Plain English Summary
Background and study aims
The psychological well-being of an individual is defined by the dynamic balance between personal needs and the external environment. In the case of disabled people, their usually is a natural unbalance of needs/potentialities and environment which makes it even more urgent to pursue the enhancement of psychological (mental) well-being, addressing the integration in a positive and gratifying context that could promote personal evolution. Sport activities, especially at agonistic (individual or team sports) level, are likely the most effective means for the practical realisation of this strategy. The aim of this study is to investigate whether agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.
Who can participate?
Youth aged 12 to 23 who are participating in the European Para-Youth Games 2017, 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, and young disabled people who do not practice agonistic sports.
What does the study involve?
Participants are asked to fill in a questionnaire to assess their mental and emotional well-being. This can be done in person, online, or face to face using the assistance of a relative. The results from the Paralympic athletes are compared to the results of the reference population which is the young disabled people who do not practice agonistic sports.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
This study is run by the Institute of Neurology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genoa (Italy)
When is the study starting and how long is it expected to run for?
April 2017 to December 2018
Who is funding the study?
University of Genoa (Italy)
Who is the main contact?
Dr Luca Puce
luca1puce@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Luca Puce
ORCID ID
http://orcid.org/0000-0003-0825-2707
Contact details
Institute of Neurology
Department of Neuroscience
Rehabilitation
Ophthalmology
Genetics
Maternal and Child Health
University of Genoa
L.go P. Daneo
3
Genoa
I-16132
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
None
Study information
Scientific title
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?
Acronym
Study hypothesis
The aim of this study is to investigate whether agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.
Ethics approval
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 have been registered.
Study design
Single-centre cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Physical disability
Intervention
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.
Previous Interventions:
Participants include young Paralympic athletes from the European Para-Youth Games 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 the European Para-Youth Games 2017 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 event (European Para-Youth Games, 9-15 October 2017). 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.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/04/2017
Overall trial end date
30/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Other
Age group
Other
Gender
Both
Target number of participants
800-1200 for the population under study and equal number for the reference population
Total final enrolment
200
Participant exclusion criteria
Aged under 12 or over 23 years old
Recruitment start date
01/09/2017
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Albania, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Luxembourg, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Trial participating centre
Institute of Neurology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genoa, Genoa, Italy
L.go P. Daneo, 3
Genoa
I-16132
Italy
Funders
Funder type
University/education
Funder name
University of Genoa
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
As for dissemination, the close relationship of this project with an international event (European Para-Youth Games, 9-15 October 2017, Liguria, Italy) that will be given very broad media coverage will provide a natural dissemination channel through the media themselves. Furthermore, the principal investigator of this project being part of the organization staff of the event will further enhance the dissemination potential of this close relationship.
A press conference of announcement of the event has already taken place 24 and therein the forthcoming collaboration of the organization of the event with the institution of the authors of the present work (University of Genoa) was pointed out. Similarly, articles appeared on general-scope newspapers and news sites have mentioned this collaboration. It is plausible to assume that this represents the beginning of a significant media coverage from mainstream news channels, through press releases. Moreover, information about this project will be conveyed not only on the official web site of the event but also on the web sites of all the involved organizations (International Paralympic Committee IPC, Italian Paralympic Committee CIP, Italian Federation of Paralympic Swimming FINP, Italian Federation of Paralympic and Experimental Sports FISPES, Italian Federation of Paralympic Sport for Intellectual and Relational Disabilities FISDIR, Italian Federation of Paralympic Sport for visually impairment disabilities FISPIC, Italian Federation of Archery FITARCO, Italian Federation of Sailing FIV, Italian Federation of Table Tennis FITET). Finally dissemination via social networks will be also extensive (hashtag #epyg2017).
The results of this work will be also published on scientific medical journals whose mission is related to quality of life and sport and presented at scientific congresses.
IPD sharing statement:
Data will be available on request from the principal investigator of this research Luca Puce at luca1puce@gmail.com
Intention to publish date
30/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list