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Not yet recruitingNCT06695351Updated Nov 19, 2024

Pain in Subjects with High Capacity Cognitive Abilities

An observational study in High Cognitive Abilities, Pain and Prevalence, sponsored by Universidad Europea de Madrid. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Universidad Europea de Madrid · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
150
Sex
All
01

Study 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. 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

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Conditions studied

  • High Cognitive Abilities
  • Pain
  • Prevalence

Keywords

  • high cognitive abilities
  • Pain
  • Prevalence
  • Kinesiophobia
  • Catastrophising
  • giftedness
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 301 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Universidad Europea de Madrid is the lead sponsor of 99 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People with a diagnosis of high cognitive abilities and spanish language

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People with a diagnosis of high cognitive abilities

Exclusion criteria

Exclusion Criteria:

  • People with incapacity to answer the questionnaire
  • People that's not have a good level of Spanish language
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • GIFTED

    Patients with high cognitive abilities

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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)

    Time frame: 1 day

  4. 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).

    Time frame: 1 day

Other outcomes

  1. Pain

    The perceived pain intensity was evaluated using the visual analogue scale. This scale has shown good reliability and validity for the assessment of pain intensity.18 This measuring instrument evaluates the intensity of pain on a 10 cm line (0 being "no pain" and 10 being "the worst pain"). Participants were asked to make a mark on the line to represent the average intensity of the usual joint pain they endure in the last 30 days. Similarly, they were asked to mark the maximum degree of pain they report in the last month.

    Time frame: 1 day

07

Study locations

1 site
  • Universidad Europea de Madrid
    Villaviciosa de Odón, Madrid 28670, Spain
    • Roberto Ucero-Lozano, PhD, PT, MSc, CHT · Contact · roberto.ucero@universidadeuropea.es · +34646466265
    • Rubén Cuesta-Barriuso, PhD, PT, MSc · Contact · cuestaruben@uniovi.es · +34 607547274
    • Roberto Ucero-Lozano, PhD, PT, MSc, CHT · Contact
    • Rubén Cuesta-Barriuso, PhD, PT, MSc · Contact
    • Alba Ortiz-Pérez · Contact
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695351
Lead sponsor
Universidad Europea de Madrid
Responsible party
Roberto Ucero Lozano, PT, PhD (PhD, PT, MSc, CHT, Universidad Europea de Madrid) — Principal investigator
First posted
Nov 19, 2024
Start date
Dec 2024 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Nov 19, 2024

Study contacts

Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT
Contact
roberto.ucero@universidadeuropea.es
+34 646466265
Rubén Cuesta-Barriuso, PhD, PT, MSc
Contact
cuesta.ruben@uniovi.es
+34607547274

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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