Viewing Study NCT00310986



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00310986
Status: UNKNOWN
Last Update Posted: 2010-05-28
First Post: 2006-04-04

Brief Title: Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder
Sponsor: Khon Kaen University
Organization: Khon Kaen University

Study Overview

Official Title: Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children A Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2009-08
Last Known Status: RECRUITING
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: None
Brief Summary: In 2004 the Developmental Clinic of the Child Psychiatric Unit at Srinagarind Hospital had 80 new pediatric cases of attention deficit hyperactivity disorder ADHD come for evaluation and intervention The children were between 7-12 years of age Most of them were treated with stimulant medication ie methylphenidate to help reduce hyperactivity however both the parents and children needed special help to develop some techniques for behavioural management

Meditation has been used as an attention training method for many thousands of years and was mostly involved with religious or spiritual practices in various parts of the world especially in the eastern countries Breathing meditation is a popular method which can be applied to all people without instructions that are too complicated If meditation therapy by breathing meditation which is specified to treat attention deficit hyperactivity disorders benefits this group of patients it would be very useful culturally appropriate cost-effective and would reduce the drugs used which will save the child from drug side effects
Detailed Description: Attention Deficit Hyperactivity Disorder ADHD is the most common psychiatric disorder in children with an estimated prevalence of 3-7 in school children Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision DSM-IV-TR The major symptoms of this disorder are developmentally inconsistent and chronic levels of inattention impulsiveness and hyperactivity

The numbers of patients visiting physicians for ADHD are increasing from year to year Boys are diagnosed with ADHD three times more often than girls Although the studies on adolescents are few the data suggest that about half of the children diagnosed with ADHD will have persistent symptoms into adolescence and some symptoms persist into adulthood

The symptoms of ADHD if not adequately managed will have many life long effects on the patients families friends peers teachers and colleagues For the patients the disorder will impact on patients academic social and emotional performance and behavioural development leading to poor academic achievement low occupational status increased risk of substance abuse and delinquency More than 30 of children with ADHD repeat a year in school and up to 56 require remedial tutoring

Drug therapy began in the 1930s since the 1970s stimulants such as dexamphetamine and methylphenidate have increasingly been used as the treatment of choice but remain controversial Currently available psychological treatments for ADHD include behavioural training for teachers and parents and parenting skills classes behavioural therapy for children with ADHD Psychosocial treatments are generally combined with medication because each treatment alone has only a partial effect on the core symptoms of the disorder

Growing scientific evidence clinical experience and community attitudes are encouraging a shift to more natural and holistic forms of therapy as alternatives or adjuncts to pharmacological approaches in a variety of conditions Meditation has a wide range of applications but it is especially useful in treating stress and related disorders to promote calmness and enhance the attentional ability A psychological oriented definition stated that meditation is a set of attentional practices leading to an altered state or trait of consciousness characterized by expanded awareness greater presence and a more integrated sense of self

Breathing Meditation could be classified as both concentrative meditation and mindfulness meditation The concentrative ability is first developed at the beginning state and followed by mindful ability

The studies which use meditation therapy for ADHD are still scarce In Thailand Hassasiri A et al 1995 had developed meditation program for children with ADHD based on Neo-humanist concept which comprised of meditation and imagery The program was tested in pre-post test design with purposive sampling and yielded the statistical significant different at p 005 unpublished data There has never been research about the effectiveness of breathing meditation We are interested in conducting a randomized controlled trial to study the effectiveness in patients with attention deficit hyperactivity disorder

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None