None listed
Conditions
Brief summary
We will assess the effect of Photobiomodulation therapy (PBMt; ‘light therapy’) on nipple pain in breastfeeding women to contribute information for establishing optimal treatment settings. The study will be conducted at The Possums Clinic, Brisbane. Forty-six eligible participants with nipple pain will be recruited for this study and randomised into either intervention Group A (standard gestalt intervention plus light therapy) or Group B (standard gestalt intervention plus sham light therapy). In addition to the review of the gestalt therapy techniques at every appointment (thrice weekly for the duration of the study), light therapy will be administered three times per week and thrice weekly treatment will continue until the participant reports zero pain, or for 4 weeks, whichever occurs sooner. We expect that the use of light therapy will reduce nipple pain earlier than would be expected with standard gestalt therapy alone.
Interventions
The gestalt method of care is a new biomechanical model, with the intention of providing an evidence-based, teachable and replicable approach to latch and positioning/fit and hold intervention. This model is based on findings of the latest ultrasound and vacuum studies, in collaboration with the Hartmann Human Lactation Research Group at The University of Western Australia, and is corroborated by an MRI series in 11 breastfeeding pairs and an ultrasound case series of 5 breastfeeding pairs (unde
The gestalt method of care is a new biomechanical model, with the intention of providing an evidence-based, teachable and replicable approach to latch and positioning/fit and hold intervention. This model is based on findings of the latest ultrasound and vacuum studies, in collaboration with the Hartmann Human Lactation Research Group at The University of Western Australia, and is corroborated by an MRI series in 11 breastfeeding pairs and an ultrasound case series of 5 breastfeeding pairs (under review). The gestalt method of care is reviewed as part of the lactation consultation by the GP trained in the model, and at each appointment immediately prior to the application of the study intervention described below. The intervention is (scientifically) called photobiomodulation (PBM), and in lay terms "light therapy". The study will investigate if light therapy applied 3 times / week (up to 4 weeks in total) has an effect on reducing pain from nipple trauma in post-natal women who wish to breastfeed, and who may need support and education regarding the breastfeeding technique. Light therapy will cease if pain is reported as 0/10 before the end of the planned protocol. The device to be used is the Handy Pulse Laser device. The device emits light at the following wavelengths: - Super pulsed infrared laser diode 905nm wavelength - 4 x Visible Red LEDs 635nm - 4 x Infrared LEDs 875nm - Static Magnetic Induction - Parameters: pulsed 50Hz, 13.5mW, 905nm laser (and 635nm and 875nm LED wavelengths), 4J/cm2, 0.7cm2 spot size, pulse width 100ns, pulse energy 2.5µJ. - Application site: The light therapy device will be held directly over and centered on the affected nipple as close as possible without physical contact. The light therapy intervention is planned to be standardised for all participants, i.e., no individualisation. Duration of light therapy is 5 minutes if only one breast is affected; and 10 minutes if both breasts are affected. All participants will receive the usual Gestalt method of care offered at the study site but the gestalt method itself is not being evaluated. Standard care plus light therapy will be applied individually to consenting participants in a clinic setting by Fellows of the Royal College of General Practitioners who are also trained lactation consultants, and have received training in the safe use of the light therapy device. Participants will be randomised in to 2 groups: one group will receive active treatment and the other will receive the comparator therapy. The location of the intervention is an metropolitan midwifery, gynaecology and obstetrics practice. Treatment adherence will be assessed by monitoring of session attendance.
Sponsors
The Possums Clinic Medical Director, Dr Pamela Douglas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Nipple pain with breastfeeding after baby has latched or pain between feeds • Mother >18years old • Planning to exclusively breastfeed • Spoken English to understand consent process and participate in answering questionnaires (this will be determined during initial history-taking) • Baby taking no more than 180 mls formula daily • Using nipple shields to breastfeed due to pain • Partly putting the baby to the breast and partly using expressed breast milk in a bottle or other device • Not putting baby on breast at all due to pain.
Exclusion criteria
• Breast malignancy, • Light photosensitivity, or • Uncontrolled psychological disorders.
Outcome results
None listed