Does listening to a guided relaxation recording increase the amount of breastmilk that mothers can express when their babies are born very early?

Does a guided relaxation audio track increase yield of expressed milk in mothers of very preterm infants? EXpressing in PREmaturity - Simple interventionS (EXPRESS): A randomised controlled trial and nested exploratory work

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16356650

Enrollment

132

Registered

2021-04-19

Start date

2021-08-02

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insufficient volume of expressed milk and breastfeeding duration in mothers of very premature infants Pregnancy and Childbirth Unspecified disorders of lactation

Interventions

Once the participant has given informed consent (which can only happen after birth), they will be trained on how to use a pocket accurate scale to weigh their expressed milk and their competence asses

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Mother of 1 or 2 live infants who are: 1.1. Born between 23+0 and 31+6 weeks gestation 1.2. Inpatient on a recruiting neonatal unit at the time of consent 1.3. Aged <4 days of age at the time of enrolment 2. Willing and able to give informed consent for participation in the study 3. Aged =18 years 4. Intends to express milk for =14 days 5. Access to a device that will play an MP3 file

Exclusion criteria

Exclusion criteria: 1. No dating scan antenatally 2. Triplet or higher-order pregnancy with >2 live-born infants

Design outcomes

Primary

Measure	Time frame
Expressed milk volume measured using by weighing the output each time the participant expresses milk in a 24 h period at 4, 14, and 21 days	—

Secondary

Measure	Time frame
1. Proportion of participants expressing =750 g milk in 24 h (the target set by UNICEF Baby Friendly Initiative UK) measured by weighing the output each time the participant expresses milk in a 24 h period at 4, 14, and 21 days 2. Expressing efficiency measured by calculating the average weight of milk expressed per min from each participant weighing their output in a 24 h period, and reporting the length of time they spent expressing, at day 21 3. Anxiety measured using the Spielberger State Trait Anxiety Index, 6 question format (STAI-6) at 21 days 4. Stress reaction score measured using the Post-traumatic stress Check List for DSM-5 (PCL-5) at 21 days 5. Proportion exclusive human milk feeding measured by maternal report at 36 weeks post-menstrual age and 18 weeks after the estimated date of delivery (4 months corrected age) 6. Proportion with any human milk feeding measured by maternal report at 36 weeks post-menstrual age	—

Measure

Time frame

1. Proportion of participants expressing =750 g milk in 24 h (the target set by UNICEF Baby Friendly Initiative UK) measured by weighing the output each time the participant expresses milk in a 24 h period at 4, 14, and 21 days 2. Expressing efficiency measured by calculating the average weight of milk expressed per min from each participant weighing their output in a 24 h period, and reporting the length of time they spent expressing, at day 21 3. Anxiety measured using the Spielberger State Trait Anxiety Index, 6 question format (STAI-6) at 21 days 4. Stress reaction score measured using the Post-traumatic stress Check List for DSM-5 (PCL-5) at 21 days 5. Proportion exclusive human milk feeding measured by maternal report at 36 weeks post-menstrual age and 18 weeks after the estimated date of delivery (4 months corrected age) 6. Proportion with any human milk feeding measured by maternal report at 36 weeks post-menstrual age

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026