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Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder

NCT05741307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-09-12

No results posted yet for this study

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 (T0+6 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 (T0+8 weeks): after a wash-out period of 2 weeks (usual treatment only) for both groups
* T3 (T0+14 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.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

BEHAVIORAL

Self-hypnosis application

The Hypnotidoo application offers screenless self-hypnosis sessions for 5-12 year olds. Each session lasts 6 to 8 minutes and focuses on one of the following themes: stress and anxiety, sleep, daily troubles and discomforts, hypersensitivity, hyperactivity and difficulty concentrating, self-confidence, difficult life events, anger. Each session begins with breathing and refocusing work, followed by self-hypnosis through stories and metaphors suitable for children. The application will be used by patients in the context of research for 6 weeks, 5 days out of 7 in parallel with the usual treatment.

OTHER

Questionnaires

Before and after (at T0, T1, T2 and T3) the 6-week period of use of the application and a wash-out period of 2 weeks (= usual treatment only), self- and hetero-questionnaires which constitute the gold standard for evaluating the symptoms of inattention and anxiety are proposed: Conners III, Child Behavior Checklist (CBCL) and Revised-Children's Manifest Anxiety Scale (R-CMAS). * T0: inclusion * T1: 6 weeks after T0 (inclusion) * T2: 2 weeks after T1 * T3: 6 weeks after T2

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Catherine Grosmaitre, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2024-06-23
Completion
2024-06-23

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 NCT05741307 on ClinicalTrials.gov