Back to resultsEffects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies
Primary Purpose
Parent-Child Relations
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Infant Massage course
Sponsored by
About this trial
This is an interventional treatment trial for Parent-Child Relations focused on measuring Down Syndrome, Acceptance, Commitment, Concience of influence
Eligibility Criteria
Inclusion Criteria:
- Parents with babies with Down Syndrome between 4 and 8 months old.
Exclusion Criteria:
- Parents with babies without Down Syndrome.
Sites / Locations
- Elena Piñero Pinto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
The parents of this group will receive 5 sessions of infant massage course (1 per week) between two measurements of the variables
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.
Outcomes
Primary Outcome Measures
Change from Acceptance
Measure by "This is my baby" Interview
Secondary Outcome Measures
Change fron Commitment
Measure by "This is my baby" Interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126734
Brief Title
Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-Child Relations
Keywords
Down Syndrome, Acceptance, Commitment, Concience of influence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The parents of this group will receive 5 sessions of infant massage course (1 per week) between two measurements of the variables
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Infant Massage course
Intervention Description
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 Outcome Measure Information:
Title
Change from Acceptance
Description
Measure by "This is my baby" Interview
Time Frame
At the start and the end of the study (5 weeks)
Secondary Outcome Measure Information:
Title
Change fron Commitment
Description
Measure by "This is my baby" Interview
Time Frame
At the start and the end of the study (5 weeks)
Other Pre-specified Outcome Measures:
Title
Change from Conscience of Influence
Description
Measure by "This is my baby" Interview
Time Frame
At the start and the end of the study (5 weeks)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parents with babies with Down Syndrome between 4 and 8 months old.
Exclusion Criteria:
Parents with babies without Down Syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PIÑERO PINTO, PhD
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elena Piñero Pinto
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies
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