Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)

NCT ID: NCT06003712

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI

Detailed Description

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Conditions

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Spinal Cord Injuries Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Exercise Group

Subjects will participate in a one-month mindfulness breathing-exercise program

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Participants will engage in a 10-15 minute mindfulness exercise three times weekly for one month. This mindfulness exercise utilizes guided attention on the breath through an instructional video, aiming to cultivate calmness and alleviate stress.

Interventions

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Mindfulness

Participants will engage in a 10-15 minute mindfulness exercise three times weekly for one month. This mindfulness exercise utilizes guided attention on the breath through an instructional video, aiming to cultivate calmness and alleviate stress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult males and females aged 18-70 who are living with spinal cord injury
* C5 to the T10 levels
* Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D
* Eligible participants must be able to understand and provide consent, be in good health operationalized as free from acute treatable illness, pressure injury, and cardiovascular disease.

Exclusion Criteria

* Participants taking medications that alter chronotropic and pressor responses will be excluded.
* Pregnant women will not be eligible to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Eduard Tiozzo, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduard Tiozzo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami - Miami Project to Cure Paralysis

Miami, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Caroline Jones

Role: CONTACT

(904) 325-4707

Kayla Samimi

Role: CONTACT

(310) 855-44332

Other Identifiers

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20230705

Identifier Type: -

Identifier Source: org_study_id

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