Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT02484105
  4. Details
NCT02484105 Clinical Trial

Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Colonoscopy Clinical Trial

— ComConEndo  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02484105
Other study ID # H-15001924
Secondary ID
Status Recruiting
Phase Phase 4
First received June 23, 2015
Last updated September 28, 2015
Start date September 2015
Est. completion date January 2016

Study information
Verified date September 2015
Source Copenhagen University Hospital at Herlev
Contact Peter Vilmann, MD
Email Peter.Vilmann@regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 62
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Comforting Conversation
Pain management, distraction, diversion, empathy. Dependent on qualitative study results.
• Standard Communication
Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.

Locations
Country Name City State
Denmark Endoscopy, Gastrounit, Herlev Hospital Herlev Region H

Sponsors (1)
Lead Sponsor Collaborator
Jeppe Thue Jensen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Questionnaire with 5 point Likert like scale on average 20 minutes after completed colonoscopy. No
Secondary Per-procedural Pain management Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale From inclusion to completed procedure. On average 45 minutes from first to last measurement. No
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A
Completed NCT05397158 - Optimization of Intestinal Preparation in Older Patients N/A