The Quality of Life in Children at Social Risk, a Case Series Study Protocol
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|ClinicalTrials.gov Identifier: NCT05135780|
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
|Condition or disease||Intervention/treatment|
|Osteopathic Medicine Effectiveness||Other: Osteopathic manual treatment Other: Social education|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Phase Project (Fundació Albert Salut i Educació): Effects of a Multidisciplinary Intervention (Osteopathy and Social Work) on the Quality of Life in Children at Social Risk. A Case Series Protocol|
|Actual Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
- Other: Osteopathic manual treatment
Between 5 and 8 sessions of osteopathy will be carried out, and the time interval between sessions may vary depending on the need and individual evolution of each child, assessed by the team of osteopaths.
- Other: Social education
Intervention in children:
- During the school year there will be activities of two days per week with a duration of 2.5 hours per session in the afternoon.
- The activities will focus on school reinforcement, facilitating snacks and having a recreational space.
- Groups will be made by age ranges (from 4 to 6 and from 7 to 12) of maximum 10 children, due to the current COVID situation. The number could vary in the event of a change in measures at the institutional level.
- Quarterly tutoring spaces between the coordinators and the team of social educators to evaluate needs, specify objectives and assess evolution.
- Monthly group spaces for mothers managed by the team of educators where they will exchange experiences and create an informal support network.
- Monthly spaces shared between parents and children accompanied by the educational team, where family ties will be worked through play.
- Change in Pediatric Quality of Life Inventory (PedsQL) questionnaire [ Time Frame: -1rst questionnaire at baseline 2nd questionnaire in December 2021. - 3rd questionnaire in March 2022. - 4th questionnaire in June 2022. ]
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of self-report of health-related quality of life in pediatric patients with chronic health conditions. Is a 23-item generic health status instrument. Items are scored from 5-point Likert scale from 0 (Never) to 4 (Almost always) Scores then are transformed on a scale from 0 to 100. Step 1: Transform Score
Items are reversed scored and linearly transformed to a 0-100 scale as follows:
0=100, 1=75, 2=50, 3=25, 4=0. Mean score = Sum of the items over the number of items answered. If 50% or more items are completed: Impute the mean of the completed items in a scale.
- Number of Osteopathy sessions [ Time Frame: july 2022 ]Number of osteopathy sessions needed for each child and/or family.
- Change in Numerical Pain Scale [ Time Frame: At baseline and second measure at July 2022 ]The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135780
|Contact: Sonia Roura Carvajal, Mscfirstname.lastname@example.org|
|Sonia Roura Carvajal||Recruiting|
|La Seu d'Urgell, Spain, 25700|
|Contact: Sonia Roura Carvajal 619789589 email@example.com|
|Study Director:||Sonia Roura Carvajal, MsC||Sonia|