BronchoscopyNCT05154916
The Effect of Virtual Reality Based Relaxation Program on Patients to be Performed Bronchoscopy
A study testing Virtual Reality Based Relaxation Program in people with Bronchoscopy and Virtual Reality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchoscopy, Virtual Reality, Glasses
- What is being tested?
- Virtual Reality Based Relaxation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who have communication problems
- Those with psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality-Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy
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.
Read the detailed description
This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. The virtual reality environment will be organized on the basis of relaxation exercise. In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound. Afterwards, the relaxation exercise created will be applied to the patients before and during the bronchoscopy application. The aim of this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy.
- Conditions
- Bronchoscopy, Virtual Reality, Glasses, Relaxation Program
- Being tested
- Virtual Reality Based Relaxation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Based Relaxation ProgramOther
Virtual Reality Based Relaxation Program
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Experimental | Bronchoscopy of Virtual Reality Based Relaxation Program Will Be Applied Receives: Other: Virtual Reality Based Relaxation Program |
| No Intervention | No intervention | Bronchoscopy of Virtual Reality Based Relaxation Program Will Not Be Applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Nov 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gülcan bahcecioğlu, Ataturk University
- Investigators
- Gülcan B Turan, Study chair, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154916
- Sponsor's protocol ID
- E-97132852-050.01.04-87889
- Status last verified
- Jul 2023
- First submitted
- 18 Nov 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality-Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy
- ClinicalTrials.gov ID
- NCT05154916
- Acronym / sponsor ID
- E-97132852-050.01.04-87889
- Conditions
- Bronchoscopy, Virtual Reality, Glasses, Relaxation Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. The virtual reality environment will be organized on the basis of relaxation exercise. In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound. Afterwards, the relaxation exercise created will be applied to the patients before and during the bronchoscopy application. The aim of this study; It is aimed to examine the Effect of Virtual Reality Based Relaxation Program on Pain Severity, Anxiety Level and Patient Satisfaction in Patients to be Performed Bronchoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Other: Virtual Reality Based Relaxation ProgramBronchoscopy of Virtual Reality Based Relaxation Program Will Be Applied |
| No Intervention | No intervention | –Bronchoscopy of Virtual Reality Based Relaxation Program Will Not Be Applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Those who have communication problems
- Those with psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Based Relaxation ProgramVirtual Reality Based Relaxation Program | Other | Experimental: |
Primary outcome
Visual Analog Scale Evaluation
Time frame: 60 minutes
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
Virtual Reality Glasses Application Satisfaction Form
Time frame: 60 minutes
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
Anxiety Assessment Scale
Time frame: 60 minutes
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.
Physiological Symptoms of Anxiety Follow-up Form
Time frame: 60 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülcan B Turan study chair
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Based Relaxation Program in people with Bronchoscopy and Virtual Reality, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Evaluation (time frame: 60 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.