Pain ManagementNCT07068594
The Application of Virtual Reality Goggles During the First Wound Dressing After Open Heart Surgery
A study testing Virtual Reality Goggles in people with Pain Management and Wound Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of virtual reality glasses, a non-pharmacological method used in pain and anxiety management in nursing practices, on the pain, anxiety, and vital parameters perceived by patients undergoing their first dressing change after open heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Wound Care, Heart Surgery
- What is being tested?
- Virtual Reality Goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jun 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who verbally or in writing agree to participate in the study,
- Are over 18 years of age,
- Have not been diagnosed with any psychiatric disorder and are not using psychiatric medication,
- Have no visual, auditory, or perceptual impairments,
- Are undergoing their first wound dressing change following open-heart surgery,
Who cannot join
- Patients who are unconscious,
- Individuals who have undergone two or more wound dressing changes after open-heart surgery,
- Patients who report pain due to any other condition,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University - Institute of Health Sciences
Aydin, Merkez, 09100
About this study
Official title: The Effect of Virtual Reality Application on Pain, Anxiety, and Vital Parameters During the First Dressing Change After Open Heart Surgery
The aim of this study is to examine the effect of virtual reality glasses, a non-pharmacological method used in pain and anxiety management in nursing practices, on the pain, anxiety, and vital parameters perceived by patients undergoing their first dressing change after open heart surgery. Additionally, the study aims to obtain information about the safety of the virtual reality application. The primary questions this study seeks to answer are as follows:
Does the virtual reality headset application reduce the pain participants feel during the procedure?
Read more
Does the application reduce participants' anxiety levels during the procedure?
Does the virtual reality application have a positive effect on vital signs (pulse, blood pressure, etc.)?
Do participants experience any side effects or medical problems during this application?
Researchers will compare the group that received virtual reality glasses during the first dressing change after open-heart surgery with the standard care (control group) to evaluate the effects of the intervention.
- Being tested
- Virtual Reality Goggles
- Keywords
- virtual reality, pain, anxiety, heart surgery, wound dressing, vital signs, nursing, intensive care unit nursing, surgical nursing
- Medical subject headings
- Agnosia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GogglesDevice
A device consisting of glasses placed on the head of patients in the intervention group and earphones attached to the glasses
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses During the First Dressing Change Usage | Experimental | In this group, virtual reality glasses were used during the procedure for individuals who would have their first dressing changed on the first postoperative day after open heart surgery. Receives: Device: Virtual Reality Goggles |
| Standard Dressing Procedure without VR | No intervention | A standard dressing change procedure was performed on this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Pain intensity will be assessed using the Visual Analog Scale (VAS). It is a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain). Measurements were taken before the dressing procedure and 10 minutes after the procedure.
Measured: Immediately before the dressing procedure and 10 minutes after the procedure
Secondary outcomes (1)
Anxiety level
Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The inventory consist of 20 items rated on a 4 point Likert scale ranging from 1 (not at all), to 4 (very much so). The state anxiety subscale will be pre and post intervention to evaluate changes in situational anxiety levels.
Measured: Immediately before the dressing procedure and 10 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jan 2024
- Primary completion15 Jan 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almira Gurcan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068594
- Sponsor's protocol ID
- OHSFP2025-01
- Other IDs
- NoSecondaryID01
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Pain, Anxiety, and Vital Parameters During the First Dressing Change After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07068594
- Acronym / sponsor ID
- OHSFP2025-01
- Keywords
- virtual reality, pain, anxiety, heart surgery, wound dressing, vital signs, nursing, intensive care unit nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 16 Jul 2025 (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.
The aim of this study is to examine the effect of virtual reality glasses, a non-pharmacological method used in pain and anxiety management in nursing practices, on the pain, anxiety, and vital parameters perceived by patients undergoing their first dressing change after open heart surgery. Additionally, the study aims to obtain information about the safety of the virtual reality application. The primary questions this study seeks to answer are as follows:
Does the virtual reality headset application reduce the pain participants feel during the procedure?
Does the application reduce participants' anxiety levels during the procedure?
Does the virtual reality application have a positive effect on vital signs (pulse, blood pressure, etc.)?
Do participants experience any side effects or medical problems during this application?
Researchers will compare the group that received virtual reality glasses during the first dressing change after open-heart surgery with the standard care (control group) to evaluate the effects of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses During the First Dressing Change Usage | Experimental | Device: Virtual Reality GogglesIn this group, virtual reality glasses were used during the procedure for individuals who would have their first dressing changed on the first postoperative day after open heart surgery. |
| Standard Dressing Procedure without VR | No intervention | –A standard dressing change procedure was performed on this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who verbally or in writing agree to participate in the study,
- Are over 18 years of age,
- Have not been diagnosed with any psychiatric disorder and are not using psychiatric medication,
- Have no visual, auditory, or perceptual impairments,
- Are undergoing their first wound dressing change following open-heart surgery,
Key exclusion criteria (3 listed)
- Patients who are unconscious,
- Individuals who have undergone two or more wound dressing changes after open-heart surgery,
- Patients who report pain due to any other condition,
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 GogglesA device consisting of glasses placed on the head of patients in the intervention group and earphones attached to the glasses | Device | Virtual Reality Glasses During the First Dressing Change Usage |
Primary outcome
Pain Severity
Time frame: Immediately before the dressing procedure and 10 minutes after the procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS). It is a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain). Measurements were taken before the dressing procedure and 10 minutes after the procedure.
1 secondary outcome
Anxiety level
Time frame: Immediately before the dressing procedure and 10 minutes after the procedure
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Goggles in people with Pain Management and Wound Care, run by Aydin Adnan Menderes 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 5 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 20 Jul 2025. 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 Severity (time frame: Immediately before the dressing procedure and 10 minutes after the procedure). 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 20 Jul 2025.