The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

Patient Anxiety During Radiological Examination

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source Midwestern Regional Medical Center
Brief Summary

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.

Overall Status Completed
Start Date February 2014
Completion Date January 2015
Primary Completion Date January 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Anxiety as Measured by Visual Analog Scale Baseline and After Imaging
Secondary Outcome
Measure Time Frame
Change in Blood Pressure in mmHg Baseline and After Imaging
Change in Respiration Rate in Breaths Per Minute Baseline and After Imaging
Change in Pulse Rate Baseline and After Imaging
Enrollment 217
Condition
Intervention

Intervention type: Procedure

Intervention name: Hand Massage

Description: 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.

Arm group label: Hand Massage

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jessica Kapustin, RN-C Principal Investigator Midwestern Regional Medical Center
Verification Date

December 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Jessica Kapustin

Investigator title: RN Survivorship

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: No Massage

Arm group type: No Intervention

Description: 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.

Arm group label: Hand Massage

Arm group type: Experimental

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov