Clinical Trials Directory

Trials / Completed

CompletedNCT04296656

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Tampere University Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALThe 5 S's infant calming intervention5 simple steps to calm a fussy or crying infant. Steps include swaddling, side position, sound (white noise), swing and suck.

Timeline

Start date
2018-12-03
Primary completion
2019-05-20
Completion
2019-05-31
First posted
2020-03-05
Last updated
2020-03-09

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT04296656. Inclusion in this directory is not an endorsement.