Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures

Anxiety State Clinical Trial

Official title: Evaluation of an Anxiety Reducing Tool During Thyroid and Prostate Biopsy Procedures: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. 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.

Clinical Trial Description

Study Design This is a prospective, open-label randomized controlled trial. Given the nature of the intervention, it is not possible to blind participants and the health providers to the treatment group that they are randomized to. We have chosen to conduct a randomized controlled trial as stress balls are not currently a standard offering during IR procedures, and implementing the intervention is relatively simple with minimal to no additional risk to participants in the treatment group. Thyroid biopsies and prostate biopsies have been selected as the procedures for this study as these are performed on a regular basis and are conducted solely under local anesthetic without the potentially confounding effect of sedation.

Variables Independent variables: "stress ball" (SB) or "no stress ball" (nSB) Dependent variable: intraprocedural anxiety level Moderating variables: age, sex, previous biopsy experience

Measures and Materials Visual Analogue Scale (VAS) Questionnaires 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 10 cm horizontal rating scale, along which subjects indicate with a tick the point that they feel best represents their state at a specified time. In this study, subjects receive a pre-procedure questionnaire and post-procedure questionnaire consisting of VAS questions among other entries. Questionnaires will also collect subject age (not specific DOB), sex, and previous biopsy experience for stratified analyses.

The pre-procedure questionnaire is designed to determine baseline anxiety. It consists exclusively of VAS questions. The first question assesses the subject's current level of anxiety in anticipation of their biopsy, while the last three assess their anxiety while undergoing "routine" medical procedures.

The post-procedure questionnaire is designed to determine intraprocedural anxiety. It consists of two VAS questions: one to assess their anxiety during the procedure, and one to assess the degree to which they consider themselves an anxious person. Subjects are also offered to comment on any interventions they think could have reduced their anxiety. Questionnaires given to subjects in the SB group also has a binary yes/no question to determine whether the subject felt that the stress balls reduced their stress during the procedure.

Questionnaire pairs (pre- and post-procedure) will be pre-randomized into either the SB or nSB groups using randomization software (Random.org) and assigned a study number A-XXX (e.g., A-001). The questionnaire will directly indicate which group a participant is in. The radiologist will take questionnaires from the top of a stack for each subject.

Stress Balls

Subjects in the SB group will receive two 5.1 cm (2 in) diameter yellow foam stress ball Procedure:

The radiologist performing the biopsy will ask eligible patients on arrival whether they are willing to participate in a trial investigating anxiety during biopsy procedures, and that it would entail a short questionnaire before and after the procedure where they will indicate their stress level. The patient will be informed that a non-invasive method or tool may be used during the procedure and has no harmful effects. Formal written consent will be obtained, at which point the subject will be enrolled in the study. All subjects will fill out the pre-procedure VAS to assess their baseline anxiety level. No identifying personal health information beyond age and sex will be captured in the questionnaire.

Subjects in the SB group will receive a stress balls (in a protective plastic covering) to be held in each hand immediately prior to the procedure, and instructed to squeeze the balls whenever they feel uncomfortable or anxious. Subjects in the nSB group will not receive any intervention. After the procedure, stress balls will be taken from the SB group subjects, and all participants will fill out a post-procedure VAS questionnaire to assess their intraprocedural anxiety and to ask whether there are any similar interventions that they think would have improved their experience.

Data Collection Questionnaires will be collected and the investigator will collate responses and input numerical information from each response into a password-protected Excel spreadsheet housed on a password-protected USB drive to safeguard data from tampering. No personal health information other than age and sex will be recorded.

Statistical Analysis Anxiety levels will be described with means and proportions as appropriate. Significance of differences between groups will be determined by a two-sided test. Further analysis will be done to elucidate any stratified differences based on sex, age, as well as effects due to previous biopsy experience. Comparisons will not be made between patients undergoing thyroid or prostate biopsy; rather, these groups will be analyzed separately and in parallel.

Hypotheses:

• Null hypothesis (H₀): There is no significant difference in anxiety levels between the two groups (SB and nSB).

• Alternative Hypothesis (H₁): There is a significant difference in anxiety levels between the two groups.

Data Collection and Preparation:

• Collect anxiety scores from a minimum of 100 patients using a standardized visual analog scale (VAS).

• The data will be organized into two groups: one for SB and one for nSB.

Assumptions for t-Test:

• The data should follow a normal distribution (approximately).

• The variances of the two groups should be homogeneous (similar).

• Since we have two independent groups, we will use a two-sample t-test.

Critical Value and p-Value:

• α = 0.05 and compare it with the calculated t-statistic.

• p-value = 0.05.

Decision:

• If the p-value is less than the chosen significance level (α), reject the null hypothesis.

• Otherwise, fail to reject the null hypothesis.

Interpretation:

• If we reject the null hypothesis, conclude that there is a statistically significant difference in anxiety levels between the two interventions.

Reporting:

• Results will be reported with appropriate confidence intervals and effect sizes ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

• NCT number: NCT06358612
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Contact: Robert Abraham, MD, FRCPC
• Phone: 902-473-2368
• Email: radiology.research@dal.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: August 31, 2025