The Effect of Affirmation and Massage on Babies

NCT05489861 | Unknown

• 1 other identifier: IstanbulUC-NilaySener
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Attachment; Mother-Infant Interaction; Sleep Quality

Keywords

Baby massage; mother-baby attachment; father-baby attachment; affirmation; sleep quality

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Experimental group A The Group to which the Mother Applies Affirmation and Massage

EXPERIMENTAL

15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught. Affirmation and massage practices will be shown once in the practice hall of the center as an example for the mother to apply to their baby. Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home. Parents will be informed about the importance of having the same characteristics of the practice room for each application. In addition, the massage video material will be given to the mother with an affirmation note as a reminder.

Behavioral: M-AM

Experimental group B The Group to which the Father Applies Affirmation and Massage

EXPERIMENTAL

15 minutes of affirmation and massage practices, 3 days a week for 5 weeks, will be taught. Affirmation and massage practices will be shown once in the practice hall of the center as an example for the father to apply to their baby. Afterward, affirmation and massage applications will be applied by the mother and father at the baby's home. Parents will be informed about the importance of having the same characteristics of the practice room for each application. In addition, the massage video material will be given to the father with an affirmation note as a reminder.

Behavioral: F-AM

Control Group (C)

NO INTERVENTION

Parents will be asked to continue the implementation of routine sleeping techniques without being taught any practices.

Interventions

M-AM BEHAVIORAL

To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.

Experimental group A The Group to which the Mother Applies Affirmation and Massage

F-AM BEHAVIORAL

To examine the effects of affirmation and infant massage taught to their parents on their infants' sleep quality and parent-infant attachment.

Experimental group B The Group to which the Father Applies Affirmation and Massage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Babies with any disease
• Diagnosed with sleep a disorder

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Nilay Şener Özovalı

Kadıköy, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 5, 2022
• Study Start: August 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: June 30, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)