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OpenTrials
Completed

NCT Number: NCT06792929

The Effect of Virtual Reality Applications

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep City Hospital

Gaziantep, South East, 27100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Immediately before and immediately 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 immediately before and immediately after the ultrasound-guided fine-needle aspiration biopsy procedure.

Secondary outcomes

  1. The Fear of Pain Questionnaire-III (FPQ-III)

    Time frame: Immediately before and immediately 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 immediately before and immediately after the ultrasound-guided fine-needle aspiration biopsy procedure.

  2. The Beck Anxiety Inventory (BAI)

    Time frame: Immediately before and immediately 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 immediately before and immediately after the ultrasound-guided fine-needle aspiration biopsy procedure.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-needle Aspiration Biopsy: an Open-label Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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