Not Yet RecruitingN/AOther

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease

Sponsored by Fondation Hôpital Saint-Joseph

NCT ID
NCT06373627
Target Enrollment
104 participants
Start Date
2024-05-02
Est. Completion
2025-05-03

About This Study

The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.

Conditions Studied

Procedural PainCongenital Heart DiseaseHeart SurgeryHypnosis

Interventions

  • Hypnosis
  • Conventional medications used for sedation-analgesia
  • Medications used in addition to hypnosis

Eligibility

Age:6 Years - 18 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Patients aged ⩾ 6 years and \<18 years.
* Postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal).
* Patients affiliated with or benefiting from a social security or similar scheme.
* Oral consent obtained from minor children
* Written consent from the minor's legal representatives

Exclusion Criteria:

* Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
* Absence of at least 1 legal representative of the minor child
* French not understood

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Sébastien HASCOËT
CONTACT
0140942429s.hascoet@ghpsj.fr
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source