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

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.

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.

Study Overview

• Status: Completed
• Conditions: Parent-Child Relations
• Intervention / Treatment: Other: Infant Massage course

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Elena Piñero Pinto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Parents with babies without Down Syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The parents of this group will receive 5 sessions of infant massage course (1 per week) between two measurements of the variables	Other: Infant Massage course; 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.
No Intervention: Control Group; The parents of this group will not receive infant massage course (1 per week) between two measurements of the variables. They will receive it after two measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Acceptance	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change fron Commitment	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Conscience of Influence	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: PIÑERO PINTO, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Down Syndrome; Acceptance; Commitment; Concience of influence
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome
• Other Study ID Numbers: EPinto - USeville

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No