The Effect of Affirmation and Massage on Babies

NCT ID: NCT05489861

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Attachment Mother-Infant Interaction Sleep Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

M-AM

Intervention Type 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

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.

Group Type EXPERIMENTAL

F-AM

Intervention Type BEHAVIORAL

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

Control Group (C)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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M-AM

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Nilay Şener Özovalı

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nilay Şener Özovalı

Kadıköy, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IstanbulUC-NilaySener

Identifier Type: -

Identifier Source: org_study_id

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