Transcendental Meditation or Hypnotherapy versus Standard Medical Care for the Treatment of Children with Primary Headaches: a Multi-Centre, Pragmatic, Randomized Clinical Study

Completed

Conditions: migraine
Tension-type headache
10019231

Registration Number: NL-OMON38283

Lead Sponsor: ouis Bolk Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 141

Inclusion Criteria

•Children attending a paediatrician/ paediatric neurologist
•Written informed consent by patients and parents
•Children age 9-18 years
•Suffering from primary headache (according to ICHD-2 criteria)
•Headache attack frequency: >2 times per month
•Ability to understand and speak the Dutch language
•Accessible by phone and internet

Exclusion Criteria

•Epilepsy or other serious neurological disease
•Previous treatment with hypnotherapy or meditation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•Mean frequency of primary headache attacks: will be noted in a headache diary<br /><br>(4 weeks)<br /><br>•Percentage of children with a > 50% reduction in mean frequency of headache<br /><br>attacks after the 3-month intervention and 9 month follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•Mean headache severity and headache duration, associated symptoms and used<br /><br>pain medication:<br /><br>•Quality of life using the 50-item CHQ-PF50 (parent form)<br /><br>•Anxiety and depression scores using the Revised Children*s Anxiety and<br /><br>Depression Scale-short version (RCADS-25)<br /><br>•Coping with pain using the 37-item Dutch Pain Coping Questionnaire (PCQ)<br /><br>•Somatisation scores using the Children Somatisation Inventory (CSI)<br /><br>•Sense of Coherence using the 13-item Dutch Sense of Coherence questionnaire<br /><br>for children (SOC-K)<br /><br>•Compliance and satisfaction TM/HT/SMT<br /><br>•Adverse events</p><br>