Nynnamm - Effects of Infant Directed Singing on Breastfeeding Difficulties
ConditionBreastfeeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDalarna University
About this trial
Breastfeeding is one of the most effective, health economical interventions to promote health and reduce illness in both mothers and children. However, breastfeeding in Sweden is under threat. An increasing number of newborns will miss out on its benefits because lack of lactation support for mothers with breastfeeding difficulties, which is the main reasons for breastfeeding cessation. About 110,000 mothers breastfeed every year but the prevalence is decreasing. Many mothers are dissatisfied with the support they receive from health care. Maternal infant-directed singing could be an effective, person- and family-centered, cost-effective, self-care intervention to reduce stress and breastfeeding difficulties in new mothers as well as increasing oxytocin, which is an important hormone for lactation and well-being.
This project evaluates the effect of a self-care intervention involving maternal infant-directed singing during breastfeeding on maternal stress, experiences, and breastfeeding rates up to six months postpartum among mothers with breastfeeding difficulties. The mothers are randomized to standard care and infant-directed singing or control with standard care. The primary outcome is the proportion of breastfeeding four weeks after the intervention. 260 mothers will be included in the project, which will be conducted during 2024-2025, and data will be analyzed and presented in 2026. A data management plan will ensure that all research activities are well organized.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mothers who seek support for breastfeeding difficulties.
Mothers who seek support for experiencing a low milk supply.
Mothers who seek support for sore nipples.
Mothers who seek support for breast pain.
Disqualifiers
Living outside Region Dalarna, Sweden
Living outside Region Uppsala, Sweden
Living outside Region Värmland, Sweden
Trial design
Design model
Parallel
Treatments tested in this trial
Infant directed singing
BehavioralIn every known human culture and historical period, infant-directed singing exists as a natural feature of parental care for newborn infants. Infant-directed singing is effective in regulating infant affect and in capturing an infant's attention for a longer period than infant-directed speech. Parental stress significantly decreases when parents are encouraged to use their own voices to soothe their infants with a song or a lullaby of their choice.
Standard care
BehavioralStandard breastfeeding support to mothers with breastfeeding difficulties provided by health care professionals.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Infant directed singingExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of breastfeeding (yes/no) four weeks after the intervention assessed by telephone
The primary outcome is the proportion of breastfeeding (yes/no) mothers 4 weeks after the intervention, and data on the primary outcome will be collected by telephone by a research nurse.
Time frame
4 weeks after health care visit (intervention)Secondary outcomes
1
Maternal stress assessed by galvanic skin response (GSR), area small peaks, which is obtained via three electrodes on the maternal palm.
Mothers' emotional state/ arousal (stress) before, during and after the breastfeeding session, measured with the GSR device.
Time frame
Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit2
Maternal stress assessed by galvanic skin response (GSR) area huge peaks, which is obtained via three electrodes on the maternal palm.
Mothers' emotional state/ arousal (stress) before, during and after the breastfeeding session, measured with the GSR device.
Time frame
Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit3
Maternal stress assessed by galvanic skin response (GSR), peaks per second, which is obtained via three electrodes on the maternal palm.
Mothers' emotional state/ arousal (stress) before, during and after the breastfeeding session, measured with the GSR device.
Time frame
Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit4
Maternal stress assessed by galvanic skin response (GSR), average rise time, which is obtained via three electrodes on the maternal palm.
Mothers' emotional state/ arousal (stress) before, during and after the breastfeeding session, measured with the GSR device.
Time frame
Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visitLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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