Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2023
Source Universidad Politecnica de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study hypothesised that the Mindfulness Sports Performance Enhancement (MSPE) programme adapted for this population, was more effective than mindfulness-based relaxation training as a treatment for chronic pain and associated emotional disturbances in Para athletes with physical disabilities, and that it contributes more to modifying psychological variables that have been shown to be related to or have modulatory value in the experience of chronic pain.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental group (MSPE programme group).
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.
Control group (relaxation group).
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.

Locations

Country Name City State
Spain Sandra Constantino Murillo Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Politecnica de Madrid Universidad Politécnica de Madrid.

Country where clinical trial is conducted

Spain, 

References & Publications (9)

[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

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain