- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664800
Online Nursing Counseling and Colonoscopy Outcomes
June 23, 2026 updated by: Sinem Bebek, Sanko University
The Effect of Nurse-Delivered Online Counseling on Invasive Pain, Anxiety, and Comfort Levels in Patients Undergoing Colonoscopy
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March and June 2023 to evaluate the effect of nurse-delivered counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy.
Sixty patients were assigned to intervention (n=30) and control (n=30) groups.
The intervention group received counseling beginning 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages, while the control group received routine care.
Anxiety was assessed using the State Anxiety Scale, and pain and comfort were evaluated using the Visual Analog Scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled experimental study was conducted in the endoscopy unit of a private hospital between March 2023 and June 2023.
The study was designed to evaluate the effect of nurse-delivered online counseling on pain, anxiety, and comfort levels in patients undergoing colonoscopy.
Sixty eligible patients were assigned to either an intervention group (n=30) or a control group (n=30) using the minimization method.
Patients in the intervention group received online counseling based on standard colonoscopy preparation materials beginning approximately 24 hours before the procedure, including face-to-face education, telephone support, and reminder messages.
Patients in the control group received routine care only.
Anxiety was assessed using the State-Trait Anxiety Inventory, while pain and comfort were evaluated using the Visual Analog Scale.
Outcome measures were collected before and after the colonoscopy procedure.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey (Türkiye), 27090
- Sanko University Faculty of Health Sciences, Nursing Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years
- Literate
- No communication or hearing impairment
- Conscious and able to respond to questions
- Scheduled for colonoscopy
- Not using regular analgesic or antidepressant medications
- Voluntary participation
- No prior colonoscopy
- No diagnosis of colorectal cancer
- No diagnosis of inflammatory bowel disease
- No diagnosis of Crohn's disease
- Access to the internet and a smartphone, tablet, or computer
- Able to use WhatsApp
Exclusion Criteria:
- Age <18 years
- Illiterate
- Presence of communication or hearing impairment
- Cognitive impairment or inability to provide informed consent
- Not scheduled for colonoscopy
- Regular use of analgesic or antidepressant medications
- Refusal to participate
- History of prior colonoscopy
- Diagnosis of colorectal cancer
- Diagnosis of inflammatory bowel disease
- Diagnosis of Crohn's disease
- No access to the internet or lack of a smartphone, tablet, or computer
- Inability to use WhatsApp
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Patients receiving routine care without additional counseling
|
|
|
Experimental: Intervention
Patients receiving nurse-delivered online counseling before colonoscopy
|
Participants received nurse-delivered online counseling based on standard colonoscopy preparation materials.
The intervention started approximately 24 hours before the procedure and included an initial face-to-face education session, followed by 24-hour telephone support and reminder messages.
Participants were also able to contact the nurse for questions during this period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Level
Time Frame: Before and after colonoscopy procedure (same day)
|
Measured using the State-Trait Anxiety Inventory (State Anxiety Scale; score range 20-80, higher scores indicate higher anxiety).
|
Before and after colonoscopy procedure (same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Level
Time Frame: Before and after colonoscopy procedure (same day)
|
Measured using the Visual Analog Scale (VAS), a self-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Before and after colonoscopy procedure (same day)
|
|
Comfort Level
Time Frame: Before and after colonoscopy procedure (same day)
|
Measured using the Visual Analog Scale (VAS), a self-reported scale ranging from 0 to 10, where 0 indicates no comfort and 10 indicates maximum comfort.
Higher scores indicate greater comfort.
|
Before and after colonoscopy procedure (same day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
- Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.
- Shieh TY, Chen MJ, Chang CW, Hung CY, Hu KC, Kuo YC, Shih SC, Wang HY. Effect of physician-delivered patient education on the quality of bowel preparation for screening colonoscopy. Gastroenterol Res Pract. 2013;2013:570180. doi: 10.1155/2013/570180. Epub 2013 Dec 17.
- Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Richard Boland C, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2014 Oct;109(10):1528-45. doi: 10.1038/ajg.2014.272. Epub 2014 Sep 16. No abstract available.
- Alvarez-Gonzalez MA, Pantaleon Sanchez MA, Bernad Cabredo B, Garcia-Rodriguez A, Frago Larramona S, Nogales O, Diez Redondo P, Puig Del Castillo I, Romero Mascarell C, Caballero N, Romero Sanchez-Miguel I, Perez Berbegal R, Hernandez Negrin D, Bujedo Sadornill G, Perez Oltra A, Casals Urquiza G, Amoros Martinez J, Seoane Urgorri A, Ibanez Zafon IA, Gimeno-Garcia AZ. Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial. Endoscopy. 2020 Nov;52(11):1026-1035. doi: 10.1055/a-1178-9844. Epub 2020 Jun 17.
- Elvas L, Brito D, Areia M, Carvalho R, Alves S, Saraiva S, Cadime AT. Impact of Personalised Patient Education on Bowel Preparation for Colonoscopy: Prospective Randomised Controlled Trial. GE Port J Gastroenterol. 2017 Jan;24(1):22-30. doi: 10.1159/000450594. Epub 2016 Nov 1.
- Kurlander JE, Sondhi AR, Waljee AK, Menees SB, Connell CM, Schoenfeld PS, Saini SD. How Efficacious Are Patient Education Interventions to Improve Bowel Preparation for Colonoscopy? A Systematic Review. PLoS One. 2016 Oct 14;11(10):e0164442. doi: 10.1371/journal.pone.0164442. eCollection 2016.
- Yılmaz E, Aslan A, Ergın E. Kolonoskopi Yapılacak Hastalarda Bağırsak Temizliğine Öz Etkililik Düzeylerinin Etkisi. CBU-SBED. 2018;5(4):192-198.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
April 1, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
May 7, 2026
First Submitted That Met QC Criteria
June 23, 2026
First Posted (Actual)
June 24, 2026
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SANKOU-HEMS-SBS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be publicly available due to ethical and confidentiality considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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