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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38283

Enrollment

141

Registered

2011-09-14

Start date

2012-04-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine Tension-type headache

Interventions

Standard Medical Treatment: According to the hospital guidelines: Attention for sleep hygiene, diet, symptomatic (pain, antiemetic) and prophylactic medication, caffeine and stress reduction during

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)