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

NCT02690194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-12-21

Study results available
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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.

Conditions

Interventions

DEVICE

Placebo Group

The placebo group will wear headphones and listen to nature sounds.

DEVICE

Buddhify Therapy

The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.

Sponsors & Collaborators

Principal Investigators

  • Gianmichel Corrado, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-10
Completion
2017-01-10

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02690194 on ClinicalTrials.gov