Clinical trial NCT05489861: The Effect of Affirmation and Massage on Babies
Official title: The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attachment
Mother-Infant Interaction
Sleep Quality
Keywords: Baby massage
mother-baby attachment
father-baby attachment
affirmation
sleep quality
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Examining the infant's sleep quality of infant massage and affirmation
timeFrame: 1. week
measure: Examining the infant's sleep quality of infant massage and affirmation
timeFrame: 5. week
measure: Effect on maternal attachment
timeFrame: 1. weeks
measure: Effect on maternal attachment
timeFrame: 5. weeks
measure: Effect on paternal attachment
timeFrame: 1. week
measure: Effect on paternal attachment
timeFrame: 5. weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kadikoy
country: Turkey
facility: Nilay Şener Özovalı
state: İstanbul
Study officials:
References: