Chest Tube RemovalNCT06550323
Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure
A study testing Group using virtual reality glasses in people with Chest Tube Removal, run by Hale Rumeysa Seçer at 1 site in Turkey (Türkiye).
Trial summary
Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Tube Removal
- What is being tested?
- Group using virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 30 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Study Inclusion Criteria:
- Must be between the ages of 18-65,
- Must have undergone coronary artery bypass graft surgery and have a chest tube,
- Must participate in the study voluntarily,
- Must not have vision or hearing problems,
- Must not have disorientation in place and time,
- Must not have any psychiatric disorders,
- Study Exclusion Criteria:
- Those with chronic pain and routinely using painkillers,
- Those using painkillers before the procedure,
- Those with problems such as migraine, vertigo, dizziness,
- Patients using prescription glasses and those having vision problems without glasses were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Göğüs Tüpü Çıkarma İşlemi Sırasında Sanal Gerçeklik Uygulamasının Ağrı, Anksiyete ve Konfora Etkisi
Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.
- Conditions
- Chest Tube Removal
- Being tested
- Group using virtual reality glasses
- Keywords
- virtual reality, pain, anxiety, comfort
- 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.
Group using virtual reality glassesDevice
Group using virtual reality glasses: During the procedure, individuals will wear glasses.
| Study group | Role | What they receive |
|---|---|---|
| Group using virtual reality glasses | Experimental | Virtual reality application will be applied to this group and virtual reality glasses will be put on 5 minutes before the procedure and the video will be started to be watched during the process. Receives: Device: Group using virtual reality glasses |
| Group not using virtual reality glasses | No intervention | Standard protocols will be applied to this group and no action will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
To evaluate pain severity, pain results are evaluated by scoring between 0-10. While 0 indicates "No pain", 10 indicates "Unbearable pain".
The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result
Measured: 5 month
State-Trait Anxiety Inventory Scale
It is a 4-point Likert-type scale with 40 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. anxiety level will be determined.
Measured: 5 month
comfort scale
It is a scale ranging from 0 to 10 points. While 0 points indicate 'most comfortable', 10 points indicate 'most uncomfortable'.
The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result
Measured: 5 month
verbal pain scale
0 points indicate "No pain", 1 point indicates "Mild pain", 2 points indicate "Moderate pain" and 3 points indicate "Severe pain".
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start20 Mar 2023
- Primary completion25 Jul 2024
- Study completion30 Aug 2024 (estimated)
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 Chest Tube RemovalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hale Rumeysa Seçer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hale Rumeysa Seçer, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550323
- Sponsor's protocol ID
- VRA15
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Secer H, Yayla A. The effects of virtual reality on pain, anxiety, and comfort during the chest tube removal procedure: A randomized clinical trial. Complement Ther Clin Pract. 2025 Feb;58:101931. doi: 10.1016/j.ctcp.2024.101931. Epub 2024 Nov 8.
PubMed 39541838
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Göğüs Tüpü Çıkarma İşlemi Sırasında Sanal Gerçeklik Uygulamasının Ağrı, Anksiyete ve Konfora Etkisi
- ClinicalTrials.gov ID
- NCT06550323
- Acronym / sponsor ID
- VRA15
- Conditions
- Chest Tube Removal
- Keywords
- virtual reality, pain, anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hale Rumeysa SeçerUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 13 Aug 2024 (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.
Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group using virtual reality glasses | Experimental | Device: Group using virtual reality glassesVirtual reality application will be applied to this group and virtual reality glasses will be put on 5 minutes before the procedure and the video will be started to be watched during the process. |
| Group not using virtual reality glasses | No intervention | –Standard protocols will be applied to this group and no action will be taken. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Group using virtual reality glassesGroup using virtual reality glasses: During the procedure, individuals will wear glasses. | Device | Group using virtual reality glasses |
Primary outcome
visual analog scale
Time frame: 5 month
To evaluate pain severity, pain results are evaluated by scoring between 0-10. While 0 indicates "No pain", 10 indicates "Unbearable pain". The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result
State-Trait Anxiety Inventory Scale
Time frame: 5 month
It is a 4-point Likert-type scale with 40 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. anxiety level will be determined.
comfort scale
Time frame: 5 month
It is a scale ranging from 0 to 10 points. While 0 points indicate 'most comfortable', 10 points indicate 'most uncomfortable'. The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result
verbal pain scale
Time frame: 5 month
0 points indicate "No pain", 1 point indicates "Mild pain", 2 points indicate "Moderate pain" and 3 points indicate "Severe pain".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 39541838Secer H, Yayla A. The effects of virtual reality on pain, anxiety, and comfort during the chest tube removal procedure: A randomized clinical trial. Complement Ther Clin Pract. 2025 Feb;58:101931. doi: 10.1016/j.ctcp.2024.101931. Epub 2024 Nov 8.
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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 Group using virtual reality glasses in people with Chest Tube Removal, run by Hale Rumeysa Seçer 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?
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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. 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?
Results are not available in the source record.
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: 5 month). 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?
On the ClinicalTrials.gov record for NCT06550323, 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 13 Aug 2024.