Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06358612 |
| Other study ID # |
DALNSHA2024ABR001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
August 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Nova Scotia Health Authority |
| Contact |
Robert Abraham, MD, FRCPC |
| Phone |
902-473-2368 |
| Email |
radiology.research[@]dal.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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
