High Cognitive AbilitiesNCT06695351
Pain in Subjects with High Capacity Cognitive Abilities
An observational study of High Cognitive Abilities and Pain, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- High Cognitive Abilities, Pain, Prevalence
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2024to Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People with a diagnosis of high cognitive abilities and spanish language
Who may be able to join
- People with a diagnosis of high cognitive abilities
Who cannot join
- People with incapacity to answer the questionnaire
- People that's not have a good level of Spanish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT contact
Spain1 site
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670
Roberto Ucero-Lozano, PhD, PT, MSc, CHT, +34646466265, roberto.ucero@universidadeuropea.es
Rubén Cuesta-Barriuso, PhD, PT, MSc, +34 607547274, cuestaruben@uniovi.es
About this study
Official title: Pain in Subjects with High Capacity Cognitive Abilities: a Cross Sectional Study
In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. With this study the investigators will try to know better pain experience in this population and chronic pain prevalence
Read the detailed description
It's said that people with high cognitive abilities suffered pain. However, there are no scientific literature. With this study the investigators would like to know better pain experience in this population. There are two target groups include inside this population that we consider to study: Children population and adults population.
The aim of this study is to know the prevalence of chronic pain in this population and to analize the pain experience of this population and the related psychosocial variables that can modify it, like catastrophicing, kinesiophobia, anxiety, quality of life and level of physical activity,
The investigators will use a questionnaire that includes different questionnaires like TSK-11SV, PCS, STAI, SF-36 and IPAQ and many question to evaluate the demographic factor of the sample and the prevalence
The investigators will do an statistical analysis to observe the relationship and the predictors factors
- Conditions
- High Cognitive Abilities, Pain, Prevalence
- Keywords
- high cognitive abilities, Pain, Prevalence, Kinesiophobia, Catastrophising, giftedness
- Medical subject headings
- Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GIFTED | Patients with high cognitive abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived quality of life
Perceived quality of life was measured with the 36Item Short Form Health Survey (SF-36) scale validated in Spanish. This self-administered scale consists of 36 items in eight domains: physical functioning, limitations due to physical problems, physical pain, social role or function, mental health, limitations due to emotional problems, vitality and general perception of health.
Measured: 1 day
Secondary outcomes (4)
Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK-11) was used to assess patients' fear of moving or engaging in physical activity. We used the Spanish version of this self-administered instrument, which consists of 11 items rated on a 4-point Likert scale. The total score ranges from 11 to 44, with higher values corresponding to a greater fear of being injured again by the movement. Scores of more than 27 points are considered high. The minimum detectable change of this instrument is 5.6
Measured: 1 day
Catastrophising
Catastrophism was assessed with the Pain Catastrophizing Scale. This scale is composed of 13 items rated on a scale from 0 to 4 points (a lower score indicates lower catastrophism). The questionnaire used is validated in Spanish
Measured: 1 day
Anxiety
Anxiety was evaluated with the validated Spanish version of the State-Trait Anxiety inventory (STAI) questionnaire. This measuring instrument has two self-assessment scales to measure two independent anxiety concepts: state and trait. Both scales have 20 items each, which are scored on a Likert scale having four possible replies (from 0 to 3). This questionnaire presents a good internal consistency in the Spanish version in anxiety/state (Cronbach's α = .90 - .93) and in anxiety/trait (Cronbach's α = .84 - .87)
Measured: 1 day
Physical activity
The instrument used to determine participants' PA level was the IPAQ short form. Total weekly amount of PA was calculated according to the method for computation of metabolic equivalent of task (MET)minutes/week, previously established in the IPAQ instructions for analysis and data processing of the questionnaire. Then, PA level was classified as: low (<600 METmin/week), moderate ( 600 METmin/week) and high ( 3000 METmin/week), following the same guidelines. This questionnaire has acceptable validity ( = 0.30, 95% CI: 0.23-0.36) and reliability (Spearman's =0.81, 95%CI:0.79-0.82) [30]. It has also been validated in Spain (r = 0.277; p < 0.05; 75% of specificity and sensibility; k = 0.33).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Cognitive AbilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Ucero Lozano, PT, PhD, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695351
- Sponsor's protocol ID
- GIFTEDNESS_Pain
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Subjects with High Capacity Cognitive Abilities: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06695351
- Acronym / sponsor ID
- GIFTEDNESS_Pain
- Conditions
- High Cognitive Abilities, Pain, Prevalence
- Keywords
- high cognitive abilities, Pain, Prevalence, Kinesiophobia, Catastrophising, giftedness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. With this study the investigators will try to know better pain experience in this population and chronic pain prevalence
Detailed description
It's said that people with high cognitive abilities suffered pain. However, there are no scientific literature. With this study the investigators would like to know better pain experience in this population. There are two target groups include inside this population that we consider to study: Children population and adults population.
The aim of this study is to know the prevalence of chronic pain in this population and to analize the pain experience of this population and the related psychosocial variables that can modify it, like catastrophicing, kinesiophobia, anxiety, quality of life and level of physical activity,
The investigators will use a questionnaire that includes different questionnaires like TSK-11SV, PCS, STAI, SF-36 and IPAQ and many question to evaluate the demographic factor of the sample and the prevalence
The investigators will do an statistical analysis to observe the relationship and the predictors factors
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GIFTED | – | –Patients with high cognitive abilities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with a diagnosis of high cognitive abilities and spanish language
Key inclusion criteria (1 listed)
- People with a diagnosis of high cognitive abilities
Key exclusion criteria (2 listed)
- People with incapacity to answer the questionnaire
- People that's not have a good level of Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived quality of life
Time frame: 1 day
Perceived quality of life was measured with the 36Item Short Form Health Survey (SF-36) scale validated in Spanish. This self-administered scale consists of 36 items in eight domains: physical functioning, limitations due to physical problems, physical pain, social role or function, mental health, limitations due to emotional problems, vitality and general perception of health.
4 secondary outcomes
Kinesiophobia
Time frame: 1 day
Catastrophising
Time frame: 1 day
Anxiety
Time frame: 1 day
Physical activity
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Cognitive Abilities and Pain, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT (+34 646466265, roberto.ucero@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived quality of life (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.