Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05135780 |
| Other study ID # |
26102021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Come Collaboration |
| Contact |
Sonia Roura Carvajal, Msc |
| Phone |
+34619789589 |
| Email |
soniaroura6[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
this case series study has the aim to observe the effect of a multidisciplinary intervention
(social accompaniment, school reinforcement and osteopathic treatment) on the quality of life
of children with social risk in primary school age.
Description:
To observe the effect of a multidisciplinary intervention (social accompaniment, school
reinforcement and osteopathic treatment) on the quality of life of children with social risk
in primary school age.
II. Secondary objectives
- Observe if the quality of life of children in whom an osteopathic intervention is
performed to the family, improves in relation to children who are not treated to the
family.
- Observe if the number of sessions has any impact on the evolution of the quality of life
of children.
- Observe whether age is an influential factor for improving children's quality of life.
- Observe the possible confounding factors that may influence the evolution of children's
quality of life. These factors are detailed later in the section on secondary variables.
- Observe if there is a decrease in pain, in children who refer it.
- Observe if there is an improvement in the different reasons for consultation.
- The coordination of the study and its different interventions will be carried out
from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the
Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to
bring the solidarity service closer to a more appropriate and closer district for
the patient at social risk. Having to move outside their environment, taking public
transport, language problems and comparative grievances with the utilitarians of a
private service turned out to be reasons for absenteeism and lack of commitment.
The transfer has been a success and we believe it is convenient to carry out the
study within the FA to preserve the location of the project and the comfort/safety
of users at social risk.
- The participating families will be referred, as is usually worked in this
foundation, by the Social Services Centers, other agents and social entities, CSMIJ
(Center for Mental Health of Children and Youth), CDIAP (Center for Development and
Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat
Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la
Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance
directly.
- The Covid protocol that is in force during the start of the study will be taken
into account.
- The coordination of the study and its different interventions will be carried out
from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the
Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to
bring the solidarity service closer to a more appropriate and closer district for
the patient at social risk. Having to move outside their environment, taking public
transport, language problems and comparative grievances with the utilitarians of a
private service turned out to be reasons for absenteeism and lack of commitment.
The transfer has been a success and we believe it is convenient to carry out the
study within the FA to preserve the location of the project and the comfort/safety
of users at social risk.
- The participating families will be referred, as is usually worked in this
foundation, by the Social Services Centers, other agents and social entities, CSMIJ
(Center for Mental Health of Children and Youth), CDIAP (Center for Development and
Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat
Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la
Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance
directly.
- The Covid protocol that is in force during the start of the study will be taken
into account.
- The coordination of the study and its different interventions will be carried out
from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the
Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to
bring the solidarity service closer to a more appropriate and closer district for
the patient at social risk. Having to move outside their environment, taking public
transport, language problems and comparative grievances with the utilitarians of a
private service turned out to be reasons for absenteeism and lack of commitment.
The transfer has been a success and we believe it is convenient to carry out the
study within the FA to preserve the location of the project and the comfort/safety
of users at social risk.
- The participating families will be referred, as is usually worked in this
foundation, by the Social Services Centers, other agents and social entities, CSMIJ
(Center for Mental Health of Children and Youth), CDIAP (Center for Development and
Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat
Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la
Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance
directly.
- The Covid protocol that is in force during the start of the study will be taken
into account.
- The coordination of the study and its different interventions will be carried out
from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the
Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to
bring the solidarity service closer to a more appropriate and closer district for
the patient at social risk. Having to move outside their environment, taking public
transport, language problems and comparative grievances with the utilitarians of a
private service turned out to be reasons for absenteeism and lack of commitment.
The transfer has been a success and we believe it is convenient to carry out the
study within the FA to preserve the location of the project and the comfort/safety
of users at social risk.
- The participating families will be referred, as is usually worked in this
foundation, by the Social Services Centers, other agents and social entities, CSMIJ
(Center for Mental Health of Children and Youth), CDIAP (Center for Development and
Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat
Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la
Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance
directly.
- The Covid protocol that is in force during the start of the study will be taken
into account.
- The coordination of the study and its different interventions will be carried out
from the AF. Carrer Consolat de Mar, 45. Barcelona.
- Osteopathic intervention will be performed in AF. It is decided to move the
Solidarity Osteopathy Service to the AF, outside the FOB Osteopathy Clinic, to
bring the solidarity service closer to a more appropriate and closer district for
the patient at social risk. Having to move outside their environment, taking public
transport, language problems and comparative grievances with the utilitarians of a
private service turned out to be reasons for absenteeism and lack of commitment.
The transfer has been a success and we believe it is convenient to carry out the
study within the FA to preserve the location of the project and the comfort/safety
of users at social risk.
- The participating families will be referred, as is usually worked in this
foundation, by the Social Services Centers, other agents and social entities, CSMIJ
(Center for Mental Health of Children and Youth), CDIAP (Center for Development and
Early Care), EAIA (Child and Adolescent Care Teams), public schools in the Ciutat
Vella district of the city of Barcelona (Cervantes, Angel Baixeras, Parc de la
Ciutadella, Alexandre Galí, Pere Vila), or families who have requested assistance
directly.
- The Covid protocol that is in force during the start of the study will be taken
into account.
