NCT06184217

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 26, 2023

Last Update Submit

December 28, 2023

Conditions

Keywords

Athlete InjuriesPhysical disabilityChronic painPsychological abilitiesMindfulness

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 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.

    Month and a half.

Study Arms (2)

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 \[2\].

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 \[3\].

Other: Control group (relaxation group).

Interventions

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.

Experimental group (MSPE programme 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.

Control group (relaxation group).

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Constantino Murillo

Madrid, 28040, Spain

Location

Related 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.

    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
  • 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.

    PMID: 22344492BACKGROUND
  • [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
  • 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.

    PMID: 17296089BACKGROUND
  • 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.

    PMID: 11011872BACKGROUND
  • 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.

    PMID: 21044544BACKGROUND
  • 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.

    PMID: 15042468BACKGROUND

MeSH Terms

Conditions

Athletic InjuriesChronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • María I. B Barriopedro, PhD in Psychology

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 28, 2023

Study Start

November 16, 2022

Primary Completion

April 12, 2023

Study Completion

May 17, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations