Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Study Overview
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Brief Summary
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Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.

Detailed Description
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Behavioral: Comforting Conversation
* Behavioral: Standard Communication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comforting Conversation<br>Conversation according to the initital qualitative study. | Behavioral: Comforting Conversation<br>* Pain management, distraction, diversion, empathy. Dependent on qualitative study results.<br>Behavioral: Standard Communication<br>* Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.<br>|
| Active Comparator: Standard Communication<br>Standard information prior to and during endoscopy. | Behavioral: Standard Communication<br>* Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Questionnaire with 5 point Likert like scale | on average 20 minutes after completed colonoscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |