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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06003712
• Other study ID #: 20230705
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 31, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: Caroline Jones
• Phone: (904) 325-4707
• Email: cyj323[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Miami - Miami Project to Cure Paralysis	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart rate	heart 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	baseline, 1 month
Primary	Change in blood pressure	Blood 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	baseline, 1 month
Primary	Change in metabolism as measured by maximum oxygen consumption (VO2)	Metabolism 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	baseline, 1 month
Primary	Change in metabolism as measured by ventilation (VE)	Metabolism 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	baseline, 1 month
Secondary	Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III	A 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"	baseline, 1 month