Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-01-31

Brief Summary

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

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Comforting Conversation

Conversation according to the initital qualitative study.

Group Type EXPERIMENTAL

Comforting Conversation

Intervention Type BEHAVIORAL

Pain management, distraction, diversion, empathy. Dependent on qualitative study results.

Standard Communication

Intervention Type BEHAVIORAL

Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.

Standard Communication

Standard information prior to and during endoscopy.

Group Type ACTIVE_COMPARATOR

Standard Communication

Intervention Type BEHAVIORAL

Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.

Interventions

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Comforting Conversation

Pain management, distraction, diversion, empathy. Dependent on qualitative study results.

Intervention Type BEHAVIORAL

Standard Communication

Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes