Chronic Pain Clinical Trial
Official title:
Effects of the Mindfulness Sport Performance Enhancement Programme on Competitive Athletes With Physical Disabilities.
NCT number | NCT06184217 |
Other study ID # | UPM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 16, 2022 |
Est. completion date | May 17, 2023 |
Verified date | December 2023 |
Source | Universidad Politecnica de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pain affects the athlete's sporting career directly or indirectly. Directly, the injury affects other areas of the body causing a physical decompensation in the athlete and this affects the correct execution of the sporting technique, or how technical gestures can cause pain. Indirectly, through the psychological consequences of pain that generate a series of negative consequences and feelings. Some studies suggest that psychological skills are an important tool for pain management. For that reason, a mindfulness intervention programme would be a useful tool for manage pain in this population.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 17, 2023 |
Est. primary completion date | April 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 60 Years |
Eligibility | Inclusion Criteria: - Have a physical disability - A minimum of 5 points on a Likert-type scale from 1 (no pain) to 10 (worst pain imaginable) at the time of recruitment - Be at least 15 years of age - Have been a competitive athlete (regional, national, world and/or Paralympic Games level) in any sport discipline. - Have an official regional or Spanish Federation of Sports for People with Physical disabilities licence - Be willing to participate in a mindfulness programme for pain management - Sign an informed consent form. Exclusion Criteria: - Not having at least one of the criteria mentioned as inclusion. |
Country | Name | City | State |
---|---|---|---|
Spain | Sandra Constantino Murillo | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Politecnica de Madrid | Universidad Politécnica de Madrid. |
Spain,
[1] Kaufman, K., Glass, C. R., & Pineau, T. R. (2018). Mindful sport performance enhancement: Mental training for athletes and coaches. American Psychological Association.
[2] Martín-Asuero (2008). On your own course. Enjoy life without stress. Platform.
[3] Bernstein, D., Borkovec, T., & Hazlett-Stevens, H. (2000). New Directions in Progressive Relaxation Training: A Guidebook for Helping Professionals. Bloomsbury Academic.
[5] Daza P, Novy DM, Stanley MA, Averill P. The depression, anxiety, stress-21 scale: translation and validation into Spanish with a Hispanic sample. Journal of Psychopathology and Behavioral Assessment. 2002; 24(3): 195-205.
Diaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish. — View Citation
Gonzalez Menendez A, Fernandez Garcia P, Torres Viejo I. [Acceptance of chronic pain in fibromyalgia patients: adaptation of Chronic Pain Acceptance Questionnaire (CPAQ) in a Spanish population]. Psicothema. 2010 Nov;22(4):997-1003. Spanish. — View Citation
Pons D, Atienza FL, Balaguer I, Garcia-Merita ML. Satisfaction with life scale: analysis of factorial invariance for adolescents and elderly persons. Percept Mot Skills. 2000 Aug;91(1):62-8. doi: 10.2466/pms.2000.91.1.62. — View Citation
Rodriguez Franco L, Cano Garcia FJ, Blanco Picabia A. [Assessment of chronic pain coping strategies]. Actas Esp Psiquiatr. 2004 Mar-Apr;32(2):82-91. Spanish. — View Citation
Soler J, Tejedor R, Feliu-Soler A, Pascual JC, Cebolla A, Soriano J, Alvarez E, Perez V. Psychometric proprieties of Spanish version of Mindful Attention Awareness Scale (MAAS). Actas Esp Psiquiatr. 2012 Jan-Feb;40(1):19-26. Epub 2012 Jan 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain intensity (current pain) post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]. | The presence of pain intensity (current pain) will be measured on a visual analogue Likert-type rating scale from 1 (no pain) to 10 (worst pain imaginable) without and with sports practice. A higher score indicates greater intensity. | Month and a half. | |
Primary | Change in pain frequency post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No] | The frequency with which Para-athletes experience pain will be assessed on a Likert-type scale from 1 (very infrequent) to 5 (very frequent). | Month and a half. | |
Secondary | Secondary Outcome Measure. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]. Higher values reflect higher levels on the scale to be measured. | Mindfulness: 2. Mindful Attention Awareness Scale (MAAS). The scale will assess the individual's ability to be attentive and aware of the present moment experience in everyday life. ID: 22344492.
Mental health variables: 3. Depression, Anxiety, and Stress Scales (DASS-21). The scale will assess the presence and intensity of affective states of depression, anxiety, and stress. [5]. 4. Scales of Psychological Well-Being (SPWBP). The scale will assess the six dimensions postulated in the multidimensional model of psychological well-being. ID de PubMed: 17296089. 5. Satisfaction with Life Scale (SWLS). The scale will assess satisfaction with life. [7]. Coping strategies: 6. Chronic Pain Acceptance Questionnaire (CPAQ). This questionnaire measures involvement in activities and openness to pain. ID: 21044544. 7. Coping Strategies Questionnaire (CSQ). This questionnaire will assess the frequency with which the subject uses different pain coping strategies. ID: 15042468 |
Month and a half. |
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