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

Parent-Child Relations Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126734
• Other study ID #: EPinto - USeville
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 25, 2017
• Start date: March 3, 2017
• Est. completion date: April 20, 2017

Study information

• Verified date: April 2017
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 20, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Parents with babies without Down Syndrome.

Related Conditions & MeSH terms

• Down Syndrome
• Parent-Child Relations

Intervention

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.

Locations

Country	Name	City	State
Spain	Elena Piñero Pinto	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Conscience of Influence	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)
Primary	Change from Acceptance	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)
Secondary	Change fron Commitment	Measure by "This is my baby" Interview	At the start and the end of the study (5 weeks)