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NCT02484105 Clinical Trial

Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Colonoscopy Clinical Trial

— ComConEndo  

Official title:
Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02484105
Other study ID # H-15001924
Secondary ID
Status Recruiting
Phase Phase 4
First received June 23, 2015
Last updated September 28, 2015
Start date September 2015
Est. completion date January 2016

Study information
Verified date September 2015
Source Copenhagen University Hospital at Herlev
Contact Peter Vilmann, MD
Email Peter.Vilmann@regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 62
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Age 18-85

- Colonoscopy

- Written informed content

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Comforting Conversation
Pain management, distraction, diversion, empathy. Dependent on qualitative study results.
• Standard Communication
Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.

Locations
Country Name City State
Denmark Endoscopy, Gastrounit, Herlev Hospital Herlev Region H

Sponsors (1)
Lead Sponsor Collaborator
Jeppe Thue Jensen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Questionnaire with 5 point Likert like scale on average 20 minutes after completed colonoscopy. No
Secondary Per-procedural Pain management Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale From inclusion to completed procedure. On average 45 minutes from first to last measurement. No
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