Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06358612

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility assessment

Treatment

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

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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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