Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-04-23 @ 10:41 PM
Study NCT ID:
NCT02496533
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2015-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Anxiety During Radiological Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jessica.Kapustin@CTCA-Hope.com', 'title': 'Jessica Kapustin, RN-C', 'organization': 'Midwestern Regional Medical Center, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hand Massage', '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.\n\nHand 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.", 'otherNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Massage', '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.', 'otherNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Anxiety as Measured by Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'OG001', 'title': 'No Massage', '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'After Imaging', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.8', 'pValueComment': 'No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.', 'groupDescription': 'H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After Imaging', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients completing the study per protocol were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure in mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'OG001', 'title': 'No Massage', '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.'}], 'classes': [{'title': 'Systolic Blood Pressure Baseline', 'categories': [{'measurements': [{'value': '132.9', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '129.9', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure After Imaging', 'categories': [{'measurements': [{'value': '135.1', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '136.9', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure Baseline', 'categories': [{'measurements': [{'value': '74.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Diastoloc Blood Pressure After Imaging', 'categories': [{'measurements': [{'value': '72.6', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.', 'groupDescription': 'H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.09', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.', 'groupDescription': 'H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's blood pressure using standard practices.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients completing the study per protocol were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Respiration Rate in Breaths Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'OG001', 'title': 'No Massage', '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.'}], 'classes': [{'title': 'Respiration Rate Baseline', 'categories': [{'measurements': [{'value': '17.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Respiration Rate After Imaging', 'categories': [{'measurements': [{'value': '16.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.009', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.', 'groupDescription': 'H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's respiration rate using standard practices.", 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients completing the study per protocol were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'OG001', 'title': 'No Massage', '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.'}], 'classes': [{'title': 'Pulse Rate Baseline', 'categories': [{'measurements': [{'value': '78.3', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Pulse Rate After Imaging', 'categories': [{'measurements': [{'value': '77.0', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.45', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.', 'groupDescription': 'H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's radial pulse rate using standard practices.", 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients completing the study per protocol were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'FG001', 'title': 'No Massage', '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lack of data on outcome', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient did not complete all measures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Late for radiologic testing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hand Massage', '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.\n\nHand 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."}, {'id': 'BG001', 'title': 'No Massage', '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age ≥18 years', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2015-07-08', 'resultsFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-07', 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Anxiety as Measured by Visual Analog Scale', 'timeFrame': 'Baseline and After Imaging', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Blood Pressure in mmHg', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's blood pressure using standard practices."}, {'measure': 'Change in Respiration Rate in Breaths Per Minute', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's respiration rate using standard practices."}, {'measure': 'Change in Pulse Rate', 'timeFrame': 'Baseline and After Imaging', 'description': "A trained clinician will measure and record the subject's radial pulse rate using standard practices."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥ 18 years\n* Scheduled to undergo radiologic imaging evaluation of a tumor\n\nExclusion Criteria:\n\n* Known hand injury within 30 days prior to study participation\n* Known pregnancy\n* Mental disability as determined by the treating physician\n* Actively receiving radiation therapy\n* Actively receiving chemotherapy'}, 'identificationModule': {'nctId': 'NCT02496533', 'briefTitle': 'Patient Anxiety During Radiological Examination', 'organization': {'class': 'OTHER', 'fullName': 'Midwestern Regional Medical Center'}, 'officialTitle': 'The Prevalence of Anxiety in Patients Undergoing Radiologic Exam', 'orgStudyIdInfo': {'id': 'MRMC14-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Massage', '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Hand Massage', '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.', 'interventionNames': ['Procedure: Hand Massage']}], 'interventions': [{'name': 'Hand Massage', 'type': 'PROCEDURE', '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.", 'armGroupLabels': ['Hand Massage']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jessica Kapustin, RN-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwestern Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwestern Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN Survivorship', 'investigatorFullName': 'Jessica Kapustin', 'investigatorAffiliation': 'Midwestern Regional Medical Center'}}}}