About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18
Subjects undergoing thyroid biopsies under local anesthetic that can provide consent to treatment and for the research study.
Disqualifiers
Previous biopsy experience
Greater than one (1) thyroid lesion requiring biopsy
Known allergy or sensitivity to stress ball material or cleaning solutions.
Trial design
Parallel
Treatments tested in this trial
Stress Balls
Other interventionPatients in the experimental arm will receive a foam stress ball to squeeze during their biopsy procedure.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Changes in stress ball efficacy based on anxiety during "routine" medical procedures, using VAS
Changes in stress ball efficacy depending on the subject's self-perceived anxiety when undergoing other "routine" medical procedures, including dental procedures, intramuscular injections, and phlebotomy. Measured based on individual response to VAS for each medical procedure in question (horizontal rating along 100 mm scale, ranging from 0 mm \["not at all anxious"\] to 100 mm \["extremely anxious"\]). Information collected here will be included in the multiple linear regression model to determine the effects of these two covariates on the primary outcome.
Changes in stress ball efficacy based on self-perceived anxiety, using VAS
Changes in stress ball efficacy depending on the degree to which a subject considers themselves to be an anxious person. Measured based on individual response to VAS asking the degree to which subject considers themselves to be an anxious person (horizontal rating along 100 mm scale, ranging from 0 mm \["not at all anxious"\] to 100 mm \["extremely anxious"\]). Information collected here will be included in the multiple linear regression model to determine the effects of these two covariates on the primary outcome.
Changes in stress ball efficacy based on age and sex, using questionnaire questions
Changes in stress ball efficacy depending on subject age and sex. Data collected by individual response to questionnaire. Information collected here will be included in the multiple linear regression model to determine the effects of these two covariates on the primary outcome.
Subject self-perceived change in anxiety
The following question will be collected and used for descriptive statistics only: Whether subjects will report any self-perceived change in anxiety when provided a stress ball during their procedure, regardless of the average population results (binary yes/no question). This data will be collected via questionnaire.
Sponsors and contacts
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