Transcendental Meditation or Hypnotherapy in children with primary headache.

Transcendental Meditation (TM) or Hypnotherapy (HT) for the Treatment of Children with Primary Headaches: A Multi-Centre, Pragmatic, Randomized Clinical Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28446

Enrollment

141

Registered

2011-06-28

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Primary headache, Migraine, Tension-type headache, Primaire hoofdpijn, spierspanningshoofdpijn

Interventions

Transcendental Meditation: The technique of TM will be taught to the children in a 6-step course program, including personal and group sessions. Subsequently, children will exercise TM at home two t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children attending a paediatrician/ paediatric neurologist; 2. Written informed consent by patients and parents; 3. Children age 9-18 years; 4. Suffering from primary headache (according to ICHD-2 criteria); 5. Headache attack frequency: >2 times per month; 6. Ability to understand and speak the Dutch language; 7. Accessible by phone and internet.

Exclusion criteria

Exclusion criteria: 1. Start of prophylactic medication for headache during the trial; 2. Epilepsy or other serious neurological disease; 3. Previous treatment with hypnotherapy or meditation.

Design outcomes

Primary

Measure	Time frame
1. Mean frequency of primary headache attacks: will be noted in a headache diary (4 weeks); 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

Measure	Time frame
1. Mean headache severity and headache duration, associated symptoms and used pain medication; 2. Quality of life using the 50-item CHQ-PF50 (parent form); 3. Anxiety and depression scores using the Revised Children’s Anxiety and Depression Scale-short version (RCADS-25); 4. Coping with pain using the 37-item Dutch Pain Coping Questionnaire (PCQ); 5. Somatisation scores using the Children Somatisation Inventory (CSI); 6. Sense of Coherence using the 13-item Dutch Sense of Coherence questionnaire for children (SOC-K); 7. Compliance and satisfaction TM/HT/SMT; 8. Adverse events.	—

Measure

Time frame

1. Mean headache severity and headache duration, associated symptoms and used pain medication; 2. Quality of life using the 50-item CHQ-PF50 (parent form); 3. Anxiety and depression scores using the Revised Children’s Anxiety and Depression Scale-short version (RCADS-25); 4. Coping with pain using the 37-item Dutch Pain Coping Questionnaire (PCQ); 5. Somatisation scores using the Children Somatisation Inventory (CSI); 6. Sense of Coherence using the 13-item Dutch Sense of Coherence questionnaire for children (SOC-K); 7. Compliance and satisfaction TM/HT/SMT; 8. Adverse events.

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Contacts

Public ContactM. Jong

Louis Bolk Institute Hoofdstraat 24

m.jong@louisbolk.nl+31 (0)343 523860

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)