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Clinical Trials/NCT05489861
NCT05489861
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The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study

Istanbul University - Cerrahpasa (IUC)1 site in 1 country45 target enrollmentAugust 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attachment
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
45
Locations
1
Primary Endpoint
Examining the infant's sleep quality of infant massage and affirmation
Last Updated
3 years ago

Overview

Brief Summary

The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant attachment. The research will be carried out between August and October 2022 by including the parents of the babies in the scope of the study. The Mother-Father and Infant Information Form and the Extended Infant Short Sleep Questionnaire, the Maternal Attachment Scale, and the Father-Infant Attachment Scale will be used to collect the data.

Detailed Description

This study was designed as a randomized controlled experimental study with the aim of examining the effect of affirmation and massage applied by mothers and fathers to their infants on their infants' sleep quality and maternal-paternal attachment. Infants aged 0-6 months will be included in the study. In the study, 15 babies (d=0.80, G=0.80, p=0.05) will be randomly selected for each group, Experimental Group 1: The Group To which the Mother Applies Affirmation and Massage (A), Experimental Group 2: The Group To which the Father Applies Affirmation and Massage (B) and Control Group (C) will be determined as three groups. Some criteria will be considered in infants selected and not selected into groups. Experimental Group 1: Mothers in Group (A) Affirmation and Massage, Experimental Group 2: Fathers in Group (B) Affirmation and Massage, 3 days a week for 15 minutes, will be taught to apply affirmation and massage. Affirmation and massage applications will be shown once in the practice hall of the center as an example for the mother and father to be applied to their baby. Afterwards, affirmation and massage applications will be applied by the mother and father at the baby's home. After 5 weeks, the experimental and control groups will be invited to the center and the results will be compared by measuring with the data collection tools again.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Nilay Şener Özovalı

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Healthy infants
  • Non-pregnant mothers
  • Mothers and fathers who agree to participate in the study
  • Who do not have communication problems
  • Who does not have a chronic and mental disease

Exclusion Criteria

  • Babies with any disease
  • Diagnosed with sleep a disorder

Outcomes

Primary Outcomes

Examining the infant's sleep quality of infant massage and affirmation

Time Frame: 5. week

The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. It will apply to both mothers and fathers. This scale does not have a score. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.

Effect on maternal attachment

Time Frame: 5. weeks

The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment

Effect on paternal attachment

Time Frame: 5. weeks

The paternal-infant attachment scale will be used. At the beginning and end of the research. It will only apply to fathers. It is a 19-item scale. this scale's high point is 90 and the low point is 18. Each item of the scale is scored between one and five points. Higher scores indicate higher attachment.

Study Sites (1)

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