Investigating the contextual modulation of postoperative gastrointestinal motility: a methodological feasibility study combining a standardized intervention protocol with wireless motility capsule monitoring.
7 affiliations
- 1Clinical Study Core Unit, Study Center Bonn (SZB), University Hospital Bonn, University of Bonn, Bonn, Germany.
- 2Institute for Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, University of Bonn, Bonn, Germany.
- 3Institute of Medical Psychology and Behavioral Immunobiology, Center for Translational Neuro- and Behavioural Sciences, University Hospital Essen, Essen, Germany.
- 4Department of Clinical Neuroscience, Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.
- 5Department of Surgery, University Hospital Bonn, University of Bonn, Bonn, Germany.
- 6Department of Urology and Paediatric Urology, University Hospital Bonn, University of Bonn, Bonn, Germany.
- 7Department of General and Visceral Surgery, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin und Humboldt-Universität zu Berlin, Campus Benjamin Franklin, Berlin, Germany.
Abstract
Background
Objective measurement of placebo effects on gastrointestinal function remains a methodological challenge, as most studies rely on patient-reported outcomes. Wireless motility capsule technology (SmartPill®) offers continuous, objective, in-vivo recording of motility parameters throughout the gastrointestinal tract, potentially providing physiological endpoints for placebo research. This methodological feasibility study, nested within the prospective PIDuSA trial, aimed to evaluate whether SmartPill®-based motility monitoring can be feasibly combined with a standardized contextually-enhanced drug administration protocol in patients following abdominal surgery.Methods
A subgroup of six patients received laxatives (9 administrations) from a senior physician incorporating contextual moderators known to enhance placebo responses. Forty-three control group patients received standard administration by nursing staff (180 administrations). The SmartPill® continuously recorded gastrointestinal motility parameters. Primary outcome was the Motility Index calculated over three 30-min periods: baseline, early effect (30-60 min post-administration), and late effect (240-300 min post-administration). Clinical outcomes included stool passage and peristalsis development within 24 h.Results
The methodological approach proved feasible, although no consistent improvements in motility parameters were observed. The contextual intervention protocol was associated with descriptive trends toward improved clinical indicators like peristalsis on auscultation (77.8% vs. 55.6%) and stool passage (33.3% vs. 31.7%), but physiological parameters remained largely unchanged.Conclusion
This feasibility study demonstrates that combining a standardized contextual intervention protocol with continuous SmartPill®-based gastrointestinal motility monitoring is operationally feasible in the postoperative setting. The approach successfully captured objective physiological data across all administrations, providing a preliminary methodological framework for future adequately powered trials investigating the modulation of gastrointestinal function by therapeutic context interventions. The absence of significant motility changes in this exploratory sample size does not allow conclusions regarding the presence or absence of contextual effects. We provide a detailed protocol description to facilitate replication and inform future study design.
Related
- Investigating the association between osteoarthritis and cardiovascular disease using a standardized cardiovascular health assessment tool in a nationwide health survey
- Investigating the Efficacy of the Proactive Automatised Lifestyle intervention among general hospital patients (ePAL): study protocol of a randomised controlled trial.
- Investigating the effect of theory-based educational intervention on enhancing physical activity and reducing weight among overweight and obese students
- Association between radiotherapy laterality and cardiovascular disease mortality in male breast cancer patients receiving postoperative radiotherapy: a competing risks analysis and standardized mortality ratio assessment using SEER data.
- Microbiota-mediated naringenin release limits postoperative acute gastrointestinal injury by suppressing ferroptosis
BibTeX
@article{coenen2026investigating,
title = {{Investigating the contextual modulation of postoperative gastrointestinal motility: a methodological feasibility study combining a standardized intervention protocol with wireless motility capsule monitoring.}},
author = {Martin Coenen and Manfred Schedlowski and Gunther Hartmann and Jörg C Kalff and Thomas Büttner and Tim O Vilz},
journal = {Frontiers in psychology},
year = {2026},
month = oct,
doi = {10.3389/fpsyg.2026.1913608},
url = {https://europepmc.org/article/MED/42922994},
note = {CC BY},
}
RIS
TY - JOUR
TI - Investigating the contextual modulation of postoperative gastrointestinal motility: a methodological feasibility study combining a standardized intervention protocol with wireless motility capsule monitoring.
AU - Martin Coenen
AU - Manfred Schedlowski
AU - Gunther Hartmann
AU - Jörg C Kalff
AU - Thomas Büttner
AU - Tim O Vilz
PY - 2026
DA - 2026/10/08
JO - Frontiers in psychology
DO - 10.3389/fpsyg.2026.1913608
UR - https://europepmc.org/article/MED/42922994
AB - Background Objective measurement of placebo effects on gastrointestinal function remains a methodological challenge, as most studies rely on patient-reported outcomes. Wireless motility capsule technology (SmartPill®) offers continuous, objective, in-vivo recording of motility parameters throughout the gastrointestinal tract, potentially providing physiological endpoints for placebo research. This methodological feasibility study, nested within the prospective PIDuSA trial, aimed to evaluate whether SmartPill®-based motility monitoring can be feasibly combined with a standardized contextually-enhanced drug administration protocol in patients following abdominal surgery.Methods A subgroup of six patients received laxatives (9 administrations) from a senior physician incorporating contextual moderators known to enhance placebo responses. Forty-three control group patients received standard administration by nursing staff (180 administrations). The SmartPill® continuously recorded gastrointestinal motility parameters. Primary outcome was the Motility Index calculated over three 30-min periods: baseline, early effect (30-60 min post-administration), and late effect (240-300 min post-administration). Clinical outcomes included stool passage and peristalsis development within 24 h.Results The methodological approach proved feasible, although no consistent improvements in motility parameters were observed. The contextual intervention protocol was associated with descriptive trends toward improved clinical indicators like peristalsis on auscultation (77.8% vs. 55.6%) and stool passage (33.3% vs. 31.7%), but physiological parameters remained largely unchanged.Conclusion This feasibility study demonstrates that combining a standardized contextual intervention protocol with continuous SmartPill®-based gastrointestinal motility monitoring is operationally feasible in the postoperative setting. The approach successfully captured objective physiological data across all administrations, providing a preliminary methodological framework for future adequately powered trials investigating the modulation of gastrointestinal function by therapeutic context interventions. The absence of significant motility changes in this exploratory sample size does not allow conclusions regarding the presence or absence of contextual effects. We provide a detailed protocol description to facilitate replication and inform future study design.
SN - 1664-1078
ER -