Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000776808
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
21/06/2021
Date last updated
7/07/2023
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of Light Therapy for nipple pain in breastfeeding women
Scientific title
A study of Light Therapy for nipple pain in women planning to Exclusively breastfeed and who also receive the Gestalt method of latch and positioning intervention (LiTE-G)
Secondary ID [1] 303425 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LiTE-G
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nipple pain 320722 0
Condition category
Condition code
Reproductive Health and Childbirth 318566 318566 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 319800 0
Treatment: Devices
Comparator / control treatment
There will be two groups in to which consenting participants will be randomly assigned. Both groups will receive the standard gestalt method of care. Standard care for the purposes of this study includes observation, education and guidance by the GP lactation consultant who has undertaken specialised training in infant feeding as part of a suite of evidence-based programs known as Neuroprotective Developmental Care (NDC), The gestalt method includes evidence-based factors of infant latch and positioning, and fit and hold by the infant to the breast of the mother. The appropriate and biomechanically sound principles and technique will be checked at each appointment to ensure that the method is being learned and applied appropriately.

One group will receive active light therapy, and the second group will receive a sham treatment in addition to the gestalt method.
Sham light therapy will be applied using an identical device and procedure as for the active treatment group but the device will be de-activated (i.e., the device will look and sound like an active device but it will not emit any light). All participants will be informed that the study is comparing light with sham (placebo) light therapy.
Control group
Placebo

Outcomes
Primary outcome [1] 326606 0
Numeric pain rating scale (0-10)
Timepoint [1] 326606 0
At entry to study, prior to each light therapy treatment, and the end of study protocol (primary time point). Whilst waiting in the reception area at each appointment, study participants will be asked to score on a scale (0-10) and in writing, the greatest amount of pain they have experienced on breastfeeding since the last treatment. This score will be retained separately to other clinical measures so that the clinician applying the light treatment is blinded to the participant's response.
Secondary outcome [1] 392099 0
Tissue healing will be recorded by the trained clinicians using clinical descriptors, that is:
• Erythematous
o Mild = slightly pink
o Moderate = more pink than one would expect as normal
o Severe = red or pink
• Peeling
• Swollen
• Fissure (= cracks)
• Erosion (= ulcers)
• Blisters (= raised epithelium covering fluid, either clear, yellow, brown or red)
• Bruising (= tissue haemorrhage)
• Scab
• Exudate (estimated to be)
o Infective
o Non-infective
• Slough
And location of damage
Timepoint [1] 392099 0
Compared by clinical observation between entry to study, at each appointment prior to light therapy, and end of study protocol
Secondary outcome [2] 394087 0
Baby behaviour during breastfeed will be assessed through observation and based on whether infant is:
o Relaxed during breastfeed
o Signalling positional instability during breastfeed
Timepoint [2] 394087 0
Compared by clinical observation, at entry to study, at each appointment prior to light therapy, and at exit from study
Secondary outcome [3] 394088 0
Numeric pain rating scale when baby comes on to the breast at each appointment, and prior to light therapy.
Timepoint [3] 394088 0
At entry to study, at each appointment during the gestalt intervention, and at exit from the study
Secondary outcome [4] 394089 0
Mother's behaviour during breast feeding, observed during clinic appointments by GP/lactation consultant when applying gestalt intervention. Observations include:
- the style of fit and hold used by the mother
- position of mother during feeding
- signs that predispose to breast tissue drag in the infant
That is:
o Lips visible
o Abdo and chest rolled away from the mother
o Asymmetrical face-breast bury
o From mother’s view looking down
o Lateral view
o Baby’s forehead against mother’s upper arm
o Spinal misalignment
o Lumbar hyperextension
o Cervical rotation
o Nose buries into breast with blocked air flow
o Baby’s hands between baby’s body and mother’s body
o Baby’s lower hand and arm not wrapped around mother’s breast and side of her body
- Nipple shape after breastfeeding
Timepoint [4] 394089 0
At entry to study, at each appointment when GP/lactation consultant applying gestalt intervention, and at exit from study
Secondary outcome [5] 396396 0
Numeric pain rating scale during gestalt feeding at time of each appointment, and prior to light therapy.
Timepoint [5] 396396 0
At entry to study, prior to each light therapy treatment, and the end of study protocol ,

Eligibility
Key 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.
Minimum age
19 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Breast malignancy,
• Light photosensitivity, or
• Uncontrolled psychological disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomly allocated by an independent statistician to Group A or Group B
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computed block randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the primary outcome in this study is both continuous and measured longitudinally, we employed the sample size calculation suggested by Diggle et al., 2002. Assuming a significance level of 0.05, 80% power, a moderately strong within-subject correlation (rho=0.6), a within-standard deviation of 2.1 (based on a study by Coca et al., 2016), between 6 and 12 time points and an anticipated drop-out rate of 15%, 46 patient participants would be required to detect a 2 point difference in pain levels.
Other data regarding participant progress during the study will be recorded on the data instrument designed for the study. Such data includes the position of the baby whilst feeding, and a description of any damage (such as inflammation or bruising) to the affected nipple/s. This data will be reported descriptively as means (SD) or percentages.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307845 0
Charities/Societies/Foundations
Name [1] 307845 0
Possums and Co (Medical Director: Dr Pamela Douglas)
Country [1] 307845 0
Australia
Primary sponsor type
Individual
Name
The Possums Clinic Medical Director, Dr Pamela Douglas
Address
The Possums Clinic at Kindred, 124 Wellington Road, East Brisbane Queensland 4169
Country
Australia
Secondary sponsor category [1] 308553 0
Individual
Name [1] 308553 0
A/Prof Liisa Laakso
Address [1] 308553 0
Mater Research Institute
Level 2 Aubigny Place,
Raymond Terrace
South Brisbane, Qld 4101
Country [1] 308553 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307843 0
Mater Misericordiae Limited Human Research Ethics Committee
Ethics committee address [1] 307843 0
Ethics committee country [1] 307843 0
Australia
Date submitted for ethics approval [1] 307843 0
01/02/2021
Approval date [1] 307843 0
19/04/2021
Ethics approval number [1] 307843 0
HREC/MML/73165 (V5)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108702 0
A/Prof Pamela Douglas
Address 108702 0
The Possums Clinic at Kindred, 124 Wellington Road, East Brisbane QLD 4169
Country 108702 0
Australia
Phone 108702 0
+61 07 3188 7915
Fax 108702 0
Email 108702 0
[email protected]
Contact person for public queries
Name 108703 0
Pamela Douglas
Address 108703 0
The Possums Clinic at Kindred, 124 Wellington Road, East Brisbane QLD 4169
Country 108703 0
Australia
Phone 108703 0
+61 07 3188 7915
Fax 108703 0
Email 108703 0
[email protected]
Contact person for scientific queries
Name 108704 0
Pamela Douglas
Address 108704 0
The Possums Clinic at Kindred, 124 Wellington Road, East Brisbane QLD 4169
Country 108704 0
Australia
Phone 108704 0
+61 07 3188 7915
Fax 108704 0
Email 108704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have collaborators with whom to share data at this time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.