NCT06407531

Brief Summary

This study was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows: H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs. H0: Virtual reality application before colonoscopy has no effect on patients' anxiety and vital signs. Before colonoscopy, patients in the study group will be asked to watch videos using virtual reality glasses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 18, 2026

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

May 3, 2024

Last Update Submit

May 15, 2026

Conditions

Keywords

virtual reality glassessurgical nursingcolonoscopy

Outcome Measures

Primary Outcomes (8)

  • Anxiety (Visual Analog Scale-Anxiety)

    Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    30 minutes before colonoscopy

  • Anxiety (Visual Analog Scale-Anxiety)

    Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    5-10 minutes before colonoscopy

  • Systolic blood pressure

    In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.

    30 minutes before colonoscopy

  • Systolic blood pressure

    In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.

    5-10 minutes before colonoscopy

  • Diastolic blood pressure

    In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.

    30 minutes before colonoscopy

  • Diastolic blood pressure

    In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.

    5-10 minutes before colonoscopy

  • Heart rate

    In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.

    5-10 minutes before colonoscopy

  • Heart rate

    In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.

    30 minutes before colonoscopy

Study Arms (2)

VR-G

EXPERIMENTAL

The patient will wear virtual glasses and watch a video 30 minutes before the procedure.

Other: VR-G

Control

NO INTERVENTION

No intervention will be performed on control group patients and the standard care protocol of the clinic will be applied.

Interventions

VR-GOTHER

Patients watched videos with virtual glasses before undergoing colonoscopy

VR-G

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the research,
  • Being literate,
  • Be 18 years or older.

You may not qualify if:

  • Performing colonoscopy at the same time as endoscopy,
  • Using any analgesic or anxiolytic,
  • Having a visual or hearing impairment,
  • Performing an emergency colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finike State Hospital

Antalya, Finike, 07740, Turkey (Türkiye)

Location

Related Publications (1)

  • Yenigun Akbulut SC, Alptekin HM, Unver S. Effectiveness of Virtual Reality Intervention on Anxiety and Vital Signs of Patients Before Colonoscopy: A Randomised Controlled Study. Nurs Open. 2026 Mar;13(3):e70465. doi: 10.1002/nop2.70465.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
While the principal investigator and another co-researcher collected data, the co-researcher collected and recorded the data without having any knowledge of the results of the study. Data analysis will be completed by an independent researcher.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 30 minutes before colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS. Afterwards, the patients were shown videos using virtual reality glasses. 5-10 minutes before the colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr.

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 9, 2024

Study Start

November 25, 2023

Primary Completion

May 30, 2024

Study Completion

July 1, 2024

Last Updated

May 18, 2026

Record last verified: 2024-07

Locations