Breastfeeding Osteopathic Manual Therapy Study
Research by Southern Cross University
Kirsty Greenwood (PhD Candidate) and her supervisors, Professor Sandra Grace and Dr Roger Engel from the Southern Cross University Faculty of Health, and Dr David Todd from Australian National University, are conducting a study exploring osteopathic care and international-board-certified lactation consultant care for infants having difficulty breastfeeding.
Lactation consultants, midwives and maternal health nurses often refer to osteopaths to help manage breastfeeding difficulty when the baby has difficulty latching and maintaining latch to the breast. This project aims to investigate the effect of adding Osteopathic Manual Therapy (OMT) for musculoskeletal dysfunction to IBCLC for infants with breastfeeding difficulty.
What does participation involve?
If you choose to participate in the study, you will need to book into a pre-screening consultation with Kirsty Greenwood to determine your eligibility to participate. You can make a pre-screening appointment with the research team.
During this pre-screening, you will be asked to sign a pre-screening consent form and consent for a breastfeeding assessment where a practitioner will assess your infant breastfeeding.
Your involvement in the study will be either 3.5 hours over an 8-week period or 6 hours over an 8- week period, depending on which group you are allocated into.
There are no costs to you for participating in this project all treatment is free. If you are suitable for inclusion in the study and consent to participate, you will be randomly assigned into one of two groups.
We cannot predict which group that you will be in.
Group 1: International Board-Certified Lactation Consultation Care
Group 2: Osteopathic Care and International Board-Certified Lactation Consultation Care
Before you start the trial you will have another breastfeeding examination and will be asked to give a detailed medical history, including questions about your pregnancy, birth, feeding and infant developmental history.
You will then be asked to fill in two questionnaires:
1. Breastfeeding Self-Efficacy Score – Short Form (BSES-SF) and
2. Visual analogue scales for pain, noise, and ability to latch and maintain latch
You will be asked to fill in the same questionnaires at week 2 and week 8 of the study.
If you are in Group 1, you will receive two face-to-face sessions with an international board-certified lactation consultant (IBCLC) and two phone consultations.
The first appointment will take 1 hour; the following sessions will take 30 minutes. You must be available to attend both IBCLC appointments and also be available for two follow-up telehealth phone calls.
If you are in Group 2, you will receive two face-to-face sessions with an IBCLC, two phone consultations and up to four sessions with a paediatric osteopath. The first appointment with the osteopath or IBCLC will take 1 hour each; the following sessions will take 30 minutes. You must be available to attend all appointments.
Possible benefits and risks to participants
During this trial, we are using treatment interventions (IBCLC and or OMT). We do not know if these interventions will help with your breastfeeding difficulty or not.
Although the research team prioritises both safety and the ethical treatment of all participants, there are risks associated with any experimental treatment; they include possible physical harm, familial distress, and the risk of disclosure of sensitive personal information.
An independent Human Research Ethics Committee has reviewed and approved our mitigating and management strategies to reduce risks as much as possible in this research.
We minimise risks by involving only experienced IBCLC and Osteopathic practitioners. You and your infant receive standard IBCLC care (independent of group allocation), along with regular check-ups over the 8-week trial period. All osteopathic practitioners undergo advanced clinical training, using low-force, gentle osteopathic techniques. They also have a working with children check. If at any point you become distressed about your breastfeeding, we offer counselling through the Australian Breastfeeding Association.
You will receive a thorough infant feeding assessment and IBCLC support. Group 2 participants receive musculoskeletal assessment and treatment by a paediatric osteopath. Group 1 can opt for osteopathic intervention after the 8-week trial. You may withdraw from the study at any time.
The data collected up to the time of withdrawal will be retained and may be used in the data analysis.
Inquiries
Please do not hesitate to contact one of the Southern Cross University research team if you have any questions about the study.
Dr Kirsty Greenwood e: k.greenwood54@student.scu.edu.au,
Prof. Sandra Grace e: sandra.grace@scu.edu.au or
A/Prof. Roger Engel e: roger.engel@mq.edu.au
Project Ethics Approval ID: 2024/082