Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction (ComConEndo)

Jeppe Thue Jensen

Status and phase: Unknown; Phase 4

Conditions: Colonoscopy

Treatments: Behavioral: Standard Communication; Behavioral: Comforting Conversation

Study type: Interventional

Funder types: Other

Identifiers

NCT02484105

H-15001924

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Comforting Conversation

Experimental group

Description:

Conversation according to the initital qualitative study.

Treatment:

Behavioral: Comforting Conversation

Behavioral: Standard Communication

Standard Communication

Active Comparator group

Description:

Standard information prior to and during endoscopy.

Treatment:

Behavioral: Standard Communication