EXPRESS: EXpressing in PREmaturity - Simple interventionS
Research type
Research Study
Full title
Does a guided relaxation audio track increase yield of expressed milk in mothers of very preterm infants? A randomised controlled trial and nested exploratory work
IRAS ID
291449
Contact name
Ilana Levene
Contact email
Sponsor organisation
University of Oxford/Clinical Trials and Research Governance
ISRCTN Number
ISRCTN16356650
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Does listening to a relaxation and visualisation audio track increase yield of expressed milk and breastfeeding duration in mothers of babies born very early?
Babies who are born early (prematurely) are more likely to have serious health problems, which can affect them for the rest of their lives. Being born early is also the most common cause of death for newborns in the UK. Giving breastmilk to premature babies prevents serious gut illnesses, infections and eye problems, and builds babies’ brains for their long-term development. However it can be hard for mothers who give birth early to express enough breastmilk for their baby.
This is a trial for women who have given birth when they were less than 7 months pregnant. Half of the mothers will be randomly allocated to listen to a guided relaxation and visualisation soundtrack while expressing milk, on top of normal care, and half the mothers to normal care alone. The soundtrack will talk the mother through relaxing their muscles, deep breathing, picturing their baby and imagining their milk flowing. We want to see if listening to the soundtrack increases the amount of milk mothers can express in the first three weeks after birth. We want to see if the soundtrack will help more mothers to exclusively breastfeed for up to four months after the baby’s due date. We will also look at whether mothers listening to the soundtrack feel less anxious or distressed and other aspects of how they express milk.
The study will take place in the neonatal units of two NHS Trusts in England and is funded by the National Institute of Health Research. It will recruit mothers over a period of 19 months.
Lay summary of study results:
Babies who are born very early (at less than seven months of pregnancy) can’t drink milk directly from the breast or a bottle. Because breastmilk is the best milk for babies born very early, parents are asked to ‘express’ milk from the breasts to give to their babies down a tube into their tummies.Many families find that expressing milk for their premature baby can be challenging. The aim of the trial was to find out if listening to a relaxing recording while expressing milk increased the amount people could express and made them feel less anxious or distressed.
The EXPRESS trial included 132 people who gave birth between 23 and 31 weeks of pregnancy (five to seven months). We gave half the group a relaxing recording to listen to while expressing milk (this was random, like the throw of a dice).
We asked people to tell us about each time they expressed milk on day 4, 14 and 21 after birth and answer some questions. We sent text messages later on to find out how people were feeding their babies.
If you want to download and share the relaxing recording you can find it here: https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.npeu.ox.ac.uk%2Fexpress%2Fdownload-relaxation&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cd6495691b45d46c2ef5808dc00927d62%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638385876397373899%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=GkMtMjhSKZ9Cr5YnnMPUw5Gq475IV80QehYAtKrlmDw%3D&reserved=0
The people who had the relaxing recording expressed on average 74 grams more milk each day than the people who did not. This is roughly the same as 74ml (two and a half ounces).
We can’t say if this difference is the result of chance or if it is because of the relaxing recording (as the difference is not ‘statistically significant’). To be confident that a difference of 74g was because of the recording, we would have needed about 300 people in the trial.
There was no difference between the two groups (the people with the recording and the people without the recording) in how many babies were being fed breastmilk later on (near the due date and four months after the due date).
There was no evidence that the recording made people less anxious or distressed. The two groups had the same average scores on the questionnaire when asked about their anxiety. Three weeks after birth, about half the people in the trial had a level of anxiety that could be called ‘clinical anxiety’.
The two groups had the same average scores on the questionnaire when asked about post-traumatic stress. Three weeks after birth, about one in five of the people in the trial had a level of distress that could be called ‘post-traumatic stress’.
There was no difference in the number of times people expressed, how long they expressed or how long they had skin to skin contact with their baby.
Almost everyone said they had listened to the recording at least once (98%). People said that they listened to the recording three times each day on average.
The people who said that they listened three or more times each day expressed 246g (roughly 246ml) more milk on average than those who said that they listened less than three times each day.
Six out of ten people in the relaxing recording group also used another form of relaxation. One in four people in the group without the recording used another form of relaxation.
Three out of five people liked the recording. Three out of four found it relaxing. About one in ten people disliked the recording and/or said it made them feel less relaxed. The rest of the people were neutral (they didn’t have positive or negative feelings).
A third of people left comments about the recording. The most common positive comments were that people felt relaxed or calmer. The most common negative comments were that listening to the same recording frequently was boring. Several people said they would prefer relaxing music instead of someone talking.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
21/LO/0279
Date of REC Opinion
8 Jun 2021
REC opinion
Further Information Favourable Opinion