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Mothers' Parenting Satisfaction and Parenting Self-efficacy: An Evaluation of a Infant Calming Method

T

Tampere University Hospital

Status

Completed

Conditions

Parenting Satisfaction
Parenting Self-efficacy

Treatments

Behavioral: The 5 S's infant calming intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04296656
R18188H

Details and patient eligibility

About

The main aim of this study is to investigate how to support families with an excessively crying or fussy infant during the first months of the child. The purpose is to discover how an excessively crying or fussy infant affects the mothers' parenting satisfaction and parenting self-efficacy. Furthermore the purpose is to investigate how a behavioral intervention (The 5 S's) affects the infants' mothers' parenting satisfaction and self-efficacy and to evaluate the effectiveness of the intervention.

Full description

This is a randomized controlled follow-up parallel trial that compares PSE and PS in an intervention and control group. The data was collected during March 1st to May 20th, 2019 from three postpartum wards. The mothers were recruited by midwives on the wards after childbirth. The baseline sample size was 250 mothers, which is based on a conducted power analysis. The sample size calculation was based on previous study, from which the standard deviation (0.81) for change in parental satisfaction was calculated. Baseline data were collected before randomization in the hospital. Follow-up data were collected six to eight weeks postpartum at home.

The instruments to assess the study outcomes were the parenting self-efficacy (PSE) scale developed and validated by Salonen et al. and parenting satisfaction (PS) scale, the evaluation subscale of the questionnaire "What Being the Parent of a New Baby is Like" by Pridham & Chang, 1989.

Data were analyzed with SPSS statistical software for Windows, release 25. Descriptive statistics included frequencies, percentages, means and medians. Total scores for the PSE instrument and WBPL-R evaluation subscale (PS) were calculated by summing the scores for all items and dividing the sum by the number of items. Higher scores indicated better outcomes. Comparisons between groups were made of mother characteristics, PSE and PS. Due to skewed distributions, non-parametric tests were used. Mann-Whitney U tests were used for two group comparisons, and Kruskal Wallis tests were used for three or more group comparisons.

Results have not yet been reported.

Enrollment

250 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Primiparous mothers
  • Multiparous mothers
  • Mothers of healthy infants rooming in (with mother)

Exclusion criteria

  • Mothers with infants who were treated on another ward during data collection
  • Mothers with multiple infants
  • Mothers with inability to understand Finnish

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Intervention group
Active Comparator group
Description:
Mothers in the intervention group were taught the infant calming technique 5 S's, a part of The Happiest Baby (THB) method. THB is based on the theory that infants have an innate "calming reflex" that can soothe infant fussing, excessive crying and prolong sleep. This reflex is triggered by five activities that mimic the sensory milieu of the womb. The 5 S's include swaddling, side position, sound (white noise), swing and suck. The intervention consisted of a 20-minute face-to-face guidance session with the researcher, executed individually in the mother's hospital room. Each mother was given a leaflet to take home that explained the 5 steps in short. Safety issues, such as safest sleep position (supine), allowing hips to flex and how to avoid overheating when swaddled, were addressed. The same researcher executed each guidance session to maintain standardization.
Treatment:
Behavioral: The 5 S's infant calming intervention
Control group
No Intervention group
Description:
Standard care on postpartum ward (breastfeeding and infant care guidance and support in recovering from childbirth and transitioning into parenthood).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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