Nynnamm - Effects of Infant Directed Singing on Breastfeeding Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Proportion of breastfeeding (yes/no) four weeks after the intervention assessed by telephone
研究概览
简要总结
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.
详细描述
In Sweden, there is an extensive restructuring of care in relation to the concept "good quality, local health care" (God och nära vård). Most new mothers are cared for at home in direct connection to birth, which places new demands on primary health care providers. A lack of knowledge and training for professionals will affect new mothers' opportunities to breastfeed to the extent that they wish. Furthermore, breastfeeding rates are decreasing in Sweden. Contributors to this trend could be health care-related factors, downsizing, staff shortages, and a lack of breastfeeding knowledge and supportive interventions. There is a risk for even lower breastfeeding rates when professionals lack supportive interventions for advising mothers. This is hazardous since its known that breastfeeding is an effective way to ensure child health and survival. Breastfeeding also provides significant health benefits for mothers and is a cost-effective way to reduce health care costs.
Purpose and aims The aim of this study is to evaluate 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 specific aim of the study is to:
- investigate whether maternal infant-directed singing during breastfeeding is effective in increasing the breastfeeding rate 4 weeks after the intervention among mothers with breastfeeding difficulties (primary outcome).
- investigate whether maternal infant-directed singing during breastfeeding is effective in decreasing maternal stress and breastfeeding difficulties up to six months postpartum among mothers with breastfeeding difficulties (secondary outcome).
- describe maternal experiences of using infant-directed singing during breastfeeding among mothers who have breastfeeding difficulties (secondary outcome).
- investigate parent-infant moment-to-moment communication to provide a deeper understanding of breastfeeding situations and potential problems in this context (secondary outcome).
- investigate cortisol levels, sodium levels, and the somatic cell count in breast milk and saliva (cortisol only) among the participating mothers (secondary outcome).
Method Design An exploratory multicenter randomized controlled trial with two parallel groups with an allocation ratio of 1:1 is planned. The investigators hypothesize that a combination of standard breastfeeding support and maternal infant-directed singing during breastfeeding will improve the proportion of breastfeeding mothers, including the mother-infant dyad's experience, and decrease stress among mothers who have breastfeeding difficulties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Living outside Region Dalarna, Sweden
- •Living outside Region Uppsala, Sweden
- •Living outside Region Värmland, Sweden
结局指标
主要结局
Proportion of breastfeeding (yes/no) four weeks after the intervention assessed by telephone
时间窗: 4 weeks after health care visit (intervention)
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.
次要结局
- Breastfeeding status assessed by five questions about latch, suction power and pattern, maternal feeling and nipple shape.(Before intervention, 2 and 4 weeks after intervention, 2, 4, 6 months of infant age.)
- Biological samples of breast milk to determine the somatic cell count.(During health care visit (intervention) on day 1)
- Biological samples of breast milk to determine the sodium levels.(During health care visit (intervention) on day 1)
- Biological samples of saliva and hair to determine cortisol levels in the mother and infant.(During health care visit (intervention) on day 1)
- 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 experience of infant directed singing and breastfeeding support they received during the health care visit assessed by a qualitative interviews about four weeks after the intervention.(Four weeks after the intervention)
- Maternal experience of infant directed singing and breastfeeding support they received during the health care visit assessed by yes/no, likert scale and open ended questions in a survey sent home to the mothers about four weeks after the intervention.(Four weeks after the intervention)
- Micro analysis assessed by a qualitative video observation of multi modal interaction activities by the mother and infant (verbal and non-verbal interactions).(During the breastfeeding session at the health care visit (intervention) on day 1)
- 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)
- Proportion of breastfeeding (yes/no) at 2 and 4 weeks after the intervention and at 2, 4, 6 months of infant age.(Two and 4 weeks after intervention, 2, 4, 6 months of infant age.)
研究者
Jenny Ericson
Associated Professor
Dalarna University