Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
Launched by FONDATION HÔPITAL SAINT-JOSEPH · Apr 15, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to help manage pain for children with congenital heart disease who need to have their thoracic drains removed after heart surgery. The researchers want to see if using therapeutic hypnosis, combined with a small amount of medication to help them relax and feel less pain, is just as effective as using higher doses of medication. If successful, this approach could help reduce the amount of medicine used, which may lead to fewer side effects for the kids.
To participate in this study, children aged 6 to 17 who have had heart surgery and have drains in their chest may be eligible. They will need to have permission from their legal guardians and be able to understand the process. During the trial, participants can expect to receive either the hypnosis method or the standard higher dose of medication while their drain is being removed. It’s important to know that this trial is not yet recruiting participants, so it’s still in the planning stages.
Gender
ALL
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
About Fondation Hôpital Saint Joseph
Fondation Hôpital Saint-Joseph is a dedicated clinical trial sponsor committed to advancing healthcare and improving patient outcomes through innovative research. Located in a reputable healthcare institution, the foundation collaborates with healthcare professionals and researchers to conduct high-quality clinical trials across various medical fields. By fostering a culture of scientific excellence and patient-centered care, Fondation Hôpital Saint-Joseph aims to contribute valuable insights to the medical community and enhance the quality of treatments available to patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Edouard CHAMBON
Principal Investigator
Fondation Hôpital Saint-Joseph
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported