Trial Outcomes & Findings for Patient Anxiety During Radiological Examination (NCT NCT02496533)
NCT ID: NCT02496533
Last Updated: 2017-01-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
217 participants
Primary outcome timeframe
Baseline and After Imaging
Results posted on
2017-01-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
112
|
|
Overall Study
COMPLETED
|
102
|
106
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lack of data on outcome
|
3
|
0
|
|
Overall Study
Patient did not complete all measures
|
0
|
4
|
|
Overall Study
Late for radiologic testing
|
0
|
2
|
Baseline Characteristics
Patient Anxiety During Radiological Examination
Baseline characteristics by cohort
| Measure |
Hand Massage
n=105 Participants
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.
|
No Massage
n=112 Participants
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.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age ≥18 years
|
105 participants
n=5 Participants
|
112 participants
n=7 Participants
|
217 participants
n=5 Participants
|
|
Gender
Female
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Gender
Male
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
112 participants
n=7 Participants
|
217 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and After ImagingPopulation: All patients completing the study per protocol were included in the analysis.
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.
Outcome measures
| Measure |
Hand Massage
n=102 Participants
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.
|
No Massage
n=106 Participants
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.
|
|---|---|---|
|
Change in Anxiety as Measured by Visual Analog Scale
After Imaging
|
1.6 units on a scale
Standard Deviation 2.4
|
1.9 units on a scale
Standard Deviation 2.5
|
|
Change in Anxiety as Measured by Visual Analog Scale
Baseline
|
3.4 units on a scale
Standard Deviation 3.5
|
2.1 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and After ImagingPopulation: All patients completing the study per protocol were included in the analysis.
A trained clinician will measure and record the subject's blood pressure using standard practices.
Outcome measures
| Measure |
Hand Massage
n=102 Participants
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.
|
No Massage
n=106 Participants
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.
|
|---|---|---|
|
Change in Blood Pressure in mmHg
Systolic Blood Pressure Baseline
|
132.9 mmHg
Standard Deviation 17.6
|
129.9 mmHg
Standard Deviation 19.9
|
|
Change in Blood Pressure in mmHg
Systolic Blood Pressure After Imaging
|
135.1 mmHg
Standard Deviation 16.7
|
136.9 mmHg
Standard Deviation 20.4
|
|
Change in Blood Pressure in mmHg
Diastolic Blood Pressure Baseline
|
74.9 mmHg
Standard Deviation 10.3
|
75.1 mmHg
Standard Deviation 10.8
|
|
Change in Blood Pressure in mmHg
Diastoloc Blood Pressure After Imaging
|
72.6 mmHg
Standard Deviation 10.2
|
74.7 mmHg
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Baseline and After ImagingPopulation: All patients completing the study per protocol were included in the analysis.
A trained clinician will measure and record the subject's respiration rate using standard practices.
Outcome measures
| Measure |
Hand Massage
n=102 Participants
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.
|
No Massage
n=106 Participants
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.
|
|---|---|---|
|
Change in Respiration Rate in Breaths Per Minute
Respiration Rate Baseline
|
17.2 breaths per minute
Standard Deviation 2.8
|
17.2 breaths per minute
Standard Deviation 2.5
|
|
Change in Respiration Rate in Breaths Per Minute
Respiration Rate After Imaging
|
16.6 breaths per minute
Standard Deviation 2.5
|
17.5 breaths per minute
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and After ImagingPopulation: All patients completing the study per protocol were included in the analysis.
A trained clinician will measure and record the subject's radial pulse rate using standard practices.
Outcome measures
| Measure |
Hand Massage
n=102 Participants
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.
|
No Massage
n=106 Participants
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.
|
|---|---|---|
|
Change in Pulse Rate
Pulse Rate Baseline
|
78.3 beats per minute
Standard Deviation 14.6
|
80.6 beats per minute
Standard Deviation 14.2
|
|
Change in Pulse Rate
Pulse Rate After Imaging
|
77.0 beats per minute
Standard Deviation 14.0
|
80.1 beats per minute
Standard Deviation 15.1
|
Adverse Events
Hand Massage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Massage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place