Effects of Virtual Reality on Pain, Anxiety, and Fear During Thyroid Fine-needle Aspiration Biopsy: an Open-label Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Visual Analogue Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant)
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Standard care group
Participants underwent the ultrasound-guided fine-needle aspiration biopsy procedure under standard care without virtual reality.
Virtual reality (VR) group
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.
Intervention: Virtual reality headset (Device)
Outcomes
Primary Outcomes
Visual Analogue Scale
Time Frame: Before and immediately after ultrasound guided fine needle aspiration biopsy procedure
The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means "I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administered two times.
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.
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.
Secondary Outcomes
- Fear of Pain Scale-III(Before and immediately after ultrasound guided fine needle aspiration biopsy procedure)
- Beck Anxiety Scale(Before and immediately after ultrasound guided fine needle aspiration biopsy procedure)
- The Fear of Pain Questionnaire-III (FPQ-III)(Immediately before and immediately after the ultrasound-guided fine-needle aspiration biopsy procedure)
- The Beck Anxiety Inventory (BAI)(Immediately before and immediately after the ultrasound-guided fine-needle aspiration biopsy procedure)
- 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.)
Investigators
Hamdiye ARDA SÜRÜCÜ
Professor
Dicle University