The Effect of Affirmation and Massage on Babies

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05489861
Collaborator
(none)
45
1
3
10.9
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: M-AM
  • Behavioral: F-AM
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group A The Group to which the Mother Applies Affirmation and Massage

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

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

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

No Intervention: Control Group (C)

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

Outcome Measures

Primary Outcome Measures

  1. Examining the infant's sleep quality of infant massage and affirmation [1. week]

    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.

  2. Examining the infant's sleep quality of infant massage and affirmation [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.

  3. Effect on maternal attachment [1. 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.

  4. Effect on maternal attachment [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

  5. Effect on paternal attachment [1. week]

    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.

  6. Effect on paternal attachment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nilay Şener Özovalı Kadikoy İstanbul Turkey

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilay Şener Özovalı, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05489861
Other Study ID Numbers:
  • IstanbulUC-NilaySener
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nilay Şener Özovalı, Principal Investigator, Istanbul University-Cerrahpasa

Study Results

No Results Posted as of Aug 5, 2022