To determine the (cost)-effectiveness of home-based hypnotherapy by self-exercises added to usual care (UC) of general practitioners (GPs) compared with UC of GPs alone in children with FAP or IBS.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of children with adequate relief of abdominal pain and
discomfort at 12 months.
Secondary outcome
The frequency and intensity of the abdominal pain/discomfort, school absence,
impact on daily functioning, depression and anxiety, pain beliefs, sleep
disturbances, use of healthcare services and cost-effectiveness at 3, 6, and 12
months.
Background summary
Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are the two
major functional abdominal pain disorders in children in which symptoms cannot
be explained by an organic condition. These functional disorders are associated
with a substantial reduced quality of life, school absence, sleep disturbances,
and anxiety and depression. Most children with FAP or IBS are managed in
primary care. Management of FAP or IBS in primary care is challenging, however
in specialist care hypnotherapy by self-exercises is an evidence-based
treatment. Evidence from applying these hypnotherapy self-exercises in primary
care is absent, but this approach may be effective, reduce costs and minimize
time investments for children, parents, physicians and therapists.
Study objective
To determine the (cost)-effectiveness of home-based hypnotherapy by
self-exercises added to usual care (UC) of general practitioners (GPs) compared
with UC of GPs alone in children with FAP or IBS.
Study design
Randomised controlled trial with a total follow-up of 12 months.
Intervention
Home-based hypnotherapy through self-exercises 5 times a week for approximately
15-20 minutes per day during 3 months in addition to UC of the GP. This will be
compared with a control group receiving UC, which is defined as care according
to the Dutch Society of GPs* guideline for abdominal pain in children.
Study burden and risks
Risks of participation are considered negligible. The risks for the
intervention group are minimal as adverse effects are rare and not observed
from previous studies on hypnotherapy by self-exercises. The exercises may be
comparable with day-dreaming or relaxation. Furthermore, all children receive
care as usual according to national treatment guidelines. The burden of the
home-based hypnotherapy intervention has been based upon results from a
previous study and thereby limited to approximately 15-20 minutes a day, five
days per week, during 3 months. This may ultimately prevent the child from a
long course of abdominal symptoms, impairments, referrals to specialists and
extensive diagnostic testing. The burden of administering questionnaires is
expected to be approximately 30 minutes per measurement moment. The study
investigates FAP and IBS in minors, therefore involving parents too.
Oostersingel | ingang 47 | gebouw 50 | 2de verdieping
Groningen 9713EX
NL
Oostersingel | ingang 47 | gebouw 50 | 2de verdieping
Groningen 9713EX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- aged 7 to 18 years
- GP visit concerning chronic gastrointestinal symptoms
- FAP OR IBS according to their GP
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- a concomitant organic gastrointestinal disease
- treatment by paediatrician for abdominal symptoms
- mental retardation
- a history of a psychotic disorder
- hypnotherapy treatment in the past year
- insufficient knowledge of the Dutch language by the child or parents
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73562.042.20 |
| Other | NL8500 (NTR register) |