Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02484105

Acronym

ComConEndo

Enrollment

Registered

2015-06-29

Start date

2015-09-30

Completion date

2016-01-31

Last updated

2015-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

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.

Interventions

BEHAVIORALComforting Conversation

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

BEHAVIORALStandard Communication

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Denmark

Contacts

Primary ContactPeter Vilmann, MD

Peter.Vilmann@regionh.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026