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Clinical Trials/NCT05642039
NCT05642039
Completed
N/A

Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients

University of Miami1 site in 1 country37 target enrollmentMay 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hidradenitis Suppurativa
Sponsor
University of Miami
Enrollment
37
Locations
1
Primary Endpoint
HS Quality of Life Measure (HiSQOL) Scores
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
August 21, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadar Lev-Tov

Associate Professor of Clinical

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation

Exclusion Criteria

  • Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations
  • Adults unable to consent
  • Pregnant women
  • Prisoners
  • Individuals below the age of 18 years old
  • Individuals who do not speak English

Outcomes

Primary Outcomes

HS Quality of Life Measure (HiSQOL) Scores

Time Frame: Up to 10 weeks

HS quality of life (HiSQOL) has a total score ranging from 0 to 68, with higher scores indicating more severe impact on participant's quality of life

Secondary Outcomes

  • Dermatology Life Quality Index (DLQI) Scores(Up to 10 weeks)
  • Number of participants at each Refined Hurley Classification(Up to 10 weeks)
  • Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores(Up to 10 weeks)
  • Number of Pain medication Usage(Up to 10 weeks)
  • Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores(Up to 10 weeks)
  • Number of work/school days missed(Up to 10 weeks)
  • Sleep Quality Scale (SQS) Scores(Up to 10 weeks)
  • Number of visits to the emergency room(Up to 10 weeks)
  • Pain Visual Analog Scale (VAS) Scores(Up to 10 weeks)

Study Sites (1)

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