Patient Anxiety During Radiological Examination

Study Overview
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Brief Summary
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This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer patients as they undergo radiological examination to evaluate tumor response. Anxiety levels will be investigated before massage, after massage, and following the completion of the radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will be used to measure anxiety.

Official Title
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The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: Hand Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Age ≥ 18 years Scheduled to undergo radiologic imaging evaluation of a tumor Exclusion Criteria: Known hand injury within 30 days prior to study participation Known pregnancy Mental disability as determined by the treating physician Actively receiving radiation therapy Actively receiving chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Massage<br>Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure. | |
| Experimental: Hand Massage<br>Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure. | Procedure: Hand Massage<br>* The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety as Measured by Visual Analog Scale | Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging. | Baseline and After Imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure in mmHg | A trained clinician will measure and record the subject's blood pressure using standard practices. | Baseline and After Imaging | 
| Change in Respiration Rate in Breaths Per Minute | A trained clinician will measure and record the subject's respiration rate using standard practices. | Baseline and After Imaging | 
| Change in Pulse Rate | A trained clinician will measure and record the subject's radial pulse rate using standard practices. | Baseline and After Imaging |