The Effect of Affirmation and Massage on Babies

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489861
• Other study ID #: IstanbulUC-NilaySener
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 30, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Attachment
• Mother-Infant Interaction
• Sleep Quality

Intervention

Behavioral:
• M-AM
To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.
• F-AM
To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.

Locations

Country	Name	City	State
Turkey	Nilay Sener Özovali	Kadikoy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examining the infant's sleep quality of infant massage and affirmation	The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. The survey has no minimum and maximum points. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.	1. week
Primary	Examining the infant's sleep quality of infant massage and affirmation	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.	5. week
Primary	Effect on maternal attachment	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.	1. weeks
Primary	Effect on maternal attachment	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	5. weeks
Primary	Effect on paternal attachment	The paternal-infant attachment scale will be used. At the beginning and end of the research. Higher scores indicate higher attachment. It will only apply to fathers. It is a 19-item scale. Each item of the scale is scored between one and five points. this scale's high point is 90 and the low point is 18. Higher scores indicate higher attachment.	1. week
Primary	Effect on paternal attachment	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.	5. weeks