ColonoscopyPhase 4ComConEndoNCT02484105
Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction
A Phase 4 study testing Comforting Conversation and Standard Communication in people with Colonoscopy, run by Jeppe Thue Jensen at 1 site in Denmark.
Trial summary
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Comforting Conversation and Standard Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85
- Colonoscopy
- Written informed content
Who cannot join
- ASA Class 4 or higher
- BMI 40 or higher
- Analgesics taken prior to procedure
- Pregnancy or breast feeding
- Allergy to Fentanyl/Midazolam
- Daily consumption of opioids
- Unable to complete questionnaire
Trial locations and contacts
1 site in 1 country.
Peter Vilmann, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Endoscopy, Gastrounit, Herlev Hospital
Herlev, Region H, 2730
Jakob Hendel, MD, Jakob.Hendel@regionh.dk
Jeppe Thue Jensen, MD
About this study
Official title: Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.
Read the detailed description
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- Comforting Conversation, Standard Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comforting ConversationBehavioural
Pain management, distraction, diversion, empathy. Dependent on qualitative study results.
Standard CommunicationBehavioural
Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.
| Study group | Role | What they receive |
|---|---|---|
| Comforting Conversation | Experimental | Conversation according to the initital qualitative study. Receives: Behavioral: Comforting Conversation; Behavioral: Standard Communication |
| Standard Communication | Active comparator | Standard information prior to and during endoscopy. Receives: Behavioral: Standard Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Questionnaire with 5 point Likert like scale
Measured: on average 20 minutes after completed colonoscopy.
Secondary outcomes (1)
Per-procedural Pain management
Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale
Measured: From inclusion to completed procedure. On average 45 minutes from first to last measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeppe Thue Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeppe Thue Jensen, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484105
- Sponsor's protocol ID
- H-15001924
- Acronym
- ComConEndo
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT02484105
- Acronym / sponsor ID
- ComConEndo / H-15001924
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Jeppe Thue JensenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 Jun 2015 (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.
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.
Detailed description
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comforting Conversation | Experimental | Behavioral: Comforting Conversation, Behavioral: Standard CommunicationConversation according to the initital qualitative study. |
| Standard Communication | Active comparator | Behavioral: Standard CommunicationStandard information prior to and during endoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-85
- Colonoscopy
- Written informed content
Key exclusion criteria (7 listed)
- ASA Class 4 or higher
- BMI 40 or higher
- Analgesics taken prior to procedure
- Pregnancy or breast feeding
- Allergy to Fentanyl/Midazolam
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 |
|---|---|---|
| Comforting ConversationPain management, distraction, diversion, empathy. Dependent on qualitative study results. | Behavioural | Comforting Conversation |
| Standard CommunicationInformation on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure. | Behavioural | Comforting Conversation, Standard Communication |
Primary outcome
Patient Satisfaction
Time frame: on average 20 minutes after completed colonoscopy.
Questionnaire with 5 point Likert like scale
1 secondary outcome
Per-procedural Pain management
Time frame: From inclusion to completed procedure. On average 45 minutes from first to last measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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.
Peter Vilmann, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comforting Conversation and Standard Communication in people with Colonoscopy, run by Jeppe Thue Jensen at 1 site in Denmark.
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 3 inclusion and 7 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 29 Sep 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Peter Vilmann, MD (Peter.Vilmann@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: on average 20 minutes after completed 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 29 Sep 2015.