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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05642039
Other study ID # 20220907
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date August 31, 2024

Study information

Verified date January 2024
Source University of Miami
Contact Aliette Espinosa
Phone 305-689-3376
Email a.espinosa2@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness Course
Participants will attend a weekly 1.5-hour class over a 6-week period via Zoom. Participants will also be required to listen to guided practice audio recordings that are 12-20 minutes long and complete a weekly homework log detailing all audio recordings completed.
HS Educational Course
Participants will meet for 10 -15 minutes once a week over a 6-week period. The course will be administered verbally or with the use of PowerPoint slides.

Locations

Country Name City State
United States University of Miami 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 HS Quality of Life Measure (HiSQOL) Scores 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 Up to 10 weeks
Secondary Dermatology Life Quality Index (DLQI) Scores Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life Up to 10 weeks
Secondary Number of participants at each Refined Hurley Classification The Hurley Classification is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening normal skin). Up to 10 weeks
Secondary Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores HS Physician's Global Assessment (HS-PGA) Scale is a 6-point Likert scale from 0 (clear) to 5 (very severe). Total score ranges from 0 to 30 with the higher score indicating more severe HS symptoms Up to 10 weeks
Secondary Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores FFMQ-SF has total scores ranging from 15 to 75. Higher scores indicate greater levels of mindfulness. Up to 10 weeks
Secondary Pain Visual Analog Scale (VAS) Scores Pain VAS has a range from 0 to 10 with a higher score indicating worse pain Up to 10 weeks
Secondary Sleep Quality Scale (SQS) Scores Sleep Quality Scale (SQS) has a score ranging from 0-10 with a greater score indicating greater sleep quality Up to 10 weeks
Secondary Number of Pain medication Usage Patient reported number of pain medications used by participants in the past week Up to 10 weeks
Secondary Number of work/school days missed Patient reported number of work/school days missed in the past week Up to 10 weeks
Secondary Number of visits to the emergency room Patient reported number of visits to the emergency room in the past week Up to 10 weeks
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