Patient Anxiety During Radiological Examination

NCT02496533 | Completed Phase 2 Results

• 1 other identifier: MRMC14-14
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

No Massage

NO INTERVENTION

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.

Hand Massage

EXPERIMENTAL

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

Interventions

Hand Massage PROCEDURE

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.

Hand Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age ≥ 18 years
• Scheduled to undergo radiologic imaging evaluation of a tumor

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Jessica Kapustin, RN-C
• Organization: Midwestern Regional Medical Center, Inc.

Jessica.Kapustin@CTCA-Hope.com

Study Officials

• Jessica Kapustin, RN-C

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN Survivorship

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 30, 2017
• Results First Posted: November 29, 2016

Record last verified: 2016-12