NCT03126734

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

12 days

First QC Date

April 20, 2017

Last Update Submit

April 25, 2017

Conditions

Keywords

Down SyndromeAcceptanceCommitmentConcience of influence

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

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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.

Experimental Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • PIÑERO PINTO, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

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

Locations