Fine Needle Aspiration Biopsy, Thyroid Nodule (Diagnosis), Ultrasound, Virtual Reality Therapy
Conditions
Keywords
Virtual Reality Therapy, Ultrasound, Thyroid Nodule, Fine needle aspiration biopsy
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.
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.
Interventions
DEVICEVirtual reality headset
Participants wore a virtual reality headset displaying an immersive underwater nature video with relaxing music throughout the ultrasound-guided fine-needle aspiration biopsy procedure.
Sponsors
Dicle University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants were randomly assigned to either a virtual reality (VR) intervention group or a standard care control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| The Beck Anxiety Inventory (BAI) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed