Hypnotherapy Through Self-exercises in Children With Functional Abdominal Pain in Primary Care

Recruitment

This study will be performed within the network of GPs connected to the Department of General Practice of the UMCG (Academisch Huisarts Ontwikkel Netwerk, AHON).

Children and/or parents visiting the GP with chronic gastrointestinal symptoms (at least 4 days per month during the past 2 months), who had none of the exclusion criteria, will be approached by their general practitioner (GP), either during consultation or following monthly retrospective search of medical records. The GP fills out the study response form including the in- and exclusion criteria and the contact details of the child and/or parents. If the child seems eligible, the child and/or parents will receive the patient information letter. If the child and/or parents are interested in study participation and provide permission, the GP will send the response form to the research team.

To further improve patient recruitment, since August 2022 children and parents are informed through schools, (social) media and the study website. Information includes background on functional abdominal pain (FAP) and irritable bowel syndrome (IBS), hypnotherapy, the current study, and contact information of the research group. The researchers will contact children and/or parents who apply for participation by telephone. The researcher will answer questions and check eligibility criteria. If the child wishes to participate, the researcher sends the PIF and informed consent (IC) forms via a REDCap link to their e-mail address. In the same e-mail, the researcher informs how their GP can find information and the digital response form on the study website. The GP will check the in- and exclusion criteria prior to participation and directly submits the form to the researchers on the study website.

The researcher/research assistant will approach the eligible children and/or parents by telephone within one week after receiving their response form. During the call the researcher/research assistant fills out the Rome IV criteria questionnaire and checks whether the child and/or parents are motivated and willing to participate. Questions by the child and/or parents will be answered. If the child is willing to participate, the researcher/research assistant will inform the child and/or parents, and send the IC forms via a REDCap link to their e-mail address to those who were included directly during consultation. If preferred, the second contact moment may also be face-to-face in the GP's practice instead. A follow-up visit at the GP 4 weeks after inclusion should also be scheduled. If the child does not want to be randomised, the child and/or parents are asked whether they are willing to participate in a cohort. Here, children with chronic abdominal pain and their parents will not participate in the RCT, but they will fill out primary and secondary parameters like in the RCT at baseline and during follow-up via the online system REDCap. If they are willing to participate in the cohort, they will also receive IC forms to be signed via REDCap. The research team will continuously monitor the return of the IC forms, and will call the child and/or parents if they do not return the forms. If child and/or parent(s) prefer written information and IC, the patient information package including a return envelope can be sent by regular post.