Study Comparing Pelvic Floor Muscle Training and Cryotherapy Versus Usual Care for Pain Relief in First-Time Mothers After Perineal Injury

What this Trial Is About

Researchers are evaluating the effectiveness and cost-effectiveness of a physiotherapy protocol combining pelvic floor muscle training PFMT and cryotherapy to relieve pain in first-time mothers who experienced significant perineal trauma during vaginal delivery. This hybrid type 1 randomized controlled trial includes 82 primiparous women with perineal lacerations grade 2 or higher or episiotomy, recruited from a hospital in Ribeiro Preto. The study also assesses quality of life, pelvic floor function, genital self-image, and implementation outcomes over six months. Participants are randomly assigned to one of two groups. The Control Group receives usual maternity care, including suturing of the injury and pain medication. The Intervention Group receives the usual care plus a physiotherapy protocol starting immediately postpartum one in-person session during hospitalization with cryotherapy and pelvic floor muscle contraction guidance, followed by 12 weekly remote pelvic floor muscle training sessions and home cryotherapy as needed for up to three months. Throughout the study, assessments occur at 11 time points up to six months after delivery, including pain intensity ratings using an 11-point scale, pelvic floor dysfunction questionnaires, pelvic floor muscle evaluation with ultrasound and palpation, physical activity and functionality measures, quality of life surveys, medication use, genital self-image, and gender-based violence screening. Health professionals, including physiotherapists and doctors, conduct these evaluations, with blinded review of ultrasound images. An economic evaluation also examines costs and benefits from a societal perspective over six months.

Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma