Recruiting

Anxiety Reduction Tool

Sponsor:

Nova Scotia Health Authority

Code:

NCT06358612

Conditions

Anxiety State

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stress Balls

Study Details

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

Study ID

NCT06358612

Start date

Dec 1, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 20, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Stress Balls

Patients given a stress ball in each hand.

no intervention: No Stress Balls

Patients NOT given a stress ball in each hand.

Interventions

Stress Balls

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

Primary outcome measure

  • Change in anxiety level of greater than 15% based on Visual Analog Score (VAS) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-18.