- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550323
Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure
Göğüs Tüpü Çıkarma İşlemi Sırasında Sanal Gerçeklik Uygulamasının Ağrı, Anksiyete ve Konfora Etkisi
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group using virtual reality glasses
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.
|
Group using virtual reality glasses: During the procedure, individuals will wear glasses.
|
|
No Intervention: Group not using virtual reality glasses
Standard protocols will be applied to this group and no action will be taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
5 month
|
|
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.
|
5 month
|
|
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 |
5 month
|
|
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".
|
5 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VRA15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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