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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Kapustin, RN-C | Midwestern Regional Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients completing the study per protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and After Imaging |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Kapustin, RN-C | Midwestern Regional Medical Center, Inc. | Jessica.Kapustin@CTCA-Hope.com |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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 |
| Late for radiologic testing |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
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| Secondary | Change in Blood Pressure in mmHg | A trained clinician will measure and record the subject's blood pressure using standard practices. | All patients completing the study per protocol were included in the analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and After Imaging |
|
|
|
|
| Secondary | Change in Respiration Rate in Breaths Per Minute | A trained clinician will measure and record the subject's respiration rate using standard practices. | All patients completing the study per protocol were included in the analysis. | Posted | Mean | Standard Deviation | breaths per minute | Baseline and After Imaging |
|
|
|
|
| Secondary | Change in Pulse Rate | A trained clinician will measure and record the subject's radial pulse rate using standard practices. | All patients completing the study per protocol were included in the analysis. | Posted | Mean | Standard Deviation | beats per minute | Baseline and After Imaging |
|
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | 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. | 0 | 112 | 0 | 112 |
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| Diastolic Blood Pressure Baseline |
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| Diastoloc Blood Pressure After Imaging |
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H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging. |
| ANOVA |
| <0.09 |
No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed. |
| No |
| Superiority or Other |