Nynnamm - Effects of Infant Directed Singing on Breastfeeding Difficulties

NCT06085989 | Not Yet Recruiting

• 1 other identifier: 280958
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breastfeeding

Outcome Measures

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.

  4 weeks after health care visit (intervention)

Secondary Outcomes (13)

• Maternal stress assessed by galvanic skin response (GSR), area small peaks, which is obtained via three electrodes on the maternal palm.

  Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit

• Maternal stress assessed by galvanic skin response (GSR) area huge peaks, which is obtained via three electrodes on the maternal palm.

  Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit

• Maternal stress assessed by galvanic skin response (GSR), peaks per second, which is obtained via three electrodes on the maternal palm.

  Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit

• Maternal stress assessed by galvanic skin response (GSR), average rise time, which is obtained via three electrodes on the maternal palm.

  Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit

• Maternal stress assessed by galvanic skin response (GSR), average peak, which is obtained via three electrodes on the maternal palm.

  Two minutes before, after three minutes breastfeeding and two minutes after the breastfeeding session at the intervention visit

Study Arms (2)

Infant directed singing

EXPERIMENTAL

The intervention group will receive standard breastfeeding support from health care staff combined with maternal infant-directed singing during breastfeeding. The starting point of the singing will be individually assessed and tailored to the dyads and will start approximately a few minutes before breastfeeding starts. An educational video about how to apply infant-directed singing will be shown to all mothers in the intervention group.

Behavioral: Infant directed singing

Standard care

ACTIVE COMPARATOR

Mothers allocated to the control group will be offered standard breastfeeding support from health care staff, and data on secondary outcome measures will be collected during one breastfeeding session.

Behavioral: Standard care

Interventions

Infant directed singing BEHAVIORAL

In 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.

Infant directed singing

Standard care BEHAVIORAL

Standard breastfeeding support to mothers with breastfeeding difficulties provided by health care professionals.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Mothers who seek support for feeling stressed.
• Mothers who seek support for feeling unwell while breastfeeding.
• Mothers who seek support for having an infant who has problems with latching the breast.
• Must understand Swedish or English.
• Must be over 18 years old.

You may not qualify if:

• Living outside Region Dalarna, Sweden
• Living outside Region Uppsala, Sweden
• Living outside Region Värmland, Sweden

Sponsors & Collaborators

• Dalarna University: lead

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jenny Ericson, Docent

  Dalarna University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Ericson, PhD

CONTACT

+46707883532; jeer@du.se

Alexandra Ullsten, PhD

CONTACT

alexandra.ullsten@regionvarmland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: October 17, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share