Patient Anxiety During Radiological Examination

Phase 2

Completed

• Conditions: Anxiety
• Interventions: Procedure: Hand Massage

• Registration Number: NCT02496533
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Results First Submitted: 2016-01-08
• Results First Submitted QC: 2016-10-07
• Results First Posted: 2016-11-29
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand Massage	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.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety as Measured by Visual Analog Scale	Baseline and After Imaging	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.

Secondary Outcome Measures

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