Evaluation of an Anxiety Reduction Tool During Thyroid Biopsies

NCT06358612 | Recruiting

• 1 other identifier: DALNSHA2024ABR001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing thyroid biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after their procedure. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool.

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

• Change in anxiety level of greater than 15% based on Visual Analog Score (VAS)

  The VAS is a simple and easy to administer test, and has been validated for the assessment of self-perceived psychological outcomes such as pain and anxiety. The VAS consists of a continuous 100 mm horizontal rating scale, along which subjects indicate with a tick the point that they feel best represents their state at a specified time, from "not at all anxious" at 0 mm to "extremely anxious" at 100 mm. For each response, a number from 0mm - 100mm will be measured, rounded to the nearest millimeter. In this study, subjects receive a pre-procedure questionnaire and post-procedure questionnaire consisting of VAS questions among other entries.

  1 year

Secondary Outcomes (5)

• Changes in stress ball efficacy based on anxiety during "routine" medical procedures, using VAS

  1 year

• Changes in stress ball efficacy based on self-perceived anxiety, using VAS

  1 year

• Changes in stress ball efficacy based on age and sex, using questionnaire questions

  1 year

• Subject self-perceived change in anxiety

  1 year

• Subject opinion on helpful anxiety-reducing methods

  1 year

Study Arms (2)

Stress Balls

EXPERIMENTAL

Patients given a stress ball in each hand.

Other: Stress Balls

No Stress Balls

NO INTERVENTION

Patients NOT given a stress ball in each hand.

Interventions

Stress Balls OTHER

Patients in the experimental arm will receive a foam stress ball to squeeze during their biopsy procedure.

Stress Balls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Subjects undergoing thyroid biopsies under local anesthetic that can provide consent to treatment and for the research study.

You may not qualify if:

• Previous biopsy experience
• Greater than one (1) thyroid lesion requiring biopsy
• Known allergy or sensitivity to stress ball material or cleaning solutions.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Robert J Abraham, MD, FRCPC

  Nova Scotia Health Authority/Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Abraham, MD, FRCPC

CONTACT

902-473-2368; radiology.research@dal.ca

Cassidy Singh

CONTACT

902-473-2368; Cassidy.Singh@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: December 1, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)