Evaluation of an Anxiety Reduction Tool During Thyroid Biopsies

ConditionAnxiety State
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Stress Balls

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Stress BallsExperimental treatment 1 intervention
Group B: No Stress BallsNo intervention 0 interventions

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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