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NCT03999320: SOPHRO CARE

Sophrology and Congenital Heart Disease

Completed NA Last updated 3 October 2023
What this trial tests

NA trial testing Sophrology sessions in Congenital Heart Disease in 200 participants. Completed in 19 September 2023.

Timeline
19 July 2019
Primary endpoint
19 September 2023
19 September 2023

Quick facts

Lead sponsorUniversity Hospital, Montpellier
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment200
Start date19 July 2019
Primary completion19 September 2023
Estimated completion19 September 2023
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 13 to 25, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The molecular mechanisms of cardiac development and related diseases.
    Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
  2. Physical activity interventions for people with congenital heart disease.
    Williams CA, Wadey C, Pieles G, Stuart G, et al · · 2020 · cited 40× · PMID 33112424 · DOI 10.1002/14651858.cd013400.pub2
  3. Impact of COVID-19 disease on clinical research in pediatric and congenital cardiology.
    Pommier V, Abassi H, Lavastre K, Calderon J, et al · · 2022 · cited 3× · PMID 35523633 · DOI 10.1016/j.arcped.2022.03.004
  4. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods.
    Moreau J, Lavastre K, Romieu H, Charbonnier F, et al · · 2020 · cited 2× · PMID 32154361 · DOI 10.1016/j.ijcha.2020.100489
  5. Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial.
    Moreau J, Neyraud C, Huguet H, Andrianoely M, et al · · 2026 · PMID 42052946 · DOI 10.1093/eurjcn/zvag115

Verify or expand the search:

Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03999320.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing