Parent-Child RelationsNCT03126734
Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies
A study testing Infant Massage course in people with Parent-Child Relations, run by University of Seville at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Infant Massage course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2017to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents with babies with Down Syndrome between 4 and 8 months old.
Who cannot join
- Parents with babies without Down Syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Parent-Child Relations
- Being tested
- Infant Massage course
- Keywords
- Down Syndrome, Acceptance, Commitment, Concience of influence
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Massage courseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Acceptance
Measure by "This is my baby" Interview
Measured: At the start and the end of the study (5 weeks)
Secondary outcomes (1)
Change fron Commitment
Measure by "This is my baby" Interview
Measured: At the start and the end of the study (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start3 Mar 2017
- Primary completion15 Mar 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Piñero Pinto, University of Seville
- Investigators
- PIÑERO PINTO, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126734
- Sponsor's protocol ID
- EPinto - USeville
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03126734
- Acronym / sponsor ID
- EPinto - USeville
- Conditions
- Parent-Child Relations
- Keywords
- Down Syndrome, Acceptance, Commitment, Concience of influence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Infant Massage courseThe parents of this group will receive 5 sessions of infant massage course (1 per week) between two measurements of the variables |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents with babies with Down Syndrome between 4 and 8 months old.
Key exclusion criteria (1 listed)
- Parents with babies without Down Syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Massage courseInfant 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. | Other | Experimental Group |
Primary outcome
Change from Acceptance
Time frame: At the start and the end of the study (5 weeks)
Measure by "This is my baby" Interview
1 secondary outcome
Change fron Commitment
Time frame: At the start and the end of the study (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIÑERO PINTO, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage course in people with Parent-Child Relations, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Acceptance (time frame: At the start and the end of the study (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.