Study of self-perceived psychological and emotional well-being of young Paralympic athletes
| ISRCTN | ISRCTN14389453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14389453 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Genoa |
| Funders | 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 |
- Submission date
- 30/05/2017
- Registration date
- 29/06/2017
- Last edited
- 04/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
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
 ORCID ID |
0000-0003-0825-2707 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| 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? |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Psychological well-being is measured using the Psychological General Well-Being Index (PGWBI). |
| Key secondary outcome measure(s) |
1. Demographics (gender, age range, country, type of disability) are measured using questionnaires. |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Upper age limit | 23 Years |
| Sex | All |
| Target sample size at registration | 2400 |
| Total final enrolment | 200 |
| Key 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 years 3. Both genders Reference population of a similar number of subjects: 1. Young disabled people who 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 years 3. Both genders Reference population of a similar number of subjects: 1. Young disabled people who do not practice agonistic sport 2. Recruited via clinics in Europe and at events for disabled peoples |
| Key exclusion criteria | Aged under 12 or over 23 years old |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- United Kingdom
- 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
Study participating centre
Genoa
I-16132
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Data will be available on request from the principal investigator of this research Luca Puce at luca1puce@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/07/2023 | 04/07/2024 | Yes | No | |
| Protocol article | protocol | 13/11/2017 | 26/11/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/07/2024: Publication reference added.
26/11/2020: Publication reference added.
15/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 31/12/2017.
2. The total final enrolment number was added.
3. The intention to publish date was changed from 31/12/2019 to 30/09/2020.
4. Contact details updated.
21/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2018 to 30/04/2019
2. The overall trial end date was changed from 31/12/2018 to 30/09/2019
3. The intention to publish date was changed from 31/07/2018 to 31/12/2019
4. The intervention type was added
24/01/2018: The following changes were made:
1. Recruitment end date was changed from 31/12/2017 to 31/07/2018.
2. Overall trial end date was changed from 01/02/2018 to 31/12/2018.
3. Intention to publish date was changed from 01/04/2018 to 31/12/2019.
3. Interventions and participant inclusion criteria was updated.
03/10/2017: Ethics information has been updated.
