Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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7 December 2020 |
Main ID: |
ISRCTN14389453 |
Date of registration:
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29/06/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of self-perceived psychological and emotional well-being of young Paralympic athletes
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Scientific title:
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Do questionnaires on self-perceived psychological and emotional well-being administered to young Paralympic athletes, as compared to disabled people that do not practice agonistic sport, provide evidence of the positive role of agonistic sport?
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Date of first enrolment:
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01/09/2017 |
Target sample size:
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2400 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN14389453 |
Study type:
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Observational |
Study design:
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Single-centre cross-sectional study (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Albania
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Belgium
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Bulgaria
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Croatia
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Cyprus
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Iceland
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Ireland
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Israel
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Italy
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Latvia
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Luxembourg
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Montenegro
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Netherlands
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Norway
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Poland
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Portugal
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Romania
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Luca
Puce |
Address:
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Institute of Neurology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health
University of Genoa
L.go P. Daneo, 3
I-16132
Genoa
Italy |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Current participant inclusion criteria (as of 24/01/2018): Population under examination: 1. Participants in a national and international sport events, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy, the promotional Paralympic Swimming Italian Youth Paralympic Championship, April 29-30, 2017, Fabriano (An), Italy, and the Italian Paralympic Swimming Championship of sport clubs, May 20-21, 2017, Lignano Sabbiadoro (Ud), Italy 2. Age range 12-23 3. Both genders
Reference population of a similar number of subjects: 1. Young disabled people that do not practice agonistic sport 2. Recruited via clinics in Europe and at events for disabled peoples
Previous participant inclusion criteria: Population under examination: 1. Participants in an international event, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy 2. Age range 12-23 3. Both genders
Reference population of a similar number of subjects: 1. Young disabled people that do not practice agonistic sport 2. Recruited via clinics in Europe and at events for disabled peoples
Exclusion criteria: Aged under 12 or over 23 years old
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Physical disability Musculoskeletal Diseases Physical disability
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Intervention(s)
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Current Interventions (as of 24/01/2018): Participants include young Paralympic athletes from the European Para-Youth Games 2017, Paralympic Swimming Italian Youth Paralympic Championship 2017, and the Italian Paralympic Swimming Championship of sport clubs 2017, as well as a reference population. Participants are randomised as belonging to different European countries and age from 12 to 23 years old.
Participants at these events are administered the questionnaires to complete. The questionnaire includes the Psychological General Well-Being Index (PGWBI) and the Short Form SF-12 index questionnaires. These questionnaires are well established and validated scientific tools, used to assess the self-perceived psychological and emotional well-being of young Paralympic athletes as compared young disabled people that do not practice agonistic sports. The questionnaires take under 30 minutes to fill-in and they can be either self-administered or administered in the form of a face-to-face interview with the assistance of a relative. The survey is anonymous.
The reference population (that include disabled youth who do not practice sport) are recruited by contacting psychiatry clinics across European countries taking part in the events. In this case, contact people are identified and are given instructions for administration of the questionnaires and assistance. Moreover, the link to the questionnaires are posted in the web page of the event European Para-Youth Games 2017, which will be reached not only by disabled athletes, but also by disabled non-athletes. Social media (Facebook) will further disseminate the link to the questionnaire.
Both groups complete the same questionnaires.
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Primary Outcome(s)
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1. Psychological well-being is measured using the Psychological General Well-Being Index (PGWBI). 2. Emotional well-being is meaured using the Short Form SF-12 index.
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Secondary Outcome(s)
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1. Demographics (gender, age range, country, type of disability) are measured using questionnaires. 2. Physical well-being is measured using the Short Form SF-12 index
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Source(s) of Monetary Support
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University of Genoa, Funding will be obtained from a private sponsor of the event "European Para-Youth Games 2017". Negotiation to get financial support is underway with the company ERG (Edoardo Raffinerie Garrone - ERG S.p.a), via the regional section of the Italian Paralympic Committee, CIP-Liguria
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval as of 03/10/2017: Ethics committee CER-Liguria (regional ethical committee of region Liguria, Italy, 02/10/2017, ref: 351REG2017
Previous ethics approval: Ethic approval was not required, as this work is an observational study involving administration and answering of questionnaires, that are well-established and internationally validated scientific tools. No administration of drugs is involved. No formal procedures with ethics boards hav
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/09/2019 |
URL:
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