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.
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedApril 27, 2017
April 1, 2017
12 days
April 20, 2017
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Acceptance
Measure by "This is my baby" Interview
At the start and the end of the study (5 weeks)
Secondary Outcomes (1)
Change fron Commitment
At the start and the end of the study (5 weeks)
Other Outcomes (1)
Change from Conscience of Influence
At the start and the end of the study (5 weeks)
Study Arms (2)
Experimental Group
EXPERIMENTALThe parents of this group will receive 5 sessions of infant massage course (1 per week) between two measurements of the variables
Control Group
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Parents with babies with Down Syndrome between 4 and 8 months old.
You may not qualify if:
- Parents with babies without Down Syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elena Piñero Pinto
Seville, 41013, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PIÑERO PINTO, PhD
University of Seville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 24, 2017
Study Start
March 3, 2017
Primary Completion
March 15, 2017
Study Completion
April 20, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share