PainVirtualNCT05585853
The Effect of Virtual Reality Glasses on Pain Level and Hemo-Dynamic Variables After Open Heart Surgery
A study testing virtual reality in people with Pain and Hemodynamic Instability, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
In this study, between 1 January 2025 - 1 June 2025, who met the inclusion and exclusion criteria, a total of 82 patients who are on the 2nd or 3rd day after the surgery and who are hospitalized in the cardiovascular surgery intensive care clinic will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Hemodynamic Instability
- What is being tested?
- virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 26 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the research (signing the Informed Consent Form),
- Conscious and cooperative,
- Stable hemodynamic status,
- Speaks and understands Turkish,
- Over 18 years old,
- On the 2nd and 3rd day after open heart surgery,
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- Having chest tube,
- No sensitivity or trauma in the area (for the study group) where the virtual reality glasses will be applied,
- No active COVID-19 infection,
- Patients without any psychiatric diagnosis
Who cannot join
- Agreeing to participate in the research (signing the Informed Consent Form),
- Not conscious,
- Not cooperative
- Unstable hemodynamic status,
- Speaks and understands Turkish,
- who are under the age of 18,
Show all 11Show fewer
- On the 0th or 1st day after surgery,
- No chest tube,
- Has sensitivity or trauma in the area (for the study group) where the virtual reality
- Active COVID-19 infection,
- Patients with a psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University,
Mersin, Turkey, 33343
About this study
Official title: The Effect of Virtual Reality Glasses Applied on Chest Tube Removal After Open Heart Surgery on Pain Level and Hemodynamic Variables
In this study, between 1 January 2025 - 1 June 2025, who met the inclusion and exclusion criteria, a total of 82 patients who are on the 2nd or 3rd day after the surgery and who are hospitalized in the cardiovascular surgery intensive care clinic will be recruited.
Read the detailed description
The patient will be put on virtual reality glasses five minutes before the chest tube is removed. Afterwards, it will continue to be watched while the tube is taken and virtual reality glasses will be watched for another five minutes. Pain level and hemodynamic variables will be checked before, during, and 15 and 30 minutes after virtual reality glasses are watched. The participants in the control group will receive routine treatment and care, and their data will be collected at the same time as those in the study group. Hemodynamic variables will be monitored and recorded on the monitor.
Virtual reality glasses application is a method without any side effects. During the research, any adverse condition (vision problem, nausea, dizziness, etc.) related to the use of virtual glasses will be observed by the researcher. Since virtual reality glasses will be used in another patient after being used on one patient, disinfection will be made in line with the company's recommendations, taking into account the pandemic conditions. Throughout the application, feedback will be received from the patients by the researchers.
- Conditions
- Pain, Hemodynamic Instability
- Being tested
- virtual reality
- Keywords
- pain, Virtual reality glasses, open heart surgery, hemodynamic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Virtual reality glasses application is a method without any side effects. Patients will be treated for an average of 10 minutes. Data will be collected before, during, immediately after the application, at the 15th and 30th minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality application group | Experimental | Virtual reality glasses (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) compatible with the mobile phone (Lenovo P2a42) with the Android operating system will be worn and the patient will be watched (underwater world, open-air museum tours, beach trips and nature scenes) by patients for an average of 10 minutes during chest tube removal. Receives: Other: virtual reality |
| Standard of care | No intervention | Only standard care will be given and no application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the Visual Analogue Scale
Visual Analogue Scala has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a safe and easily applicable scale tool generally accepted in the world literature, consists of a 10 cm long line and there are subjective descriptive expressions at both ends of the scale (0 cm = none at all and 10 cm = highest degree.)
Measured: Change from before implementation up to 30 minutes
Secondary outcomes (5)
Systolic blood pressure
Systolic blood pressure (SBP), mmHg
Measured: Change from before implementation up to 30 minutes
Diastolic blood pressure
Diastolic blood pressure (DBP), mmHg
Measured: Change from before implementation up to 30 minutes
Heart rate
Beats per minute
Measured: Change from before implementation up to 30 minutes
Respiratory rate
Lung breathing
Measured: Change from before implementation up to 30 minutes
Peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: Change from before implementation up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Jan 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
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 PainStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Gülay ALTUN UĞRAŞ, PhD, Principal investigator, Mersin UniversitySevban ARSLAN, PhD, Principal investigator, Cukurova UniversityMuaz GÜLŞEN, master, Principal investigator, Cukurova UniversityFirdevs Ebru ÖZDEMİR, master, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585853
- Sponsor's protocol ID
- MersinUnii
- Acronym
- Virtual
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yanik TC, Gulsen M, Ugras GA, Arslan S, Ozdemi̇r FE. The effect of virtual reality glasses used during chest tube removal following open-heart surgery on pain and hemodynamic parameters: a randomized controlled trial. BMC Cardiovasc Disord. 2026 Oct 8;26(1):993. doi: 10.1186/s12872-026-06778-6.
