NCT06794112

Brief Summary

Our study presents an innovative educational approach combining visual and auditory elements, targeting the specific needs of the geriatric population. Generally, before colonoscopy, participants are given a written instruction describing the standard bowel preparation with the use of laxatives and enemas. In our study, in addition to this written instruction, the investigators aimed to support the bowel preparation procedure with visual training by using an animated video. The use of animated video has the potential to present complex medical instructions in a simple and understandable format. This approach is especially designed for elderly participants who have limited literacy skills or have difficulty in following written instructions. In addition, it was aimed to reduce the anxiety of the participants before the colonoscopy procedure and to increase patient compliance.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 20, 2025

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Bowel Preparation

    The primary outcome measure of this study is the quality of bowel preparation, which will be assessed using the Boston Bowel Preparation Scale (BBPS). This validated scale will be used to evaluate the cleanliness of each colonic segment during colonoscopy. The BBPS assigns a score of 0 to 3 for each of the three segments of the colon (right colon, transverse colon, and left colon), resulting in a total score ranging from 0 to 9. Adequate bowel preparation will be defined as a total BBPS score ≥ 6 with all segment scores ≥ 2. The assessment will be performed by endoscopists who are blinded to the patient's group allocation to minimize bias. This standardized evaluation will provide an objective measure of the effectiveness of our video-based educational intervention compared to standard written instructions in achieving optimal bowel preparation in the geriatric population.

    During colonoscopy procedure

Secondary Outcomes (1)

  • colonoscopy completion rate

    During colonoscopy procedure

Study Arms (2)

Animation video group

EXPERIMENTAL

Patients will receive standard written instructions and will additionally watch an animated training video

Other: Animated Educational VideoOther: Written Instructions

Written instructions only (Standard care) group

ACTIVE COMPARATOR

Patients will only receive standardised written instructions

Other: Written Instructions

Interventions

Both arms will receive standard care (written instructions), with the experimental arm receiving an additional animated video intervention.

Animation video group

Standard written instructions for bowel preparation before colonoscopy

Animation video groupWritten instructions only (Standard care) group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Indication for colonoscopy
  • Volunteering to participate in the study
  • Preparing for colonoscopy for the first time
  • No history of previous operations on the small intestine and colon
  • No diagnosed bowel disease
  • Language proficiency to watch the animation
  • Full understanding of visual and auditory messages

You may not qualify if:

  • Previous colonoscopy experience
  • History of previous small bowel and colon surgery
  • Diagnosis of inflammatory bowel disease
  • Presence of toxic colon and/or megacolon
  • The presence of a mass in the intestine that does not allow colonoscopy to pass
  • Unwillingness to participate in the study
  • Lack of language proficiency
  • Lack of ability to understand visual and auditory messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Medicine

Mersin, 33110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Ye Z, Chen J, Xuan Z, Gao M, Yang H. Educational video improves bowel preparation in patients undergoing colonoscopy: a systematic review and meta-analysis. Ann Palliat Med. 2020 May;9(3):671-680. doi: 10.21037/apm.2020.03.33. Epub 2020 Apr 13.

    PMID: 32312062BACKGROUND
  • Ho LH, Montealegre JR, Al-Arabi S, Jibaja-Weiss ML, Suarez MG. Impact of Colonoscopy Preparation Video on Boston Bowel Preparation Scale Score. Gastroenterol Nurs. 2019 May/Jun;42(3):251-258. doi: 10.1097/SGA.0000000000000391.

    PMID: 31145249BACKGROUND
  • Hayat U, Lee PJ, Lopez R, Vargo JJ, Rizk MK. Online Educational Video Improves Bowel Preparation and Reduces the Need for Repeat Colonoscopy Within Three Years. Am J Med. 2016 Nov;129(11):1219.e1-1219.e9. doi: 10.1016/j.amjmed.2016.06.011. Epub 2016 Jul 6.

    PMID: 27393880BACKGROUND

Study Officials

  • Simge Tuna

    Mersin University

    STUDY CHAIR

Central Study Contacts

Simge Tuna

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

February 15, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations