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

Primary headache has a high prevalence in children. Worldwide, 57-82% of
children and adolescents suffer from recurrent headaches by the age of 15
years. Tension-type headache (TTH) and migraine are the most important primary
headache syndromes in children and adolescents. In the Netherlands half of all
children between 4 and 18 years of age suffer from headache once or more per
month; 5 to 15 % suffer from migraine. Nowadays children suffer more from
primary headache then 30 years ago; the reason for this is unclear. Primary
headache can have a significant impact on children*s quality of life and
emotional state, often continuing into adulthood. It may result in missed
school days, disturbed peer and family relationships and emotional stress.
In children some symptomatic and prophylactic drugs have been proven effective,
such as sumatriptan nasal spray, ibuprofen and acetaminophen and the
prophylactic drug flunarizine. Adverse effects have been described in both
treatments. Other not evidence based pharmacologic treatment options prescribed
are antihypertensives, antidepressants or antiepileptic drugs. For these drugs
also occasional-frequent adverse events are reported such as nausea and
dizziness. Next to drug therapy, psychological and behavioural treatment might
reduce the frequency and severity of headache in children. A recent review by
Verhagen suggests that there is insufficient evidence for preventive medicine,
physiotherapy, manual therapy, EMG-biofeedback and cognitive behavioural
therapy in children with TTH, although results of small studies are promising.
A few non-pharmacological treatments such as relaxation may be effective as
prophylactic treatment for migraine in children as well. Because of the small
number of these studies and the methodological shortcomings, conclusions on
effectiveness have to be drawn with caution. Therefore, there is a need for
further high-quality research to evaluate non-pharmacological treatment options
with minimal or no adverse effects. The further development of effective
interventions is warranted as it can potentially prevent the progression of a
painful and debilitating condition into adulthood.

Psychological stress and weak coping mechanisms may initiate and propagate
physiological pain. Furthermore, chronic daily headache is co-morbid with
adverse life events, anxiety and depressive disorders, other pain syndromes and
sleep disorders. All these conditions contribute to initiating and maintaining
chronic headaches. Mazzone 2006 demonstrated that both TTH and migraine
patients had higher internalizing (such as anxiety and depression) and
externalizing scores (such as aggression and hyperactivity) than controls. In
conclusion, the different findings described above support the concept that a
simple universal aetiology for chronic headaches does not exist. It is likely
that there is a complex interaction of bio-psycho-social factors that generate
the chronic pain.

Because stress seems an important factor in the pathophysiology of headaches,
therapies that are capable of stress reduction, e.g. relaxation techniques,
seem a good treatment option for this group of patients. Therefore, in this
study we aim to determine the effectiveness of two relaxation techniques:
hypnotherapy and transcendental meditation.

Although some symptomatic and prophylactic drugs have shown to be effective in
children with primary headaches, there is a clear need to evaluate the
effectiveness of non-pharmacological treatment options for this condition with
minimal or no side effects. HT has shown to be beneficial in the treatment of
TTH and migraine in adults. Furthermore, TM has shown to decrease stress and
anxiety in adults. Recently, we have demonstrated that HT is a highly effective
and safe treatment option for children with chronic abdominal pain. Taking into
consideration the positive clinical results of HT and TM in adults, the proven
efficacy of HT in the treatment of children with abdominal pain and the lack of
adverse events with HT and TM in children, the possible benefits of HT and TM
in the treatment of children with primary headaches clearly outweigh any
possible risk.

The goal of this pragmatic, randomized controlled study is to determine the
effectiveness of two relaxation techniques, eg. TM or HT added to the treatment
of paediatric primary headaches in comparison to standard medical treatment
(SMT). TM or HT will be offered in addition to SMT.

For clinical studies on chronic pain, it has been recommended to also
investigate other non-pain outcome parameters such as quality of life, coping
strategies, change of behaviour and affective state and other psychological
parameters (Palermo 2010). So besides the headache frequency, severity and
duration also quality of life, anxiety and depression symptoms, coping
strategies, somatisation scores and sense of coherence will be measured. In
addition, information will be collected on the feasibility of implementation of
HT and TM in the every day paediatric clinical practice .

A multi-centre pragmatic, randomized controlled trial with three parallel
groups. 3 measurements over 10-11 months: Baseline, 3 months (after
intervention) and after 9 months

Standard Medical Treatment: According to the hospital guidelines: Attention for
sleep hygiene, diet, symptomatic (pain, antiemetic) and prophylactic
medication, caffeine and stress reduction during a period of 3 months.
Regularly children will be referred to a physiotherapist or psychologist for
relaxation exercises. In line with the TM and hypnotherapy groups, children in
the control group will be offered relaxation exercise sessions with a maximum
of 6 times within the three-month intervention period.

Standard Medical Treatment + 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 times a
day for 10 minutes over a period of 3 months.

Standard Medical Treatment + Hypnotherapy: Children will receive 6 sessions of
HT over a 3 month period given by certified hypnotherapists. It is encouraged
to do hypnosis exercises at home once a day.

It will be carefully documented which advice, medication and other treatments
are provided, as well for the control group, as for the TM and HT groups.

Although some symptomatic and prophylactic drugs have shown to be effective in
children with primary headaches, there is a clear need to evaluate the
effectiveness of non-pharmacological treatment options for this condition with
minimal or no side effects. HT has shown to be beneficial in the treatment of
TTH and migraine in adults. Furthermore, TM has shown to decrease stress and
anxiety in adults. Recently, we have demonstrated that HT is a highly effective
and safe treatment option for children with chronic abdominal pain . Taking
into consideration the positive clinical results of HT and TM in adults, the
proven efficacy of HT in the treatment of children with abdominal pain and the
lack of adverse events with HT and TM in children, the possible benefits of HT
and TM in the treatment of children with primary headaches clearly outweigh any
possible risk.

Burden: Over 10-11 months children and parents have to fill in a headache diary
and online questionnaires (3 times). The two intervention groups will follow a
relative intense therapeutic/ training program. Therapeutic benefits could be
reached from the specific interventions, by providing children a useful tool in
coping their symptoms, probably lasting into adulthood, possibly enhance their
quality of life. This pragmatic trial aims for better decision making in daily
practice.