The Effect of Virtual Reality Applications
August 11, 2026 updated by: Hamdiye ARDA SÜRÜCÜ, Dicle University
Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-needle Aspiration Biopsy: an Open-label Randomized Controlled Trial
Thyroid nodules are a common health problem in the adult population.
Ultrasound-guided fine-needle aspiration biopsy (FNAB) is the standard diagnostic procedure for evaluating suspected thyroid nodules.
Although FNAB is generally considered a safe and minimally invasive procedure, it may cause pain, anxiety, and fear.
In addition, patients are instructed not to speak or cough during the procedure, and the biopsy may need to be repeated if an insufficient specimen is obtained, which can further increase psychological distress.
Therefore, effective non-pharmacological interventions may help improve patient comfort during the procedure.
Distraction is a widely used non-pharmacological pain management strategy that reduces patients' perception of pain and distress by redirecting their attention away from the procedure.
Virtual reality (VR) is an immersive distraction technique that has shown promise in reducing procedure-related discomfort in various clinical settings.
This open-label randomized controlled trial aimed to evaluate the effect of virtual reality on pain as the primary outcome and anxiety and fear of pain as secondary outcomes in patients undergoing ultrasound-guided fine-needle aspiration biopsy of suspected thyroid nodules.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research Type:
This study was designed as an open-label randomized controlled trial with blinded statistical analysis. Statistical analyses were performed by an independent statistician who was blinded to group allocation.
Research Population and Sample:
The study population consisted of patients presenting to Gaziantep City Hospital with suspected thyroid nodules. The sample consisted of 100 patients who met the inclusion criteria and were scheduled to undergo thyroid fine-needle aspiration biopsy.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South East
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Gaziantep, South East, Turkey (Türkiye), 27100
- Gaziantep City Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with a suspected thyroid nodule scheduled to undergo ultrasound-guided fine-needle aspiration biopsy.
- No history of dizziness or vestibular disorders.
- No visual impairment that would interfere with the use of a virtual reality headset.
Exclusion Criteria:
• Cognitive impairment or psychiatric conditions that would interfere with study participation or the use of a virtual reality headset.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality (VR) group
Participants wore a virtual reality headset displaying an immersive underwater nature video accompanied by relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.
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Participants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.
|
|
No Intervention: Standard care group
Participants underwent the ultrasound-guided fine-needle aspiration biopsy procedure under standard care without virtual reality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
The Visual Analogue Scale (VAS) is a 10-cm (100-mm) scale used to assess pain intensity.
Scores range from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.
Assessments were performed approximately 15 minutes before the ultrasound-guided fine-needle aspiration biopsy procedure and approximately 15 minutes after completion of the procedure.
|
Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Fear of Pain Questionnaire-III (FPQ-III)
Time Frame: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
The Fear of Pain Questionnaire-III (FPQ-III) is a 30-item instrument assessing fear of pain across three domains: severe pain, minor pain, and medical pain.
Items are scored on a 5-point Likert scale, yielding a total score ranging from 30 to 150, with higher scores indicating greater fear of pain.
Assessments were performed approximately 15 minutes before the ultrasound-guided fine-needle aspiration biopsy procedure and approximately 15 minutes after completion of the procedure.
|
Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
|
The Beck Anxiety Inventory (BAI)
Time Frame: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms.
Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.
Assessments were performed approximately 15 minutes before the ultrasound-guided fine-needle aspiration biopsy procedure and approximately 15 minutes after completion of the procedure.
|
Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2025
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
January 18, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
January 27, 2025
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DICLE-ARDASURUCU-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.