NTR3414.
Methods | Study design: RCT Setting: the Netherlands |
Participants | 80 participants > 11 years old |
Interventions | IG: 6 sessions of gut‐directed hypnotherapy CG: 6 sessions of standard medical treatment with supportive therapy |
Outcomes | Starting date: 1 March 2012 Estimated completion date: 1 September 2013 Outcomes: Primary: the number of participants with > 50% reduction in IBS‐SSS pain score Secondary: the effects of therapy on total IBS‐SSS score, adequate relief, HRQoL, IBD disease activity, health utility index, depression, anxiety, somatisation, abdominal pain‐related cognitions, absence of school or work, use of healthcare resources and additional costs, use of IBD medication, colonic sensitivity to distension, faecal protease activity and microbiota and the ability of participant's faecal supernatant to induce colonic hypersensitivity to distension in rats by colonic infusion |
Notes | Funding: ZonMw, The Netherlands Organisation for Health Research and Development Contact: d.r.hoekman@amsterdamumc.nl The authors are in the process of publishing data from this trial, with publication expected in 2020. Unfortunately, they were unable to provide any reports prior to publication. We could not determine whether this study meets our inclusion criteria. |