Pain; Catheter (Other)NCT07027917
The Application of Virtual Reality Goggles During Pleural Catheter Insertion
A study testing Virtual Reality Goggles in people with Pain; Catheter (Other), run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of virtual reality glasses applied to individuals who will undergo pleural catheter placement on pain, anxiety, and vital parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain; Catheter (Other)
- 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
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 12 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written or verbal consent to participate, Being over 18 years of age, Not having any psychiatric diagnosis, Not having any problems with vision, hearing, perception or communication.
Who cannot join
- Being unconscious Experiencing pain due to any other problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes Üniversitesi
Aydin, Merkez, 09010
About this study
Official title: The Impact of Virtual Reality Application on Pain, Anxiety, and Vital Parameters During Pleural Catheter Insertion: A Randomized Controlled Trial
The aim of this study is to examine the effects of virtual reality glasses applied to individuals who will undergo pleural catheter placement on pain, anxiety, and vital parameters. The main research questions that the study aims to answer are as follows:
- Does the application of virtual reality goggles have an effect on pain measured during pleural catheter insertion?
- Does the application of virtual reality goggles have an effect on anxiety measured during pleural catheter insertion?
- Does the application of virtual reality goggles have an effect on the vital parameters measured during pleural catheter insertion?
The researcher compared the intervention and control groups to determine whether the glasses have an effect on the measurable parameters (pain, anxiety, and vital signs).
Read the detailed description
Today, both pharmacological and non-pharmacological methods are used to reduce patients' pain and anxiety during invasive procedures. Distraction techniques hold an important place among non-pharmacological methods. Virtual reality (VR) glasses can be effective in reducing perceived pain and anxiety by allowing patients to divert their attention elsewhere during procedures.
This study was conducted to evaluate the distribution of virtual reality brightness on patients' pain and anxiety levels.
The study was designed as a randomized controlled trial by the researchers. The patients included in the study were divided into two groups: the intervention group (exposed to virtual reality) and the control group (standard care). Following stratified randomization, randomization was carried out using a simple random number table.
Application:
During the insertion phase, Shinecon brand virtual reality glasses were placed on the patients during the connection process, and underwater images were shown.
During routine phases, no distraction method was applied, and only the procedure was followed.
All patients' vital signs (blood pressure, heart rate, oxygen saturation) were recorded before, during, and after the procedure. Pain levels were assessed using the Visual Analog Scale (VAS) before and after the procedure. Additionally, anxiety levels were measured using the State-Trait Anxiety Inventory (STAI-S, STAI-T) before and after the procedure.
This study supports the use of virtual reality technology as a non-pharmacological intervention to improve patient comfort during minimally invasive procedures and provides evidence-based information.
- Conditions
- Pain; Catheter (Other)
- Being tested
- Virtual Reality Goggles
- Keywords
- pain, anxiety, nursing, pleural catheter, virtual reality, vital signs, state anxiety, VAS, VR
- Medical subject headings
- 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
VR
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Goggles During Catheterization | Experimental | In this group, virtual reality glasses were applied during the pleural catheter insertion procedure. Receives: Device: Virtual Reality Goggles |
| Standard Catheterization Without VR | No intervention | No additional intervention was applied to this group other than the routine catheter insertion procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain severity will be assessed using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain), measurements will be taken before, during and after pleural catheter insertion.
Measured: From immediately before to 10 minutes after catheter insertion
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: From immediately before to 10 minutes after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start30 Nov 2023
- Primary completion30 Nov 2023
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain; Catheter (Other)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT07027917
- Sponsor's protocol ID
- E-97594401-804.01-455320
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2025
- Last updated
- 19 Jun 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Application on Pain, Anxiety, and Vital Parameters During Pleural Catheter Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07027917
- Acronym / sponsor ID
- E-97594401-804.01-455320
- Conditions
- Pain; Catheter (Other)
- Keywords
- pain, anxiety, nursing, pleural catheter, virtual reality, vital signs, state anxiety, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 19 Jun 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 effects of virtual reality glasses applied to individuals who will undergo pleural catheter placement on pain, anxiety, and vital parameters. The main research questions that the study aims to answer are as follows:
- Does the application of virtual reality goggles have an effect on pain measured during pleural catheter insertion?
- Does the application of virtual reality goggles have an effect on anxiety measured during pleural catheter insertion?
- Does the application of virtual reality goggles have an effect on the vital parameters measured during pleural catheter insertion?
The researcher compared the intervention and control groups to determine whether the glasses have an effect on the measurable parameters (pain, anxiety, and vital signs).
Detailed description
Today, both pharmacological and non-pharmacological methods are used to reduce patients' pain and anxiety during invasive procedures. Distraction techniques hold an important place among non-pharmacological methods. Virtual reality (VR) glasses can be effective in reducing perceived pain and anxiety by allowing patients to divert their attention elsewhere during procedures.
This study was conducted to evaluate the distribution of virtual reality brightness on patients' pain and anxiety levels.
The study was designed as a randomized controlled trial by the researchers. The patients included in the study were divided into two groups: the intervention group (exposed to virtual reality) and the control group (standard care). Following stratified randomization, randomization was carried out using a simple random number table.
Application:
During the insertion phase, Shinecon brand virtual reality glasses were placed on the patients during the connection process, and underwater images were shown.
During routine phases, no distraction method was applied, and only the procedure was followed.
All patients' vital signs (blood pressure, heart rate, oxygen saturation) were recorded before, during, and after the procedure. Pain levels were assessed using the Visual Analog Scale (VAS) before and after the procedure. Additionally, anxiety levels were measured using the State-Trait Anxiety Inventory (STAI-S, STAI-T) before and after the procedure.
This study supports the use of virtual reality technology as a non-pharmacological intervention to improve patient comfort during minimally invasive procedures and provides evidence-based information.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Goggles During Catheterization | Experimental | Device: Virtual Reality GogglesIn this group, virtual reality glasses were applied during the pleural catheter insertion procedure. |
| Standard Catheterization Without VR | No intervention | –No additional intervention was applied to this group other than the routine catheter insertion procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written or verbal consent to participate, Being over 18 years of age, Not having any psychiatric diagnosis, Not having any problems with vision, hearing, perception or communication.
Key exclusion criteria (1 listed)
- Being unconscious Experiencing pain due to any other problem
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 GogglesVR | Device | Virtual Reality Goggles During Catheterization |
Primary outcome
Pain severity
Time frame: From immediately before to 10 minutes after catheter insertion
Pain severity will be assessed using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain), measurements will be taken before, during and after pleural catheter insertion.
1 secondary outcome
Anxiety level
Time frame: From immediately before to 10 minutes after catheter insertion
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 19 Jun 2025.
- Individual participant dataSharing planned: Yes
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; Catheter (Other), 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 1 inclusion and 1 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 19 Jun 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: From immediately before to 10 minutes after catheter insertion). 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 19 Jun 2025.