Transcendental Meditation or Hypnotherapy in children with primary headache.
- Conditions
- Primary headache, Migraine, Tension-type headache, Primaire hoofdpijn, spierspanningshoofdpijn
- Registration Number
- NL-OMON28446
- Lead Sponsor
- ouis Bolk Institute, Hoofdstraat 24 3972 LA Driebergen, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 141
Inclusion Criteria
1. Children attending a paediatrician/ paediatric neurologist;
2. Written informed consent by patients and parents;
Exclusion Criteria
1. Start of prophylactic medication for headache during the trial;
2. Epilepsy or other serious neurological disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean frequency of primary headache attacks: will be noted in a headache diary (4 weeks);<br /><br>2. Percentage of children with a > 50% reduction in mean frequency of headache attacks after the 3-month intervention and 9 month follow-up.
- Secondary Outcome Measures
Name Time Method 1. Mean headache severity and headache duration, associated symptoms and used pain medication;<br /><br>2. Quality of life using the 50-item CHQ-PF50 (parent form);<br /><br>3. Anxiety and depression scores using the Revised Children’s Anxiety and Depression Scale-short version (RCADS-25);<br /><br>4. Coping with pain using the 37-item Dutch Pain Coping Questionnaire (PCQ);<br /><br>5. Somatisation scores using the Children Somatisation Inventory (CSI);<br /><br>6. Sense of Coherence using the 13-item Dutch Sense of Coherence questionnaire for children (SOC-K);<br /><br>7. Compliance and satisfaction TM/HT/SMT;<br /><br>8. Adverse events.