Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741307
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2022-11-03
Brief Title:
Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention DeficitHyperactivity Disorder
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effect of a Self-hypnosis Smartphone Application on Attention Disorders and Anxiety in Children With Attention DeficitHyperactivity Disorder ADHD
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPNAAX
Brief Summary:
The prevalence of Attention Deficit Hyperactivity ADHD varies between 3 and 10 depending on the studies Comorbidities are frequently associated in particular anxiety disorders School social and family consequences of ADHD can be major especially in the presence of a comorbidity
The study goal is to evaluate through questionnaires the effect of self-hypnosis via a smartphone application on the symptoms of inattention and anxiety in children with ADHD in addition to their treatment by methylphenidate Parents and children complete the study questionnaires four times
T0 at inclusion
T1 T06 weeks after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment after 6 weeks of usual treatment for the group 2
T2 T08 weeks after a wash-out period of 2 weeks usual treatment only for both groups
T3 T014 weeks after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment after 8 weeks of usual treatment for the group 1 following the 6 weeks of use of the application
The study goal is to evaluate through questionnaires the effect of self-hypnosis via a smartphone application on the symptoms of inattention and anxiety in children with ADHD in addition to their treatment by methylphenidate Parents and children complete the study questionnaires four times
T0 at inclusion
T1 T06 weeks after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment after 6 weeks of usual treatment for the group 2
T2 T08 weeks after a wash-out period of 2 weeks usual treatment only for both groups
T3 T014 weeks after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment after 8 weeks of usual treatment for the group 1 following the 6 weeks of use of the application
Detailed Description:
The prevalence of Attention Deficit Hyperactivity ADHD varies between 3 and 10 depending on the studies Comorbidities are frequently associated in particular anxiety disorders School social and family consequences of ADHD can be major especially in the presence of a comorbidity
The management of ADHD requires an effective multimodal approach to attention disorders and comorbid disorders In France the Haute Autorité de Santé recommends the combination of drug treatment with methylphenidate as a second line or for serious cases from the first line and a non-drug treatment such as behavioral therapies cognitive remediation and psycho-educational support
As part of this project and more generally for the care of young ADHD patients it is interesting to target a method that can be deployed in a relatively controlled way in addition to other non-drug measures and without contradicting them Hypnosis is a technique that is already widely used in the treatment of pain In the field of mental health the clinical use of hypnosis is a relevant strategy to support self-regulation capacities in anxious children Indeed this technique offers an easily accessible experience of reducing arousal and dissociating internal physical sensations and perceptions while promoting attentional focus towards the examination of new possibilities The repeated use of self-hypnosis incorporating imaginary exposure facilitates the feeling of capacity for action empowerment in the face of anxiety-provoking elements reduces hyper-reactivity and leads to the control of physiological reactivity
In France it is difficult for families to find structures for the care and monitoring of childs ADHD The lack of speech therapists the waiting list in public medical institution the cost of follow-up by private psychologists the lack of specialized structures are obstacles to care and increase the risk of pejorative evolution In this context the use at home by the child of a digitized self-hypnosis tool has all its interest
The objectives of the study are to evaluate through questionnaires the effect of self-hypnosis via a smartphone application on the symptoms of inattention and anxiety in children with ADHD in addition to taking classical pharmacological load by methylphenidate
Parents and children complete the study questionnaires four times
T0 at inclusion
T1 T06 weeks after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment after 6 weeks of usual treatment for the group 2
T2 T08 weeks after a wash-out period of 2 weeks usual treatment only for both groups
T3 T014 weeks after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment after 8 weeks of usual treatment for the group 1 following the 6 weeks of use of the application
The management of ADHD requires an effective multimodal approach to attention disorders and comorbid disorders In France the Haute Autorité de Santé recommends the combination of drug treatment with methylphenidate as a second line or for serious cases from the first line and a non-drug treatment such as behavioral therapies cognitive remediation and psycho-educational support
As part of this project and more generally for the care of young ADHD patients it is interesting to target a method that can be deployed in a relatively controlled way in addition to other non-drug measures and without contradicting them Hypnosis is a technique that is already widely used in the treatment of pain In the field of mental health the clinical use of hypnosis is a relevant strategy to support self-regulation capacities in anxious children Indeed this technique offers an easily accessible experience of reducing arousal and dissociating internal physical sensations and perceptions while promoting attentional focus towards the examination of new possibilities The repeated use of self-hypnosis incorporating imaginary exposure facilitates the feeling of capacity for action empowerment in the face of anxiety-provoking elements reduces hyper-reactivity and leads to the control of physiological reactivity
In France it is difficult for families to find structures for the care and monitoring of childs ADHD The lack of speech therapists the waiting list in public medical institution the cost of follow-up by private psychologists the lack of specialized structures are obstacles to care and increase the risk of pejorative evolution In this context the use at home by the child of a digitized self-hypnosis tool has all its interest
The objectives of the study are to evaluate through questionnaires the effect of self-hypnosis via a smartphone application on the symptoms of inattention and anxiety in children with ADHD in addition to taking classical pharmacological load by methylphenidate
Parents and children complete the study questionnaires four times
T0 at inclusion
T1 T06 weeks after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment after 6 weeks of usual treatment for the group 2
T2 T08 weeks after a wash-out period of 2 weeks usual treatment only for both groups
T3 T014 weeks after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment after 8 weeks of usual treatment for the group 1 following the 6 weeks of use of the application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01509-34 | OTHER | IDRCB Number | None |