‘The effect of hypnotherapy on asthma control in children.’

Background of the study:

Asthma is the most common chronic condition in childhood, characterized by episodic airflow limitation, which can be relieved by different types of inhaled bronchodilator therapy. No asthma treatment currently available provides protection to all patients and a substantial number of asthmatic children will experience symptoms in spite of their therapy. It is therefore clinically important that new venues of therapy will be explored. Hypnotherapy has been reported as a promising therapy within pediatric respiratory medicine. More randomized controlled studies are needed to fully explore the possible benefits of hypnotherapy for asthmatic children. In this study, we want to analyse the protective effect of hypnotherapy on asthma control in children with exercise induced bronchoconstriction (EIB).



Objective of the study:

Primary Objective: • To assess the protective effect of hypnotherapy training on asthma control (measured with the fall in FEV1 after an ECT ) in children with EIB between 8-18 years. Secondary Objectives: • To assess the protective effect of hypnotherapy on EIB as assessed with Forced Oscillation Therapy (FOT). • To assess the effect of hypnotherapy training on subjective daily asthmatic symptoms, using the C-ACT and the PAQLQ.



Study design:

This study is a multicenter randomized controlled trial. The patients will be recruited from two hospitals: MST and St. Antoniuis hospital. The patients from MST will undergo their ECT at the OCON in Hengelo. The patients from the St. Antonius Hospital will undergo their ECT at the Center of Excellence in Amersfoort. The ECT will be performed by a researcher who is blinded (single-blind). The hypnotherapy sessions and the visit to the nurse practitioner will take place in hospital where the patients were recruited.



Study population:

Asthmatic children between 8-18 years with mild to moderate EIB (fall of FEV1 < 40%) as only sign of uncontrolled asthma.



Intervention (if applicable):

The intervention group will receive 2 hypnotherapy sessions and are instructed to perform daily hypnotherapy exercises at home during 4 weeks. In the control group maintenance medication will not be changed.



Primary study parameters/outcome of the study:

The effect of hypnotherapy on asthma control compared to standard care, as measured with the fall in FEV1 during an exercise challenge test (ECT).



Secundary study parameters/outcome of the study (if applicable):

The effect of hypnotherapy on asthma control compared to standard care, as measured with FOT. The effect of hypnotherapy on subjective asthmatic symptoms as measured with the questionnaires C-ACT and PAQLQ.

We expect treatment with hypnotherapy will diminish fall in FEV1 after exercise and improve quality of life.

During their first visit, children will fill out the C-ACT and PAQLQ and demographic data on age, sex and body mass index (BMI) will be noted. Lung function will be assessed with spirometry during a standard ECT (jumping castle or treadmill, depending upon the preference of the child with regard to age) and with FOT. In the next 4 weeks, group 1 will receive standard care as previously described, while group 2 will receive standard care complemented with hypnotherapy.

After 4 weeks, the participants will again fill out the C-ACT, PAQLQ and perform an ECT again.

Hypnotherapie