ColonoscopyNCT01963858
Effect of Functional Relaxation on Patients Undergoing Colonoscopy
A study testing Functional relaxation and No relaxation in people with Colonoscopy and Relaxation, run by The Catholic University of Korea at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Relaxation
- What is being tested?
- Functional relaxation and No relaxation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2013to May 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing screening or surveillance colonoscopy
Who cannot join
- Previous colorectal resection
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Incheon St. Mary's hospital, Catholic university of Korea
Incheon, 403-720
Uijeongbu St. Mary's Hospital, The Catholic University of Korea
Uijeongbu-si
About this study
Official title: Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial
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.
- Conditions
- Colonoscopy, Relaxation
- Being tested
- Functional relaxation, No relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional relaxationProcedure or surgery
Functional relaxation during colonoscopy
No relaxationProcedure or surgery
No relaxation during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Functional relaxation | Experimental | Functional relaxation Receives: Procedure: Functional relaxation |
| No relaxation | Active comparator | No relaxation Receives: Procedure: No relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's abdominal pain during colonoscopy
Measured: 1 day
Secondary outcomes (1)
Patient satisfaction
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionMay 2016
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Seon Ji, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963858
- Sponsor's protocol ID
- Relaxation
- Status last verified
- Sep 2016
- First submitted
- 12 Oct 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01963858
- Acronym / sponsor ID
- Relaxation
- Conditions
- Colonoscopy, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Oct 2013 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional relaxation | Experimental | Procedure: Functional relaxationFunctional relaxation |
| No relaxation | Active comparator | Procedure: No relaxationNo relaxation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing screening or surveillance colonoscopy
Key exclusion criteria (1 listed)
- Previous colorectal resection
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 |
|---|---|---|
| Functional relaxationFunctional relaxation during colonoscopy | Procedure or surgery | Functional relaxation |
| No relaxationNo relaxation during colonoscopy | Procedure or surgery | No relaxation |
Primary outcome
Patient's abdominal pain during colonoscopy
Time frame: 1 day
1 secondary outcome
Patient satisfaction
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional relaxation and No relaxation in people with Colonoscopy and Relaxation, run by The Catholic University of Korea at 2 sites 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 1 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: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient's abdominal pain during colonoscopy (time frame: 1 day). 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 21 Sep 2016.