Hypnotherapy for Abdominal Pain in Childhood.

Background:

Chronic abdominal pain due to irritable bowel syndrome (IBS) or functional abdominal pain (FAP) is common
in children, reduces their quality of life, and is associated with increased risk for depression and anxiety. Therapeutic options are limited, but several trials in children have shown that gut-directed hypnotherapy by a therapist or by self-hypnosis exercises on CD at home are effective treatments. No studies have been performed comparing these two treatments. If self-hypnosis exercises at home are comparable in effectiveness, it brings several potential advantages such as substantial savings in costs and reduction of waiting lists for hypnotherapists. A well designed cost-effectiveness study can discover whether self exercises of hypnotherapy could become the first line therapy of choice in the treatment of these patients.



Aim:

To compare the cost-effectiveness of hypnotherapy by therapist versus hypnotherapy by CD-recorded self exercises at home in children with IBS and FAP.



Methods:

260 children, aged between 8-18yrs, with IBS or FAP according to ROME III criteria will be randomized to one of
these treatments: 6 sessions of individual hypnotherapy given by a therapist during three month period or hypnotherapy through self exercises at home for 3 months.

The primary analysis will be the number of patients with > 50% reduction in abdominal pain intensity and frequency at the end of therapy (3 months) and after one year of follow-up. The expected percentage of success at three month in the therapist group is 75%. Based on the results of a study in children with IBS evaluating the effect of self exercises, we anticipate a success rate off 65%. Based on a non-inferiority limit of 50% and a drop-out of less than 10%, 130 patients per group are needed to test the hypothesis with a power of 80%.

Secondary outcomes will be changes in individual pain scores over time, other abdominal symptoms, anxiety and depression, health-related quality of life, health utility, costs, and school absence, measured at 1 year follow-up.



Time schedule:

The project will take 3 years: In the first two years children will be recruited in 6 hospitals and in the last year follow-up will take place and analysis of all results.



Participating centers in the Netherlands:

1. St. Antonius ziekenhuis Nieuwegein;

2. Medisch Centrum Alkmaar;

3. Leids Universitair Centrum;

4. Academisch Ziekenhuis Maastricht;

5. Amphia Ziekenhuis Breda;

6. Academisch Medisch Centrum Amsterdam;

7. Maxima Medisch Centrum Veldhoven;

8. Flevoziekenhuis Almere.

This study may result in optimization of health care for children with irritable bowel syndrome. If this study shows that home-based therapy is comparable in effectiveness with hypnotherapy by a therapist, it could become therapy of choice in the treatment of these patients.

Such a 7-day diary recording will be done before start of therapy, in the fourth week of treatment, the eight week of treatment, the twelfth (last) week of treatment, six months after treatment and twelve months after treatment.

Patients will be randomly allocated using a computerized random-number generato for concealment to individualized hypnotherapy given by a therapist or home-based therapy with hypnosis exercises on CS's.



Individual hypnotherapy will be carried out by one of six participating hypnotherapists and will consist of 6 sessions of 50 minutes over a 3 month period.



Children assigned to self-hypnosis by CD will be visited by a specially trained research nurse. She will explain the exercises on CD and hand them together with an instruction leaflet. The children are asked to do the first exercises on the CD during this visit to check if all instructions are understood. The children will be asked to listen to the exercises at least 5 times per week during 3 months. The research nurse will make phone calls with the children at week 4 and 8 to stimulate treatment compliance.