Athletic InjuriesNCT06184217

Effects of a Mindfulness Programme on Competitive Athletes With Physical Disabilities

A study testing Experimental group (MSPE programme group). in people with Athletic Injuries and Physical Disability, run by Universidad Politecnica de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 60 years
Conditions the study is for: Athletic Injuries, Physical Disability, Chronic Pain
What is being tested?: Experimental group (MSPE programme group).
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSpain
Study dates: 16 Nov 2022to 17 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

Not having at least one of the criteria mentioned as inclusion.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Sandra Constantino Murillo
Madrid, 28040

Other trials in Spain

About this study

Official title: Effects of the Mindfulness Sport Performance Enhancement Programme on Competitive Athletes With Physical Disabilities.

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.

Read the detailed 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.

Conditions: Athletic Injuries, Physical Disability, Chronic Pain
Being tested: Experimental group (MSPE programme group)., Control group (relaxation group).
Keywords: Athlete Injuries, Physical disability, Chronic pain, Psychological abilities, Mindfulness
Medical subject headings: Athletic Injuries, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental group (MSPE programme group).Other
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).Other
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.

Study groups in NCT06184217
Study group	Role	What they receive
Experimental group (MSPE programme group).	Experimental	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]. Receives: Other: Experimental group (MSPE programme group).
Control group (relaxation group).	Active comparator	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]. Receives: Other: Control group (relaxation group).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month and a half.
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).
Measured: Month and a half.

Secondary outcomes (1)

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:
1. Depression, Anxiety, and Stress Scales (DASS-21). The scale will assess the presence and intensity of affective states of depression, anxiety, and stress. [5].
2. 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.
3. Satisfaction with Life Scale (SWLS). The scale will assess satisfaction with life. [7].
Coping strategies:
1. Chronic Pain Acceptance Questionnaire (CPAQ). This questionnaire measures involvement in activities and openness to pain. ID: 21044544.
2. Coping Strategies Questionnaire (CSQ). This questionnaire will assess the frequency with which the subject uses different pain coping strategies. ID: 15042468
Measured: Month and a half.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202217 May 2023

First posted28 Dec 2023
Study start16 Nov 2022
Primary completion12 Apr 2023
Study completion17 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Athletic InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06184217
Sponsor's protocol ID: UPM
Status last verified: Dec 2023
First submitted: 26 Nov 2023
Last updated: 3 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

[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.
PubMed 22344492
[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.
PubMed 17296089
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.
PubMed 11011872
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.
PubMed 21044544
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.
PubMed 15042468

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Recruiting
Intelligent Sports Injury Prevention and Training System
Sport Injury
RecruitingObservational study
Multimodal Machine Learning for Predicting Reduced Participation in Elite Youth Football
Athletic Injury, Fatigue Recovery
Not yet recruitingObservational study
Investigation of Injury Risk and Related Factors in Adolescent Male Soccer Players
Injury;Sports, Athletic Injuries

All Athletic Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the Mindfulness Sport Performance Enhancement Programme on Competitive Athletes With Physical Disabilities.
ClinicalTrials.gov ID: NCT06184217
Acronym / sponsor ID: UPM
Conditions: Athletic Injuries, Physical Disability, Chronic Pain
Keywords: Athlete Injuries, Physical disability, Chronic pain, Psychological abilities, Mindfulness
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Universidad Politecnica de MadridUniversity, hospital or other
Study start: 16 Nov 2022 (actual)
Primary completion: 12 Apr 2023 (actual)
Study completion: 17 May 2023 (actual)
First posted: 28 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group (MSPE programme group).	Experimental	Other: 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].
Control group (relaxation group).	Active comparator	Other: 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].

Who may qualify

Ages: 15 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Not having at least one of the criteria mentioned as inclusion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Experimental group (MSPE programme group).
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.	Other	Control group (relaxation group).

Primary outcome

Change in pain intensity (current pain) post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No].
Time frame: Month and a half.
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.
Change in pain frequency post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]
Time frame: Month and a half.
The frequency with which Para-athletes experience pain will be assessed on a Likert-type scale from 1 (very infrequent) to 5 (very frequent).

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Background[1] Kaufman, K., Glass, C. R., & Pineau, T. R. (2018). Mindful sport performance enhancement: Mental training for athletes and coaches. American Psychological Association.
Background[2] Martín-Asuero (2008). On your own course. Enjoy life without stress. Platform.
Background[3] Bernstein, D., Borkovec, T., & Hazlett-Stevens, H. (2000). New Directions in Progressive Relaxation Training: A Guidebook for Helping Professionals. Bloomsbury Academic.
Background: PubMed 22344492Soler 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.
Background[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.
Background: PubMed 17296089Diaz 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.
Background: PubMed 11011872Pons 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.
Background: PubMed 21044544Gonzalez 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.
Background: PubMed 15042468Rodriguez 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.
Individual participant dataSharing planned: No

Related trials for Athletic Injuries

Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
Shoulder Injuries and Disorders, Elbow Injuries and Disorders
Recruiting
Intelligent Sports Injury Prevention and Training System
Sport Injury
RecruitingObservational study
Multimodal Machine Learning for Predicting Reduced Participation in Elite Youth Football
Athletic Injury, Fatigue Recovery
Not yet recruitingObservational study
Investigation of Injury Risk and Related Factors in Adolescent Male Soccer Players
Injury;Sports, Athletic Injuries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

María I. B Barriopedro, PhD in Psychology study director

Universidad Politecnica de Madrid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group (MSPE programme group). in people with Athletic Injuries and Physical Disability, run by Universidad Politecnica de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain intensity (current pain) post intervention. [Time Frame: Baseline and at 6 weeks].[Safety Issue: No]. (time frame: Month and a half.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06184217, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.