- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06792942
Effect of a Nature-View Curtain on Pain, Anxiety, and Fear During Thyroid Biopsy
Effect of a Nature-View Curtain Used as a Distraction Method on Pain, Anxiety, and Fear During Ultrasound-Guided Thyroid Fine-Needle Aspiration Biopsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Adana, Turkey (Türkiye), 01230
- Adana City Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Suspicion of a mass in the thyroid
- No vision problems
Exclusion Criteria:
- Mental health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature-View Curtain Group
Participants underwent routine ultrasound-guided thyroid fine-needle aspiration biopsy and were instructed to focus throughout the procedure on a ceiling-mounted, 195 × 135 cm curtain displaying a nature scene.
The procedure lasted approximately 5 to 10 minutes.
|
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.
|
|
No Intervention: Standard-Care Control Group
Participants underwent routine ultrasound-guided thyroid fine-needle aspiration biopsy without nature-view curtain distraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Beck Anxiety Inventory (BAI)
Time Frame: 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.
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Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
|
Fear of Pain Questionnaire-III (FPQ-III)
Time Frame: 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.
|
Approximately 15 minutes before and approximately 15 minutes after the ultrasound-guided fine-needle aspiration biopsy procedure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Mental Disorders
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Thyroid Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Procedural
- Anxiety Disorders
- Thyroid Nodule
- Disease
Other Study ID Numbers
- DICLE-ARDASURUCU-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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