NCT07664800

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 7, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

colonoscopynursingpainanxietycomfort

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Level

    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 Outcomes (2)

  • Pain Level

    Before and after colonoscopy procedure (same day)

  • Comfort Level

    Before and after colonoscopy procedure (same day)

Study Arms (2)

Control Group

NO INTERVENTION

Patients receiving routine care without additional counseling

Intervention

EXPERIMENTAL

Patients receiving nurse-delivered online counseling before colonoscopy

Other: Online Nursing Counseling

Interventions

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.

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University Faculty of Health Sciences, Nursing Department

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 25223578BACKGROUND
  • 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.

    PMID: 32377915BACKGROUND
  • 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.

    PMID: 24454341BACKGROUND
  • 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.

    PMID: 32557475BACKGROUND
  • 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.

    PMID: 28848777BACKGROUND
  • 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.

    PMID: 27741260BACKGROUND
  • 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.

    PMID: 30385831BACKGROUND
  • Yılmaz E, Aslan A, Ergın E. Kolonoskopi Yapılacak Hastalarda Bağırsak Temizliğine Öz Etkililik Düzeylerinin Etkisi. CBU-SBED. 2018;5(4):192-198.

    BACKGROUND

MeSH Terms

Conditions

LiteracyOrientation, SpatialCell Phone UsePainAnxiety Disorders

Condition Hierarchy (Ancestors)

CommunicationBehaviorSpatial BehaviorSocial BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

June 24, 2026

Study Start

March 1, 2023

Primary Completion

April 1, 2023

Study Completion

June 30, 2023

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available due to ethical and confidentiality considerations.

Locations