AnxietyNCT05797142
Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy
A study testing Virtual reality glasses in people with Anxiety and Pain, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 8 Jul 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Ability to communicate adequately
- Absence of psychiatric problems
- Volunteering to participate in the research
Who cannot join
- Those who have communication problems
- Those with psychiatric problems
- Being unconscious
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Istanbul, Turkiye, 340340
About this study
Official title: The Effect of Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level and Patient Satisfaction in Patients to be Applied With Endoscopy
This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy.
Read the detailed description
Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.
- Being tested
- Virtual reality glasses
- Keywords
- virtual reality glasses, Pain, Anxiety, Endoscopy
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesOther
Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes).
| Study group | Role | What they receive |
|---|---|---|
| : Virtual reality glasses | Experimental | Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes). Receives: Other: Virtual reality glasses |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Measured: Baseline (Before endoscopy)
Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Measured: 5 minute after endoscopy
Secondary outcomes (5)
Anxiety Assessment Scale
Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Anxiety Assessment Scale, line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.
Measured: Baseline (Before endoscopy)
Anxiety Assessment Scale
Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Anxiety Assessment Scale, line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.
Measured: 5 minute after endoscopy
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 (SpO2) value.
Measured: Baseline (Before endoscopy)
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 (SpO2) value.
Measured: 1 minute after endoscopy
Virtual Reality Glasses Application Satisfaction Form
In this form, there are questions prepared in line with the relevant literature in order to determine the satisfaction with the video watched with virtual reality glasses.
Measured: 5 minute after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start5 May 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz Özer, PhD, Principal investigator, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797142
- Sponsor's protocol ID
- 2020-11
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
PubMed 35397973
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 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 Intensity, Anxiety Level and Patient Satisfaction in Patients to be Applied With Endoscopy
- ClinicalTrials.gov ID
- NCT05797142
- Acronym / sponsor ID
- 2020-11
- Keywords
- virtual reality glasses, Pain, Anxiety, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 4 Apr 2023 (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.
This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy.
Detailed description
Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| : Virtual reality glasses | Experimental | Other: Virtual reality glassesBeginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes). |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Ability to communicate adequately
- Absence of psychiatric problems
- Volunteering to participate in the research
Key exclusion criteria (3 listed)
- Those who have communication problems
- Those with psychiatric problems
- Being unconscious
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 glassesBeginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product "Secret Garden", during the procedure (30 minutes). | Other | : Virtual reality glasses |
Primary outcome
Visual Analog Scale
Time frame: Baseline (Before endoscopy)
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Visual Analog Scale
Time frame: 5 minute after endoscopy
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
5 secondary outcomes
Anxiety Assessment Scale
Time frame: Baseline (Before endoscopy)
Anxiety Assessment Scale
Time frame: 5 minute after endoscopy
Physiological Symptoms of Anxiety Follow-up Form
Time frame: Baseline (Before endoscopy)
Physiological Symptoms of Anxiety Follow-up Form
Time frame: 1 minute after endoscopy
Virtual Reality Glasses Application Satisfaction Form
Time frame: 5 minute after endoscopy
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 4 Apr 2023.
- Results publication: PubMed 35397973Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
- 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.
Zülfünaz Özer, PhD principal investigator
Istanbul Sabahattin Zaim 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 glasses in people with Anxiety and Pain, run by Istanbul Sabahattin Zaim 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 4 inclusion and 3 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 4 Apr 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 (time frame: Baseline (Before endoscopy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05797142, which also lists 1 linked publication.
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 4 Apr 2023.