CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Placebo Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02690194
NCT02690194N/ACompleted
CompareCT.gov

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

Boston Children's Hospital·interventional·Posted Feb 24, 2016·Updated Dec 21, 2018

In Brief

A clinical study evaluating Placebo Group and Buddhify Therapy for Pain and Anxiety. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Anxiety
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 24, 2016
Enrollment StartAug 1, 2015
Primary CompletionJan 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.4 years ago

Interventions

Placebo Groupdevice

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

Buddhify Therapydevice

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.