NCT06003543

Brief Summary

Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or treating gastrointestinal system diseases by entering through the anus with a flexible, thin tube with a camera at the end, called a colonoscope. All parts of the large intestine with colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic interventions applied in gastroenterology cause pain, fear and anxiety in patients.

Trial Health

87
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
Completed

Started Oct 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

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

August 16, 2023

Last Update Submit

March 7, 2025

Conditions

Keywords

FearColonoscopy,PainAnxiety

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale -Pain

    Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm

    1 hours later

  • Visual Analog Scale - Fear

    Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each marked point is measured in cm

    1 hours later

  • Visual Analog Scale -Anxiety

    Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm

    1 hours later

  • State-Trait Anxiety Inventory

    Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977). assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale.

    1 hours later

Study Arms (2)

Virtual Reality

EXPERIMENTAL

virtual glasses will be applied

Behavioral: Virtual Reality

Control

NO INTERVENTION

no application will be made

Interventions

Virtual RealityBEHAVIORAL

Virtual Reality

Virtual Reality

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak and understand Turkish
  • Having cognitive competence to answer data collection tools
  • Absence of communication problems (hearing, language, understanding, etc.)
  • Not having a psychiatric diagnosis
  • Absence of a history of convulsions
  • Patients who underwent local application in colonoscopy

You may not qualify if:

  • Those with communication problems
  • Those with psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Gülcan B.TURAN

    Firat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

October 15, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations