None listed
Conditions
Brief summary
The purpose of this study is determine which wavelength (red or infrared) LLLT is more effective for the management of nipple trauma. We also aim to determine stakeholder’s acceptability of the use of LLLT as an adjunctive treatment modality for nipple trauma. Current guidelines recommend infants to be exclusively breastfed in the first 6 months of life to optimise their growth and development and minimise their risk of illnesses. Although most women are physiologically capable of breastfeeding, only 37% of infants worldwide are exclusively breastfeed for the first 6 months of life with nipple trauma being the second leading cause of early breastfeeding cessation. Current research supports that warm water compresses, menthol and breastfeeding correction are effective treatments modalities for nipple pain. However, future studies regarding other interventions, including LLLT, are currently limited and require more robust studies to draw firm conclusions. LLLT has been used to accelerate wound healing since its introduction in the 1960s. Although the exact mechanism of LLLT is not entirely understood, it is a phototherapy which has been shown to reduce pain and swelling and promote wound healing through cellular mechanisms. Typically, shorter wavelengths have more superficial penetration, where as longer wavelengths having more deeper penetration. Both red LLLT (660nm) and infrared LLLT (9040nm) have been studied, demonstrating promising effects on reducing nipple pain. However, no study has compared which wavelength is most effective in treating nipple trauma. The current Mater Mothers work guideline is centred around midwife’s and/or lactation consultants correcting latching and breastfeeding positioning. LLLT would be an adjunctive to current standard care provided at the Mater. The results of this study will be utilised to guide the Mater Mothers work place guidelines for nipple trauma and nationwide.
Interventions
This study will be conducted at the Mater Mothers' Private Hospital on the private inpatient maternity wards.
Participants with nipple trauma will be randomly allocated to Group A (standard care + red light therapy) or Group B (standard care + infrared light therapy). Standard care, as per Mater Policy, currently involves midwives and/or lactation consultants assisting with breastfeeding positioning and infant latching correction.
In addition to standard care, Group A and B will receive thre
This study will be conducted at the Mater Mothers' Private Hospital on the private inpatient maternity wards. Participants with nipple trauma will be randomly allocated to Group A (standard care + red light therapy) or Group B (standard care + infrared light therapy). Standard care, as per Mater Policy, currently involves midwives and/or lactation consultants assisting with breastfeeding positioning and infant latching correction. In addition to standard care, Group A and B will receive three sessions of light therapy which will be administered within 24 hours post group allocation. The light therapy treatments will be conducted by a qualified physiotherapist face to face in the study participants inpatient room on the postnatal wards. Both participant and therapist will wear safety glasses during the procedure to mitigate the risk of ocular damage if eye exposure to the LLLT incidentally occurs. A safety sign outside the participants room will be also be used to ensure no one else enters the room whilst performing the procedure. A MID-LITE 6565 laser which contains two diodes will be used for group A with parameters being: continuous; wavelength 660nm; dose 4J/cm2. Three points over the nipple will be treated. The clock face method will be used to describe the treatment application. For the three applications, one diode will be placed directly over the centre of the nipple, with the second diode directing treatment at 12 o'clock, 4 o'clock and then 8 o'clock. Total application time per session will be 10 minutes. A MID-LITE 904 infrared laser which contains three diodes will be used for Group B with settings adapted from Chaves et al., 2012 study as follows: continuous, wavelength 860nm; 50 mW power; dose 4J/cm2. The first application will involve positioning the first diode over the nipple with the other two diodes directed at 12 o'clock. The second application will be placed horizontally 2mm below the nipple on the breast, with the second diode placed directly underneath the nipple. Total application time per session will be 10 minutes.
Sponsors
Mater Misericordiae Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
delivered through HATCH (private obstetrician cohort), nipple trauma, mother >18years old exclusively breastfeeding, infant rooming-in and spoken English to understand consent process, comprehend and participate in answering questionnaires.
Exclusion criteria
breast malignancy, diagnosed chronic illness such as persistent pain or psychological disorders, sensitivities to light
Outcome results
None listed