CClinicalTrials.gg
Status unknownNCT02484105ComConEndoUpdated Sep 29, 2015

Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

A Phase 4 interventional study of Comforting Conversation and Standard Communication in Colonoscopy, sponsored by Jeppe Thue Jensen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-29.

Sponsored by Jeppe Thue Jensen · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Colonoscopy
03

In context

Lead sponsor

This is the only study on the registry with Jeppe Thue Jensen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18-85
  • Colonoscopy
  • Written informed content

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Comforting Conversation

    Conversation according to the initital qualitative study.

    Behavioral: Comforting Conversation · Behavioral: Standard Communication

  • Active comparator
    Standard Communication

    Standard information prior to and during endoscopy.

    Behavioral: Standard Communication

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.

06

What researchers measure

Primary outcomes

  1. Patient Satisfaction

    Questionnaire with 5 point Likert like scale

    Time frame: on average 20 minutes after completed colonoscopy.

Secondary outcomes

  1. Per-procedural Pain management

    Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale

    Time frame: From inclusion to completed procedure. On average 45 minutes from first to last measurement.

07

Study locations

1 of 1 sites recruiting
  • Endoscopy, Gastrounit, Herlev Hospital
    Herlev, Region H 2730, Denmark
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02484105
Lead sponsor
Jeppe Thue Jensen
Responsible party
Jeppe Thue Jensen (MD, Copenhagen University Hospital at Herlev) — Sponsor-investigator
First posted
Jun 29, 2015
Start date
Sep 2015
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Sep 29, 2015

Study contacts

Peter Vilmann, MD
Contact
Peter.Vilmann@regionh.dk

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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