NCT02484105

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

June 23, 2015

Last Update Submit

September 28, 2015

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Questionnaire with 5 point Likert like scale

    on average 20 minutes after completed colonoscopy.

Secondary Outcomes (1)

  • Per-procedural Pain management

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

Study Arms (2)

Comforting Conversation

EXPERIMENTAL

Conversation according to the initital qualitative study.

Behavioral: Comforting ConversationBehavioral: Standard Communication

Standard Communication

ACTIVE COMPARATOR

Standard information prior to and during endoscopy.

Behavioral: Standard Communication

Interventions

Comforting ConversationBEHAVIORAL

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

Comforting Conversation
Standard CommunicationBEHAVIORAL

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

Comforting ConversationStandard Communication

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85
  • Colonoscopy
  • Written informed content

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy, Gastrounit, Herlev Hospital

Herlev, Region H, 2730, Denmark

RECRUITING

Central Study Contacts

Peter Vilmann, MD

CONTACT

Peter.Vilmann@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 29, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

DK(1)