Feasibility and Acceptability of Craniosacral Therapy and Respiratory Training in Mothers of Children with Disabilities: Protocol for a Three-Arm Non-Randomized Controlled Pilot and Feasibility Study.

INTRODUCTION

Mothers of children with disabilities may experience substantial and prolonged psychophysical burden, which can negatively affect psychological well-being, health-related quality of life, and physical functioning. This study describes the protocol of a pilot and feasibility study evaluating the feasibility and acceptability of two distinct non-pharmacological interventions-craniosacral therapy (CST) and respiratory training (RT)-in mothers of children with disabilities.

METHODS AND ANALYSIS: This completed, retrospectively registered, three-arm, parallel-group, non-randomized controlled pilot and feasibility study enrolled 32 mothers, allocated by enrolment timing and project logistics to craniosacral therapy (CST; n = 12), respiratory training (RT; n = 10), or no-intervention control (CG; n = 10). The interventions lasted 8 weeks. Feasibility outcomes included recruitment, consent, retention, attendance/adherence, outcome completeness, fidelity indicators, withdrawals, and reported adverse events; acceptability was assessed indirectly because no dedicated acceptability instrument was administered. Clinical outcomes were exploratory. Analyses estimated pre-post change and between-group differences, with confidence intervals reported where supported by the analyses. Recruitment occurred from May to December 2025, follow-up ended on 30 April 2026, and outcome data were analyzed before submission. Ethics approval preceded enrolment (2-XII/2024); registration was retrospective (ANZCTR ACTRN12626000148370; 5 February 2026).

DISCUSSION: This pilot and feasibility study provides a structured framework for evaluating CST and RT in mothers of children with disabilities. The study is intended to inform methodological procedures, outcome selection, and the design of a future adequately powered randomized controlled trial rather than establish the clinical effectiveness or safety of either intervention.