NCT05154916

Brief Summary

With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients. The research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups. The researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure. The researcher will download the licensed program called 'a walk on the beach' to the virtual reality glasses and the patient will watch this program with glasses. The patient in the experimental group will have to fill in the Visual Analogue Scale, Anxiety Evaluation Form, Anxiety Symptoms Follow-up Form, and Patient Information Form before the procedure. 10-15 minutes after the procedure, the patient will be asked to fill the Visual Analogue Scale, Anxiety Evaluation Form, Anxiety Symptoms Follow-up Form and the Virtual Reality Glasses Application Satisfaction Form. No procedure will be applied to the patients in the control group and they will be asked to fill in the Patient Information Form, Visual Analogue Scale Form, Anxiety Evaluation Scale Form, and Anxiety Symptoms Follow-up Form before the procedure. After the procedure, he will be asked to fill in the other forms again, except the Patient Information Form. Patients over the age of 18, who have no communication problems, no psychiatric problems, who volunteered to participate in the study, and who had local application in bronchoscopy will be included in the study. Patients with psychiatric problems and communication problems will not be included in the study. Before the procedure, the patient will be informed that his/her identity information will be kept confidential and that he/she can withdraw from the research at any time, and all his/her rights will be informed.

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 Nov 2021

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 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

November 18, 2021

Last Update Submit

July 2, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale Evaluation

    Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain

    60 minutes

  • Virtual Reality Glasses Application Satisfaction Form

    In this form, there are questions prepared in line with the relevant literature (Dutucu, 2019) in order to determine the satisfaction with the video watched with virtual reality glasses.The higher the score, the higher the satisfaction

    60 minutes

  • Anxiety Assessment Scale

    Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.

    60 minutes

  • Physiological Symptoms of Anxiety Follow-up Form

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation value.These values will be checked again in 4 weeks.

    60 minutes

Study Arms (2)

Experimental:

EXPERIMENTAL

Bronchoscopy of Virtual Reality Based Relaxation Program Will Be Applied

Other: Virtual Reality Based Relaxation Program

No Intervention

NO INTERVENTION

Bronchoscopy of Virtual Reality Based Relaxation Program Will Not Be Applied

Interventions

Virtual Reality Based Relaxation Program

Experimental:

Eligibility Criteria

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

You may qualify if:

  • be18 years and over
  • Ability to communicate adequately
  • Absence of psychiatric problems
  • Those who are determined by the physician that they do not have a physical disability in exercising
  • Volunteering to participate in the research
  • Individuals who have the ability to use technological tools
  • Patients who underwent local application in bronchoscopy

You may not qualify if:

  • Those who have 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

Study Officials

  • Gülcan B Turan

    Firat University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 13, 2021

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations