Virtual Reality TherapyNCT06792929
The Effect of Virtual Reality Applications
A study testing Virtual reality headset in people with Virtual Reality Therapy and Ultrasound, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality Therapy, Ultrasound, Fine Needle Aspiration Biopsy
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2025to 30 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment or psychiatric conditions that would interfere with study participation or the use of a virtual reality headset.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep City Hospital
Gaziantep, South East, 27100
About this study
Official title: 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.
Read the 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.
- Conditions
- Virtual Reality Therapy, Ultrasound, Fine Needle Aspiration Biopsy, Thyroid Nodule (Diagnosis)
- Being tested
- Virtual reality headset
- Keywords
- Virtual Reality Therapy, Ultrasound, Thyroid Nodule, Fine needle aspiration biopsy
- Medical subject headings
- Thyroid Nodule, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Participants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) group | Experimental | 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. Receives: Device: Virtual reality headset |
| Standard care group | No intervention | Participants underwent the ultrasound-guided fine-needle aspiration biopsy procedure under standard care without virtual reality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
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.
Measured: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
Secondary outcomes (2)
The Fear of Pain Questionnaire-III (FPQ-III)
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.
Measured: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
The Beck Anxiety Inventory (BAI)
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.
Measured: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start19 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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 Virtual Reality TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either a virtual reality (VR) intervention group or a standard care control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdiye ARDA SÜRÜCÜ, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792929
- Sponsor's protocol ID
- DICLE-ARDASURUCU-003
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karadeniz E, Arda H, Arslan Cellat EG. Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-Needle Aspiration Biopsy: Open-Label Randomized Controlled Trial. J Med Internet Res. 2026 Oct 6;28:e103829. doi: 10.2196/103829.
PubMed 42837655
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-needle Aspiration Biopsy: an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06792929
- Acronym / sponsor ID
- DICLE-ARDASURUCU-003
- Conditions
- Virtual Reality Therapy, Ultrasound, Fine Needle Aspiration Biopsy, Thyroid Nodule (Diagnosis)
- Keywords
- Virtual Reality Therapy, Ultrasound, Thyroid Nodule, Fine needle aspiration biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Jan 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either a virtual reality (VR) intervention group or a standard care control group.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) group | Experimental | Device: Virtual reality headsetParticipants wore a virtual reality headset displaying an immersive underwater nature video accompanied by relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure. |
| Standard care group | No intervention | –Participants underwent the ultrasound-guided fine-needle aspiration biopsy procedure under standard care without virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Cognitive impairment or psychiatric conditions that would interfere with study participation or the use of a virtual reality headset.
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 headsetParticipants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure. | Device | Virtual reality (VR) group |
Primary outcome
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.
2 secondary outcomes
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 Beck Anxiety Inventory (BAI)
Time frame: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
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 17 Sep 2026.
- Derived from this study: PubMed 42837655Karadeniz E, Arda H, Arslan Cellat EG. Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-Needle Aspiration Biopsy: Open-Label Randomized Controlled Trial. J Med Internet Res. 2026 Oct 6;28:e103829. doi: 10.2196/103829.
- Individual participant dataSharing planned: No
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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 Virtual reality headset in people with Virtual Reality Therapy and Ultrasound, run by Dicle 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 3 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 17 Sep 2026. 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?
Visual Analogue Scale (time frame: Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.). 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 NCT06792929, 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 17 Sep 2026.