- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704008
The Effect of Virtual Reality Glasses Applied to Hemodialysis Patients on Vital Signs and Anxiety Level
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was designed and conducted as a randomized controlled experimental study to determine the effects of virtual reality glasses on the vital signs and anxiety levels of hemodialysis patients.
The study population consisted of patients diagnosed with kidney failure who received hemodialysis at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2023 and May 2024. A total of 56 patients who volunteered to participate and met the inclusion criteria were included in the study. These patients were randomly assigned to two homogeneous groups according to gender and type of renal failure (acute/chronic): an experimental group (n=28) and a control group (n=28).
Patients in the experimental group watched a 4K virtual reality video featuring natural scenery accompanied by relaxing background music through virtual reality glasses during hemodialysis, whereas patients in the control group received standard hemodialysis care without any additional intervention.
Data were collected using the Patient Information Form, Vital Signs Follow-up Form, Visual Analog Scale for Pain (VAS), State Anxiety Scale, and Visual Analog Scale for Satisfaction (VAS-Satisfaction). Ethics committee approval, institutional permission, and written informed consent were obtained before the study was conducted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving hemodialysis treatment for the first time.
- Age ≥18 years.
- No visual, hearing, or cognitive impairment.
- Able to communicate effectively.
- Clinically stable.
- No diagnosed psychiatric disorder or use of psychiatric medication.
- No history of seizures.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Previous hemodialysis treatment.
- Age <18 years.
- Visual, hearing, or cognitive impairment.
- History of kidney transplantation.
- Communication difficulties.
- Diagnosed psychiatric disorder or use of psychiatric medication.
- History of seizures.
- Declined to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
Participants received a virtual reality intervention during hemodialysis in addition to standard care.
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Participants wore virtual reality glasses at the start of the hemodialysis session and viewed a 4K nature video with calming background music for 15 minutes.
The intervention was administered once during the hemodialysis session in addition to standard hemodialysis care.
Participants received routine hemodialysis care according to the standard clinical practice of the dialysis unit without any additional intervention.
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Active Comparator: Control Group
Participants received standard hemodialysis care without any additional intervention.
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Participants received routine hemodialysis care according to the standard clinical practice of the dialysis unit without any additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in systolic blood pressure measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in Diastolic Blood Pressure
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in diastolic blood pressure measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in Heart Rate
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in heart rate measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in Respiratory Rate
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in respiratory rate measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in Peripheral Oxygen Saturation (SpO₂)
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in peripheral oxygen saturation (SpO₂) measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in Body Temperature
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in body temperature measured before and after the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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State Anxiety Level After Hemodialysis
Time Frame: Immediately after completion of the hemodialysis session.
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State anxiety measured using the State Anxiety Inventory (STAI-State), a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.
Assessment was performed immediately after completion of the hemodialysis session.
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Immediately after completion of the hemodialysis session.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pain Score
Time Frame: Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Change in pain score measured using the Visual Analog Scale for Pain (VAS-P), a 0-10 scale where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain.
Pain was assessed before and immediately after completion of the hemodialysis session.
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Baseline (before the hemodialysis session) and immediately after completion of the hemodialysis session.
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Participant Satisfaction Score
Time Frame: Immediately after completion of the hemodialysis session.
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Participant satisfaction with the virtual reality intervention measured using the Visual Analog Scale for Satisfaction (VAS-S), a 0-10 scale where 0 indicates not satisfied at all and 10 indicates completely satisfied.
Higher scores indicate greater participant satisfaction.
Assessment was performed immediately after completion of the hemodialysis session.
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Immediately after completion of the hemodialysis session.
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Collaborators and Investigators
Investigators
- Study Director: Hilal Tüzer, Assoc. Prof., Ankara Yildirim Beyazıt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBU-2023-208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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