Patient Anxiety During Radiological Examination

The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Procedure: Hand Massage

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Massage; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Midwestern Regional Medical Center
• Investigators: Principal Investigator: Jessica Kapustin, RN-C, Midwestern Regional Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MRMC14-14