The Effect of Virtual Reality Applications

NCT06792929 | Completed

• 1 other identifier: DICLE-ARDASURUCU-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ultrasound; Virtual Reality Therapy; Fine Needle Aspiration Biopsy; Thyroid Nodule (Diagnosis)

Keywords

Virtual Reality Therapy; Ultrasound; Thyroid Nodule; Fine needle aspiration biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.

• The Beck Anxiety Inventory (BAI)

  Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.

Study Arms (2)

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.

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.

Interventions

Virtual reality headset DEVICE

Participants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.

Virtual reality (VR) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment or psychiatric conditions that would interfere with study participation or the use of a virtual reality headset.

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Gaziantep City Hospital

Gaziantep, South East, 27100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Nodule; Disease

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of participants and study personnel was not feasible. Statistical analyses were performed by an independent statistician blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants were randomly assigned to either a virtual reality (VR) intervention group or a standard care control group.

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 27, 2025
• Study Start: January 19, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)