Anxiety
Conditions
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.
Interventions
PROCEDUREHand 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.
Sponsors
Midwestern Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 105 |
| 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. | 112 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of data on outcome | 3 | 0 |
| Overall Study | Late for radiologic testing | 0 | 2 |
| Overall Study | Patient did not complete all measures | 0 | 4 |
Baseline characteristics
| Characteristic | Hand Massage | No Massage | Total |
|---|---|---|---|
| Age, Customized Age ≥18 years | 105 participants | 112 participants | 217 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 105 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Gender Female | 43 Participants | 46 Participants | 89 Participants |
| Gender Male | 62 Participants | 66 Participants | 128 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) White | 75 Participants | 86 Participants | 161 Participants |
| Region of Enrollment United States | 105 participants | 112 participants | 217 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 112 |
| serious Total, serious adverse events | 0 / 105 | 0 / 112 |
Outcome results
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.
Time frame: Baseline and After Imaging
Population: All patients completing the study per protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand Massage | Change in Anxiety as Measured by Visual Analog Scale | Baseline | 3.4 units on a scale | Standard Deviation 3.5 |
| Hand Massage | Change in Anxiety as Measured by Visual Analog Scale | After Imaging | 1.6 units on a scale | Standard Deviation 2.4 |
| No Massage | Change in Anxiety as Measured by Visual Analog Scale | Baseline | 2.1 units on a scale | Standard Deviation 2.6 |
| No Massage | Change in Anxiety as Measured by Visual Analog Scale | After Imaging | 1.9 units on a scale | Standard Deviation 2.5 |
Comparison: 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.p-value: <0.001ANOVA
Secondary
Change in Blood Pressure in mmHg
A trained clinician will measure and record the subject's blood pressure using standard practices.
Time frame: Baseline and After Imaging
Population: All patients completing the study per protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand Massage | Change in Blood Pressure in mmHg | Systolic Blood Pressure Baseline | 132.9 mmHg | Standard Deviation 17.6 |
| Hand Massage | Change in Blood Pressure in mmHg | Systolic Blood Pressure After Imaging | 135.1 mmHg | Standard Deviation 16.7 |
| Hand Massage | Change in Blood Pressure in mmHg | Diastolic Blood Pressure Baseline | 74.9 mmHg | Standard Deviation 10.3 |
| Hand Massage | Change in Blood Pressure in mmHg | Diastoloc Blood Pressure After Imaging | 72.6 mmHg | Standard Deviation 10.2 |
| No Massage | Change in Blood Pressure in mmHg | Diastoloc Blood Pressure After Imaging | 74.7 mmHg | Standard Deviation 11.3 |
| No Massage | Change in Blood Pressure in mmHg | Systolic Blood Pressure Baseline | 129.9 mmHg | Standard Deviation 19.9 |
| No Massage | Change in Blood Pressure in mmHg | Diastolic Blood Pressure Baseline | 75.1 mmHg | Standard Deviation 10.8 |
| No Massage | Change in Blood Pressure in mmHg | Systolic Blood Pressure After Imaging | 136.9 mmHg | Standard Deviation 20.4 |
Comparison: 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.p-value: <0.02ANOVA
Comparison: H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.p-value: <0.09ANOVA
Secondary
Change in Pulse Rate
A trained clinician will measure and record the subject's radial pulse rate using standard practices.
Time frame: Baseline and After Imaging
Population: All patients completing the study per protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand Massage | Change in Pulse Rate | Pulse Rate Baseline | 78.3 beats per minute | Standard Deviation 14.6 |
| Hand Massage | Change in Pulse Rate | Pulse Rate After Imaging | 77.0 beats per minute | Standard Deviation 14 |
| No Massage | Change in Pulse Rate | Pulse Rate Baseline | 80.6 beats per minute | Standard Deviation 14.2 |
| No Massage | Change in Pulse Rate | Pulse Rate After Imaging | 80.1 beats per minute | Standard Deviation 15.1 |
Comparison: H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.p-value: <0.45ANOVA
Secondary
Change in Respiration Rate in Breaths Per Minute
A trained clinician will measure and record the subject's respiration rate using standard practices.
Time frame: Baseline and After Imaging
Population: All patients completing the study per protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand Massage | Change in Respiration Rate in Breaths Per Minute | Respiration Rate Baseline | 17.2 breaths per minute | Standard Deviation 2.8 |
| Hand Massage | Change in Respiration Rate in Breaths Per Minute | Respiration Rate After Imaging | 16.6 breaths per minute | Standard Deviation 2.5 |
| No Massage | Change in Respiration Rate in Breaths Per Minute | Respiration Rate Baseline | 17.2 breaths per minute | Standard Deviation 2.5 |
| No Massage | Change in Respiration Rate in Breaths Per Minute | Respiration Rate After Imaging | 17.5 breaths per minute | Standard Deviation 2.4 |
Comparison: H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.p-value: <0.009ANOVA