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Completed

NCT Number: NCT03126734

Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies

This study aims to analyze whether the course of infant massage serves as a tool to improve acceptance, commitment and awareness of influence of parents of babies with Down syndrome. These variables will be measure before and after the course of infant massage in the experimental group, investigators will make measurements with the same rate in the control group, but they will receive the course after the measurements.

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Key information

Conditions

Parent-Child Relations Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elena Piñero Pinto

Seville, 41013, Spain

About this study

In the present study, investigators propose to study the effects of infant massage in the levels of acceptance, commitment and awareness of influence of parents of babies with Down syndrome. The measuring instrument of acceptance, commitment and awareness of parental influence will be the "This is my baby Interview". Two groups of intervention will be analysed, the experimental, in which parents have participated and applied the knowledge learned in the course of infant massage, and control, which does not receive the infant massage course during the study. Parents and babies of both groups have been evaluated twice, at the beginning of the intervention (pretest) and at the end after five weeks (postest). The study population consists of father or mother of 32 infants with Down syndrome between 4 and 8 months old.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parents with babies with Down Syndrome between 4 and 8 months old.

Exclusion criteria

  • Parents with babies without Down Syndrome.

Treatment and study plan

Infant Massage course

Other

Infant massage courses consist of 5 sessions. Investigators explain parents how to make an infant massage technique to their babies and which should be the general conditions of the environment.

This massage is based on the methodology of the International Association of infant massage (IAIM) created by Vimala Schnneider. The courses will make individually.

Primary outcomes

  1. Change from Acceptance

    Time frame: At the start and the end of the study (5 weeks)

    Measure by "This is my baby" Interview

Secondary outcomes

  1. Change fron Commitment

    Time frame: At the start and the end of the study (5 weeks)

    Measure by "This is my baby" Interview

Other outcomes

  1. Change from Conscience of Influence

    Time frame: At the start and the end of the study (5 weeks)

    Measure by "This is my baby" Interview

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Effects on Acceptance, Commitment and Awareness of Influence of Parents of Babies With Down Syndrome, After Participation in a Course of Infant Massage. Study on the Spanish Population.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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