Gaziantep City Hospital
Gaziantep, South East, 27100, Turkey (Türkiye)
NCT Number: NCT06792929
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Gaziantep, South East, 27100, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.
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.
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.
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.
Dicle University
Other
Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-needle Aspiration Biopsy: an Open-label Randomized Controlled Trial
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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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