ColonoscopyNCT01524042
Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy
A study testing Pants for colonoscopy in people with Colonoscopy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Pants for colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients older than 20 years who performed colonoscopy at Severance hospital
Who cannot join
- 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
Show all 9Show fewer
- lactating women
- illiterate person
- foreigners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy: Prospective Randomized Study
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.
Read the 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
- Conditions
- Colonoscopy
- Being tested
- Pants for colonoscopy
- Keywords
- Satisfaction, colonoscopy, double pants, single pants
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pants for colonoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| group 2 | Experimental | study group:double pants group Receives: Procedure: Pants for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of patients during colonoscopy
We measure the satisfaction during colonoscopy by questionnares
Measured: 10 minutes after colonoscopy
Secondary outcomes (1)
shame and anxiety of patient during colonoscopy
We measure the satisfaction during colonoscopy by questionnares
Measured: 20 minutes after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soo Jung Park, Dr., Study director, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524042
- Sponsor's protocol ID
- 4-2011-0644
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01524042
- Acronym / sponsor ID
- 4-2011-0644
- Conditions
- Colonoscopy
- Keywords
- Satisfaction, colonoscopy, double pants, single pants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 2 | Experimental | Procedure: Pants for colonoscopystudy group:double pants group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 20 years who performed colonoscopy at Severance hospital
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pants for colonoscopyWe 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. | Procedure or surgery | group 2 |
Primary outcome
Satisfaction of patients during colonoscopy
Time frame: 10 minutes after colonoscopy
We measure the satisfaction during colonoscopy by questionnares
1 secondary outcome
shame and anxiety of patient during colonoscopy
Time frame: 20 minutes after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Jung Park, Dr. study director
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pants for colonoscopy in people with Colonoscopy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of patients during colonoscopy (time frame: 10 minutes after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.