Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04296656
Other study ID # R18188H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2018
Est. completion date May 31, 2019

Study information

Verified date March 2020
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date May 31, 2019
Est. primary completion date May 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Finland Tampere University Hospital Tampere Pirkanmaa

Sponsors (2)

Lead Sponsor Collaborator
Tampere University Hospital Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parenting satisfaction (PS) The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?". Baseline
Primary Change in Parenting satisfaction (PS) The questionnaire "What Being the Parent of a New Baby is Like" measures parenting satisfaction and has three distinct subscales: evaluation (11 items), centrality (8 items), and life change (6 items). The Evaluation subscale contains 11 items where the mothers responded on a nine-point scale with verbal end anchors, such as 1 = not at all (satisfied) to 9 = completely (satisfied). Higher scores indicate more PS. The evaluation subscale contains items such as "How well do you know your baby?", "How satisfied are you in being a parent of a new baby?" and "How satisfied are you with baby care tasks?". 6-8 weeks postpartum
Primary Parenting Self-Efficacy (PSE) This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes. Baseline
Primary Change in Parenting Self-Efficacy (PSE) This questionnaire measures parenting self efficacy and is domain-specific, and it includes 27 items measuring different infant care skills. These skills are cognitive skills (11 items) such as "I know how to calm a crying baby", affective skills (seven items) such as "I know what my baby enjoys" and behavioural skills (nine items) such as "I'm able to put my baby to sleep". The instrument has a six-point Likert scale 1 = "strongly disagree" to 6 = "strongly agree". Total parenting self-efficacy scores were calculated by adding up the scores of all items and dividing the sum by the number of items. In addition, the score for each subcategory was calculated by adding up the scores of all items in the subcategory and dividing the sum by the number of items. In this instrument, higher scores indicate better outcomes. 6-8 weeks postpartum
See also
  Status Clinical Trial Phase
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Active, not recruiting NCT05180487 - Parenting Young Children Study N/A