N/A N=54 Randomized Single-blind Treatment

A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.

Pain · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT02690194 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Dec 2018

Primary outcome: Primary: Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure — 121.9; 121.9; 127.3; 77.2 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Placebo Group (Device); Buddhify Therapy (Device)
Age: Pediatric, Adult, Older Adult · 14+ yrs
Sex: All
Sponsor: Boston Children's Hospital
Primary completion: Jan 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.