Actively Recruiting
Evaluation of an Anxiety Reducing Tool During Thyroid Biopsies: A Randomized Controlled Trial
Led by Nova Scotia Health Authority · Updated on 2025-02-18
300
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using stress balls can reduce anxiety in patients undergoing thyroid biopsies performed under local anesthetic. This open-label, randomized controlled trial compares patients who use stress balls during their biopsy to those who do not. Thyroid biopsies were chosen because they are common procedures done without sedation, allowing clear assessment of anxiety without confounding effects. Patients are randomly assigned to either hold a foam stress ball in each hand during their biopsy or to receive no stress ball. Before the procedure, all participants complete a questionnaire measuring baseline anxiety using a visual analog scale (VAS). After the biopsy, they complete another questionnaire assessing their anxiety during the procedure and their general tendency to feel anxious. Those in the stress ball group also report whether they felt the stress balls helped reduce their anxiety. Participants will be asked to fill out these questionnaires immediately before and after the biopsy, with the total time between them about 115 minutes. Researchers will analyze changes in anxiety levels, considering age and sex, to determine if stress balls reduce anxiety by at least 15% on the VAS. The study also collects qualitative feedback on other anxiety-reducing ideas and monitors for any allergic reactions to the stress ball material. The trial results will be shared with healthcare professionals to inform future anxiety management during procedures.
CONDITIONS
Brief Title
Evaluation of an Anxiety Reduction Tool During Thyroid Biopsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing thyroid biopsy under local anesthetic
- Able to provide consent for treatment and the research study
You will not qualify if you...
- Previous thyroid biopsy experience
- More than one thyroid lesion requiring biopsy
- Known allergy or sensitivity to stress ball material or cleaning solutions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Approximately 2 hours on the day of the biopsy procedure
Participants undergo a thyroid biopsy procedure during which some receive stress balls to help reduce anxiety, while others do not. Participants complete a pre-procedure anxiety questionnaire immediately after consent and a post-procedure anxiety questionnaire upon arrival in the recovery area.
1 procedure visit with pre- and post-procedure questionnaires
Trial Site Locations
Total: 1 location
1
Nova Scotia Health
Halifax, Nova Scotia, Canada
Actively Recruiting
Research Team
R
Robert Abraham, MD, FRCPC
C
Cassidy Singh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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