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
• 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

• Colonoscopy

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