Skip to content

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

Exploring the Effects of a Mindfulness-Based Intervention on Physiologic and Quality of Life Markers in Individuals With Spinal Cord Injury (SCI): A Pre-post Test Design

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003712
Enrollment
0
Registered
2023-08-22
Start date
2026-08-01
Completion date
2026-12-31
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Spinal Cord Injuries

Brief summary

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

Interventions

BEHAVIORALMindfulness

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Heart ratebaseline, 1 monthheart rate will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. Heart rate will be recorded in beats per minute
Change in blood pressurebaseline, 1 monthBlood pressure (BP) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. BP will be collected as systolic over diastolic in mmHg units
Change in metabolism as measured by maximum oxygen consumption (VO2)baseline, 1 monthMetabolism as determined by oxygen consumption (VO2) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VO2 is collected as mL/kg/min
Change in metabolism as measured by ventilation (VE)baseline, 1 monthMetabolism as determined by oxygen consumption (VE) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VE is measured in L/min

Secondary

MeasureTime frameDescription
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version IIIbaseline, 1 monthA composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant"

Contacts

PRINCIPAL_INVESTIGATOREduard Tiozzo, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026