- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695351
Pain in Subjects with High Capacity Cognitive Abilities
Pain in Subjects with High Capacity Cognitive Abilities: a Cross Sectional Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Roberto Ucero-Lozano, PhD, PhD, PT, MSc, CHT
- Phone Number: +34 646466265
- Email: roberto.ucero@universidadeuropea.es
Study Contact Backup
- Name: Rubén Cuesta-Barriuso, PhD, PT, MSc
- Phone Number: +34607547274
- Email: cuesta.ruben@uniovi.es
Study Locations
-
-
Madrid
-
Villaviciosa de Odón, Madrid, Spain, 28670
- Universidad Europea de Madrid
-
Contact:
- Roberto Ucero-Lozano, PhD, PT, MSc, CHT
- Phone Number: +34646466265
- Email: roberto.ucero@universidadeuropea.es
-
Contact:
- Rubén Cuesta-Barriuso, PhD, PT, MSc
- Phone Number: +34 607547274
- Email: cuestaruben@uniovi.es
-
Contact:
- Roberto Ucero-Lozano, PhD, PT, MSc, CHT
-
Contact:
- Rubén Cuesta-Barriuso, PhD, PT, MSc
-
Contact:
- Alba Ortiz-Pérez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- People with a diagnosis of high cognitive abilities
Exclusion Criteria:
- People with incapacity to answer the questionnaire
- People that's not have a good level of Spanish language
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
GIFTED
Patients with high cognitive abilities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: 1 day
|
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
|
1 day
|
|
Catastrophising
Time Frame: 1 day
|
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
|
1 day
|
|
Anxiety
Time Frame: 1 day
|
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)
|
1 day
|
|
Physical activity
Time Frame: 1 day
|
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).
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GIFTEDNESS_Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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