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Patient Anxiety During Radiological Examination

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hand Massage
Sponsored by
Midwestern Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No Massage

    Hand Massage

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 8, 2015
    Last Updated
    December 1, 2016
    Sponsor
    Midwestern Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496533
    Brief Title
    Patient Anxiety During Radiological Examination
    Official Title
    The Prevalence of Anxiety in Patients Undergoing Radiologic Exam
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Midwestern Regional Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    217 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No Massage
    Arm Type
    No Intervention
    Arm 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 Title
    Hand Massage
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hand Massage
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change in Anxiety as Measured by Visual Analog Scale
    Description
    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.
    Time Frame
    Baseline and After Imaging
    Secondary Outcome Measure Information:
    Title
    Change in Blood Pressure in mmHg
    Description
    A trained clinician will measure and record the subject's blood pressure using standard practices.
    Time Frame
    Baseline and After Imaging
    Title
    Change in Respiration Rate in Breaths Per Minute
    Description
    A trained clinician will measure and record the subject's respiration rate using standard practices.
    Time Frame
    Baseline and After Imaging
    Title
    Change in Pulse Rate
    Description
    A trained clinician will measure and record the subject's radial pulse rate using standard practices.
    Time Frame
    Baseline and After Imaging

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessica Kapustin, RN-C
    Organizational Affiliation
    Midwestern Regional Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Anxiety During Radiological Examination

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