- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06184217
Effects of a Mindfulness Programme on Competitive Athletes With Physical Disabilities
Effects of the Mindfulness Sport Performance Enhancement Programme on Competitive Athletes With Physical Disabilities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28040
- Sandra Constantino Murillo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group (MSPE programme group).
Experimental (MSPE group).
The experimental group received the Mindful Sport Performance Enhancement programme (MSPE), with some changes and adaptations taking into account the characteristics and needs of the Para-athletes and the overall aim of the study.
Such as reducing the session time (2h), including staff and support material, extending the pre-session time (35-40 min), and incorporating the dynamics of emotions and Mindful Yoga into the floor of the MBSR programme [2].
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Experimental group.
MSPE Programme.
This group will receive a face-to-face mindfulness MSPE programme for 6 weeks, once a week for 1h 50min-2 hours.
In addition to doing mindfulness activities at home.
Each session contains the following exercises: (1) intention meditation, sultana exercise, diaphragmatic breathing and sitting meditation with a focus on breath, body and sound; (2) diaphragmatic breathing, Body Scan; (3) sitting meditation, dynamics of emotions, Mindful Yoga on the floor; (4) letting go of attachments, mindful Yoga on the floor walking meditation; (5) sports meditation, sitting meditation with a focus on breath, body and sound; (6) intention meditation, body scan analysis and review of sports meditation.
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Active Comparator: Control group (relaxation group).
Control group.
Control group.
Athletes with physical disabilities participating in the home were provided with a guide to body awareness-based relaxation training guidelines [3].
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These instructions included a combination of tension-relaxation of specific muscles and simple breathing techniques.
They were recommended to do this on a daily basis, with a minimum of 4 sessions per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity (current pain) post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No].
Time Frame: Month and a half.
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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.
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Month and a half.
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Change in pain frequency post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]
Time Frame: Month and a half.
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The frequency with which Para-athletes experience pain will be assessed on a Likert-type scale from 1 (very infrequent) to 5 (very frequent).
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Month and a half.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome Measure. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]. Higher values reflect higher levels on the scale to be measured.
Time Frame: Month and a half.
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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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Collaborators and Investigators
Collaborators
Investigators
- Study Director: María I. B Barriopedro, PhD in Psychology, Universidad Politécnica de Madrid.
Publications and helpful links
General Publications
- 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.
- 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.
- [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.
- 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.
- [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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPM
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
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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