Phase 2
Completed N=217
Patient Anxiety During Radiological Examination
Source: ClinicalTrials.gov NCT02496533 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Change in Anxiety as Measured by Visual Analog Scale — 3.4; 2.1; 1.6; 1.9 units on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anxiety as Measured by Visual Analog Scale |
3.4; 2.1; 1.6; 1.9 | <0.001 sig |
| SECONDARY Change in Blood Pressure in mmHg |
132.9; 129.9; 135.1; 136.9; 74.9; 75.1 | <0.02 sig |
| SECONDARY Change in Respiration Rate in Breaths Per Minute |
17.2; 17.2; 16.6; 17.5 | <0.009 sig |
| SECONDARY Change in Pulse Rate |
78.3; 80.6; 77.0; 80.1 | <0.45 |
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
Data sourced from ClinicalTrials.gov (NCT02496533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.