None listed
Conditions
Brief summary
The study aims to evaluate the effects of two eight-week preventive interventions—craniosacral therapy and breathing training—on the physical and mental well-being of mothers raising children with congenital disabilities. The research will assess changes in muscle-fascia tension, pain intensity, respiratory function, cortisol levels, mood, and quality of life before and after the interventions. It is hypothesised that both programs will reduce stress and musculoskeletal discomfort while improving overall quality of life and psychosocial functioning.
Interventions
Arm 1 – Craniosacral Therapy (CST): Participants in this group (n=50) will receive individual craniosacral therapy sessions performed once weekly for 8 consecutive weeks by the same certified physiotherapist (Dr. Aneta Gutowska). Each session will last approximately 60 minutes. The therapy involves gentle touch (approx. 5 g pressure, “butterfly touch”) applied to specific areas of the body: feet, sacrum, lumbar spine, diaphragm, thoracic inlet, occipital base, occiput, temporal, frontal, and sphenoid bones. No mobilization or manipulation techniques will be used. Sessions will be conducted individually (1 therapist / 1 participant) in a quiet physiotherapy room equipped with a couch; participants will remain clothed and covered with a blanket. The same intervention protocol will be applied to all participants. Participants will be informed that mild sensations of warmth, cold, or emotional reactions may occur. They will be advised to increase water intake after therapy and to contact the therapist if any symptoms persist beyond 72 hours. Contraindications: active bleeding, meningitis, head trauma, fever, cerebrospinal fluid leakage, intoxication, intracranial bleeding, thrombosis, pregnancy, severe psychiatric disorders, uncontrolled hypertension, or epidural anesthesia within 6 weeks. Adherence will be monitored through an attendance/session log completed by the treating physiotherapist at each weekly visit (date, duration, participant ID). Intervention fidelity will be ensured by having one certified physiotherapist deliver all sessions and by applying a standardized CST protocol to every participant. Any protocol deviations (e.g., shortened session, missed session, adverse reactions) will be recorded in the session log. Arm 2 – Breathing Exercises (BE): Participants in this group (n=50) will complete an 8-week respiratory training program based on American Thoracic Society / European Respiratory Society (ATS/ERS) recommendations for pulmonary rehabilitation. The program includes inspiratory muscle training (PowerBreathe Plus device) following Hill et al. protocol: 2 sets of 30 breaths daily, with individually adjusted load and progressive intensity. Participants will be trained before starting and will continue the program independently at home. In addition, participants will perform controlled breathing exercises aimed at normalizing the breathing pattern: nasal inhalation, 1–2 s breath hold, and slow nasal exhalation, with inspiration:exhalation ratio 1:2. Breathing can be practiced in sitting or quadruped positions, twice daily (morning and evening), 5–10 repetitions per session. Each exercise lasts about 5–10 minutes. Possible side effects: dizziness, tingling, muscle tremor, visual disturbances, or headache (due to hyperventilation); hypotension upon standing; cardiac rhythm disturbances. Participants will be instructed to breathe slowly, avoid forceful inhalation, change posture gradually, and stop exercises if discomfort occurs. Contraindications: respiratory failure, recent pulmonary hemorrhage, active cancer. Participants will receive standardized pre-intervention training (demonstration + written instructions) before starting home practice. As no daily breathing diary will be used, adherence will be monitored by structured self-report at follow-up contacts/assessments (participants will report the number of days/sessions completed and reasons for missed sessions). Training parameters for inspiratory muscle training (e.g., initial load setting and planned progression) will be documented at instruction and reviewed at follow-up. Participants will be contacted weekly (phone/SMS) to reinforce adherence and to record any problems or adverse events. Participants will also be informed that they may contact the study lead at any time in case of questions or concerns. Allocation (non-randomised): This is a non-randomised study. Group allocation will be determined pragmatically based on participant availability/scheduling constraints and feasibility (e.g., the ability to attend sessions at the required times). Allocation will occur after baseline assessment. No random sequence generation or allocation concealment will be used.
Sponsors
Study design
Eligibility
Inclusion criteria
• Women aged 25 years or older and 44 years or younger • Raising one child with a congenital disability (official disability certificate for at least two years) • Generally good health status • Written informed consent to participate in the study • Written declaration confirming absence of exclusion criteria • Perceived stress level corresponding to a WHO-5 Well-Being Index score equal to 24 points • Musculoskeletal pain rated between 1 and 4 points on the Visual Analogue Scale (VAS 0–10), and/or presence of tension-related movement limitations detected during functional assessment
Exclusion criteria
Pregnancy or postpartum period (if less than 12 months after last delivery) • History of cancer with a disease-free period less than five years • Recent severe injury (e.g. head, chest, or abdominal trauma within the past three months) • Acute illness or inflammation within the last month • Chronic diseases causing organ failure or limiting physical function (e.g. respiratory failure) • Malnutrition (BMI less than or equal to 18.5) • Obesity (BMI greater than or equal to 35) – jesli o to chodzilo, doprecyzuj • Uncontrolled hypertension (systolic blood pressure greater than or equal to 150 mmHg or diastolic blood pressure greater than or equal to 100 mmHg) • History of myocarditis, stroke, transient ischemic attack, or cardiac pacemaker implantation • Active intracranial bleeding, aneurysm, or thrombosis • History of pulmonary embolism or recent pulmonary hemorrhage • Uncontrolled epilepsy • Frequent dizziness, syncope, or falls within the past month • Psychiatric disorders or addiction to alcohol or psychoactive substances • Communication difficulties (e.g. speech disorder, lack of Polish language comprehension) • Congenital defects or disabilities affecting physical or mental function • Fever or acute infection • Musculoskeletal pain intensity greater than or equal to 5 points on the Visual Analogue Scale (VAS 0–10) • Any health condition that, in the investigator’s opinion, poses a safety risk during the intervention • Mother raising more than one child with a disability • Epidural anesthesia within the last six weeks • Skin lesions at the sites of MyotonPRO measurement