N/A
Completed N=54
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
Source: ClinicalTrials.gov NCT02690194 ↗Enrolled (actual)
54
Serious AEs
—
Results posted
Dec 2018
Primary outcomePrimary: Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure — 121.9; 121.9; 127.3; 77.2 mmHg
Summary
The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure |
121.9; 121.9; 127.3; 77.2; 78.9; 82.2 | — |
| PRIMARY Pre-therapy/Pre-procedure Stress Level Measured by Pulse |
75.6; 66.4; 69.5 | — |
| PRIMARY Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate |
16.1; 14.0; 14.4 | — |
| PRIMARY Pre-therapy/Pre-procedure Anxiety Level |
33.1; 34.4; 31.4; 35.6; 34.0; 32.4 | — |
| SECONDARY Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse |
-0.11; 3.48 | — |
| SECONDARY Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate |
-0.14; -0.70 | — |
| SECONDARY Post-therapy/Pre-procedure Change in Anxiety Level |
-2.82; -12.3; -8.44; -3.92 | — |
| SECONDARY Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure |
3.9; -1.1; 7.0; -1.2 | — |
| SECONDARY Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale |
1.5; 1.9; 1.4 | — |
| SECONDARY Drink in Last Hour |
8; 4; 11; 8; 10; 8 | — |
| SECONDARY Eat in Last Hour |
13; 11; 12; 3; 3; 7 | — |
| SECONDARY Exercise in Last Hour |
16; 9; 17; 0; 5; 2 | — |
| SECONDARY Injection Experiences |
5; 5; 6; 10; 9; 13 | — |
| SECONDARY Number of Injections |
5.8; 5.2; 4.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT02690194). 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.