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The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

NCT ID: NCT01716351

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-02-28

Brief Summary

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Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of life in ICD patients. The specialized, real-time data, collected by the device provides a unique look at the electrophysiological parameters of each patient's heart.

Detailed Description

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All intervention data will be analyzed to determine the statistical significance of the data, and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental interviews with patients who have lived with the implantable cardioverter defibrillator (ICD) device for at least six months and who are not in the intervention. The qualitative data gathered from these interviews will document concepts of illness and healing and general beliefs about mind-body interventions.

Conditions

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Cardiac Arrhythmias

Keywords

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Randomized Clinical Control Trial Complementary and Alternative Medicine Yoga Electrophysiology Implantable Cardioverter Defibrillator Psychosocial Anxiety Self-Compassion Anti-Tachycardia Pacing Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Adapted Yoga Intervention Group

Patients received the Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients and a call from a cardiac research nurse once monthly for five months.

Group Type EXPERIMENTAL

Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Intervention Type BEHAVIORAL

A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.

Control

Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
* Must be 18 or more years of age

Exclusion Criteria

* Patients requiring more than 48 hours of hospitalization for implantation
* Mental Incompetence (Dementia)
* Physician's contra-indication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Stefanie Toise

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefanie CF Toise, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale New Haven Hospital, St. Raphael Campus

Thomas J Donohue, MD

Role: STUDY_DIRECTOR

Yale New Haven Hospital, St. Raphael Campus

Other Identifiers

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F31AT003757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#SR-1569

Identifier Type: -

Identifier Source: org_study_id