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Sophrology and Congenital Heart Disease

NCT03999320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-03

No results posted yet for this study

Summary

The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease.

Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.

Conditions

  • Congenital Heart Disease

Interventions

OTHER

Sophrology sessions

8 sophrology sessions, approximately 60 minutes each, spread over 12 months

OTHER

usual care

usual care

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Sophie GUILLAUMONT, MD · Saint Pierre Institut

  • Yves DULAC, MD · UH Toulouse

  • Damien BONNET, MD · APHP Necker

  • Alban Louen BARUTEAU, Professor · UH Nantes

  • Pascal AMEDRO, MD · UH Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2023-09-19
Completion
2023-09-19

Countries

  • France

Study Locations

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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 NCT03999320 on ClinicalTrials.gov