Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Phase 4

• Conditions: Colonoscopy
• Interventions: Behavioral: Comforting Conversation; Behavioral: Standard Communication

• Registration Number: NCT02484105
• Lead Sponsor: Jeppe Thue Jensen

Brief Summary

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 Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Status Verified: 2015-09
• Study Start: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comforting Conversation	Comforting Conversation	Conversation according to the initital qualitative study.
Comforting Conversation	Standard Communication	Conversation according to the initital qualitative study.
Standard Communication	Standard Communication	Standard information prior to and during endoscopy.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	on average 20 minutes after completed colonoscopy.	Questionnaire with 5 point Likert like scale

Secondary Outcome Measures

Name	Time	Method
Per-procedural Pain management	From inclusion to completed procedure. On average 45 minutes from first to last measurement.	Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale

Trial Locations

Locations (1)

Endoscopy, Gastrounit, Herlev Hospital; 🇩🇰 Herlev, Region H, Denmark