Thyroid Nodule (Diagnosis)
Conditions
Keywords
Thyroid Fine-Needle Aspiration Biopsy, Visual Distraction, Nature-View Curtain, Procedural Pain, Anxiety, Fear of Pain, Nonpharmacological Intervention
Brief summary
Thyroid fine-needle aspiration biopsy (FNAB) may cause procedure-related pain, anxiety, and fear. This randomized controlled trial evaluated whether visual distraction with a nature-view curtain could reduce these outcomes. A total of 100 adults undergoing ultrasound-guided thyroid FNAB were randomly assigned in a 1:1 ratio to a nature-view curtain group or a standard-care control group. Participants in the intervention group were instructed to focus on a ceiling-mounted nature-view curtain throughout the biopsy, whereas participants in the control group underwent routine biopsy without this visual distraction. Pain intensity was the primary outcome; anxiety and fear of pain were secondary outcomes. Outcomes were assessed approximately 15 minutes before and approximately 15 minutes after the procedure.
Detailed description
This completed, two-arm, parallel-group, randomized controlled trial was conducted at Adana City Training and Research Hospital in Adana, Türkiye, between June 1, 2025, and February 28, 2026. The study included 100 adults scheduled to undergo ultrasound-guided thyroid fine-needle aspiration biopsy because of a suspected thyroid nodule or mass. Participants were stratified by sex and assigned in a 1:1 ratio to the nature-view curtain group or the standard-care control group using blocks of two. Within each sex stratum, the first participant in each block was assigned by coin toss, and the second was allocated to the other group. Both groups underwent routine ultrasound-guided thyroid fine-needle aspiration biopsy. Participants in the intervention group were instructed to focus throughout the procedure on a ceiling-mounted, 195 × 135 cm curtain displaying a nature scene. Participants in the control group underwent the routine biopsy procedure without nature-view curtain distraction. The biopsy procedure lasted approximately 5 to 10 minutes. Pain intensity, anxiety, and fear of pain were assessed approximately 15 minutes before and approximately 15 minutes after the procedure. Pain intensity assessed using the Visual Analog Scale was the primary outcome. Anxiety assessed using the Beck Anxiety Inventory and fear of pain assessed using the Fear of Pain Questionnaire-III were secondary outcomes. Because of the nature of the intervention, participants and study personnel were not masked. Statistical analyses were conducted by an independent statistician who received coded group data and was unaware of the group identities.
Interventions
BEHAVIORALNature-View Curtain Visual Distraction
Visual distraction was provided by instructing participants to focus on a ceiling-mounted curtain displaying a nature scene throughout the ultrasound-guided thyroid fine-needle aspiration biopsy procedure.
Sponsors
Dicle University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the intervention, masking of participants and study personnel was not feasible. Statistical analyses were performed by an independent statistician who received a coded dataset and was blinded to the group identities.
Intervention model description
This was a two-arm, parallel-group, randomized controlled trial with pre-intervention and post-intervention assessments. Participants were stratified by sex and assigned in a 1:1 ratio to the nature-view curtain group or the control group using blocks of two. Within each sex stratum, the first participant in each block was assigned by coin toss, and the second was allocated to the other group. Both groups underwent routine ultrasound-guided thyroid fine-needle aspiration biopsy; only the intervention group was instructed to focus on the nature-view curtain during the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspicion of a mass in the thyroid * No vision problems
Exclusion criteria
* Mental health problems
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 |
|---|---|---|
| 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