Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC.
Prospective, non-randomised, open-label pilot study in children with FC (6–18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set.
Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences.
NCT06836362 and NL-OMON57236.
To investigate the effects of active involvement of family caregivers in adult in-hospital care on patients' readmissions, complications, mortality, length of hospital stay, quality of life, psychological distress and activities of daily living, as well as on the satisfaction of patients, HCPs and family caregivers.
Systematic review.
Ovid Medline, Ovid Embase, EBSCO CINAHL, Cochrane Library (from inception to February 2024).
The PRISMA 2020 statement was followed. Prospective controlled studies focusing on active involvement of family caregivers in adult in-hospital care were included. Two independent teams of authors conducted study selection, quality assessment and data extraction.
Thirteen studies were included, comprising 11 randomised controlled trials. The clinical and methodological heterogeneity precluded a meta-analysis. Six of these studies were performed in stroke patients. Some studies reported statistically significant benefits of active family involvement on readmission rates, hospital LOS, ADL, psychological distress for patients and family members, QoL and satisfaction of family caregivers. However, others did not observe differences in these outcomes. For complication rates, mortality and satisfaction of patients and HCPs, no studies demonstrated significant differences between groups.
Further research is needed to provide a conclusive answer as to whether active family caregiver involvement improves outcomes of adult hospitalised patients.
Despite the inconclusive findings of this review, advocating for active involvement of family caregivers in adult in-hospital care fits the perspective of patient- and family-centred care.
As the care of hospitalised adults is shifting to a more family-centric approach, investigating the effects of an active role of family caregivers in adult in-hospital care is necessary. However, the small number of studies available and heterogeneity between studies included in this review hamper firm conclusions. Further evaluations through well-designed studies are required.