctor's gender, and State-trait anxiety level of examinee. Questionnaires after colonoscopy are shame and trait anxiety level, and satisfaction of examinee during colonoscopy. We will also investigate colonoscopy specific quality Indicators such as the ASA status (American society of anesthesiologist's physical status), complications, procedure success. Finally we will compare the difference of satisfaction, shame, and anxiety during colonoscopy between examinees wearing novel double pants and conventional single pants

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524042

Locations
Korea, Republic of
Soo Jung Park
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Study Director: Soo Jung Park, Dr. Severance Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01524042     History of Changes
Other Study ID Numbers: 4-2011-0644
Study First Received: January 24, 2012
Last Updated: January 29, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Satisfaction
colonoscopy
double pants
single pants

ClinicalTrials.gov processed this record on November 25, 2014