PubMed 42958055
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Applied on Chest Tube Removal After Open Heart Surgery on Pain Level and Hemodynamic Variables
- ClinicalTrials.gov ID
- NCT05585853
- Acronym / sponsor ID
- Virtual / MersinUnii
- Conditions
- Pain, Hemodynamic Instability
- Keywords
- pain, Virtual reality glasses, open heart surgery, hemodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 19 Oct 2022 (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.
In this study, between 1 January 2025 - 1 June 2025, who met the inclusion and exclusion criteria, a total of 82 patients who are on the 2nd or 3rd day after the surgery and who are hospitalized in the cardiovascular surgery intensive care clinic will be recruited.
Detailed description
The patient will be put on virtual reality glasses five minutes before the chest tube is removed. Afterwards, it will continue to be watched while the tube is taken and virtual reality glasses will be watched for another five minutes. Pain level and hemodynamic variables will be checked before, during, and 15 and 30 minutes after virtual reality glasses are watched. The participants in the control group will receive routine treatment and care, and their data will be collected at the same time as those in the study group. Hemodynamic variables will be monitored and recorded on the monitor.
Virtual reality glasses application is a method without any side effects. During the research, any adverse condition (vision problem, nausea, dizziness, etc.) related to the use of virtual glasses will be observed by the researcher. Since virtual reality glasses will be used in another patient after being used on one patient, disinfection will be made in line with the company's recommendations, taking into account the pandemic conditions. Throughout the application, feedback will be received from the patients by the researchers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality application group | Experimental | Other: virtual realityVirtual reality glasses (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) compatible with the mobile phone (Lenovo P2a42) with the Android operating system will be worn and the patient will be watched (underwater world, open-air museum tours, beach trips and nature scenes) by patients for an average of 10 minutes during chest tube removal. |
| Standard of care | No intervention | –Only standard care will be given and no application will be made. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agreeing to participate in the research (signing the Informed Consent Form),
- Conscious and cooperative,
- Stable hemodynamic status,
- Speaks and understands Turkish,
- Over 18 years old,
Key exclusion criteria (11 listed)
- Agreeing to participate in the research (signing the Informed Consent Form),
- Not conscious,
- Not cooperative
- Unstable hemodynamic status,
- Speaks and understands Turkish,
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 realityVirtual reality glasses application is a method without any side effects. Patients will be treated for an average of 10 minutes. Data will be collected before, during, immediately after the application, at the 15th and 30th minutes. | Other | Virtual Reality application group |
Primary outcome
Pain evaluated using the Visual Analogue Scale
Time frame: Change from before implementation up to 30 minutes
Visual Analogue Scala has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a safe and easily applicable scale tool generally accepted in the world literature, consists of a 10 cm long line and there are subjective descriptive expressions at both ends of the scale (0 cm = none at all and 10 cm = highest degree.)
5 secondary outcomes
Systolic blood pressure
Time frame: Change from before implementation up to 30 minutes
Diastolic blood pressure
Time frame: Change from before implementation up to 30 minutes
Heart rate
Time frame: Change from before implementation up to 30 minutes
Respiratory rate
Time frame: Change from before implementation up to 30 minutes
Peripheral oxygen saturation
Time frame: Change from before implementation up to 30 minutes
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 25 Sep 2026.
- Derived from this study: PubMed 42958055Yanik TC, Gulsen M, Ugras GA, Arslan S, Ozdemi̇r FE. The effect of virtual reality glasses used during chest tube removal following open-heart surgery on pain and hemodynamic parameters: a randomized controlled trial. BMC Cardiovasc Disord. 2026 Oct 8;26(1):993. doi: 10.1186/s12872-026-06778-6.
- 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.
Gülay ALTUN UĞRAŞ, PhD principal investigator
Mersin University
Sevban ARSLAN, PhD principal investigator
Cukurova University
Muaz GÜLŞEN, master principal investigator
Cukurova 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 in people with Pain and Hemodynamic Instability, run by Mersin 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 10 inclusion and 11 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 25 Sep 2026. 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?
Pain evaluated using the Visual Analogue Scale (time frame: Change from before implementation up to 30 minutes). 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 NCT05585853, 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 25 Sep 2026.