The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level
Primary Purpose
Psoriasis, Stress, Psychological, Depression
Status
Recruiting
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Psychological stress relief techniques
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of psoriasis adequate psychological stress profile access to a personal computer/ laptop/ smartphone with internet connection agreement to the informed consent form Exclusion Criteria: other dermatological conditions which impair the life quality psychological disorders under psychiatric treatment hearing impairment other on-going medical studies pregnancy aliteracy
Sites / Locations
- Saint Spiridon Emergency Clinical County Hospital- Dermatology departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Music therapy
Relaxing stories
Treatment as usual
Arm Description
Patients will undergo music therapy, delivered online, for 1 month.
Patients will listen to relaxing stories, online, for 1 month.
Dermatological treatment as per national guidelines.
Outcomes
Primary Outcome Measures
Dermatological Life Quality Index
Dermatological Life Quality Index Score will be calculated at baseline, 1 month and 6 months.
Dermatological Life Quality Index minimum score = 0 (no impairment of life quality) Dermatological Life Quality Index maximum score = 30 (maximum impairment of life quality)
Psychological stress
A visual analog scale will be used at baseline, 1 month and 6 months. Analog scale minimum value = 0 (no stress) Analog scale maximum value = 10 (maximum stress)
General Anxiety Disorder-7
General Anxiety Disorder-7 questionnaire will be applied at baseline, 1 month and 6 months.
General anxiety disorded-7 minimum score = 0 (no anxiety) General anxiety disorded-7 maximum score = 21 (maximum anxiety)
Patient Health Questionnaire-9
Patient Health Questionnaire-9 will be applied at baseline, 1 month and 6 months.
Patient Health Questionnaire-9 minimum score = 0 (no depression) Patient Health Questionnaire-9 maximum score = 27 (maximum depression)
Secondary Outcome Measures
Psoriasis Area and Severity Index
Psoriasis Area and Severity Index score will be calculated will be applied at baseline, 1 month and 6 months.
Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) Psoriasis Area and Severity Index maximum score = 72 (maximum severity)
Self Administered Psoriasis Area and Severity Index
The self Administered Psoriasis Area and Severity Index score will be calculated by the patient at baseline, 1 month and 6 months.
The self Administered Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) The self Administered Psoriasis Area and Severity Index maximum score = 72 (maximum severity)
The Revised Illness Perception Questionnaire
The Revised Illness Perception Questionnaire will be applied at baseline, 1 month and 6 months.
The Revised Illness Perception Questionnaire minimum score = 0 (best illness perception) The Revised Illness Perception Questionnaire maximum score = 80 (worst illness perception)
Dermatological treatment compliance
A visual analog scale will be applied at baseline, 1 month and 6 months. Analog scale minimum value = 0 (total lack of compliance) Analog scale maximum value = 10 (maximum compliance)
Full Information
NCT ID
NCT05894759
First Posted
May 17, 2023
Last Updated
June 7, 2023
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT05894759
Brief Title
The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level
Official Title
Psychodermatological Approaches of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grigore T. Popa University of Medicine and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Stress, Psychological, Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Patients will undergo music therapy, delivered online, for 1 month.
Arm Title
Relaxing stories
Arm Type
Sham Comparator
Arm Description
Patients will listen to relaxing stories, online, for 1 month.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Dermatological treatment as per national guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Psychological stress relief techniques
Intervention Description
Psychological stress relief techniques
Primary Outcome Measure Information:
Title
Dermatological Life Quality Index
Description
Dermatological Life Quality Index Score will be calculated at baseline, 1 month and 6 months.
Dermatological Life Quality Index minimum score = 0 (no impairment of life quality) Dermatological Life Quality Index maximum score = 30 (maximum impairment of life quality)
Time Frame
6 months
Title
Psychological stress
Description
A visual analog scale will be used at baseline, 1 month and 6 months. Analog scale minimum value = 0 (no stress) Analog scale maximum value = 10 (maximum stress)
Time Frame
6 months
Title
General Anxiety Disorder-7
Description
General Anxiety Disorder-7 questionnaire will be applied at baseline, 1 month and 6 months.
General anxiety disorded-7 minimum score = 0 (no anxiety) General anxiety disorded-7 maximum score = 21 (maximum anxiety)
Time Frame
6 months
Title
Patient Health Questionnaire-9
Description
Patient Health Questionnaire-9 will be applied at baseline, 1 month and 6 months.
Patient Health Questionnaire-9 minimum score = 0 (no depression) Patient Health Questionnaire-9 maximum score = 27 (maximum depression)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index
Description
Psoriasis Area and Severity Index score will be calculated will be applied at baseline, 1 month and 6 months.
Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) Psoriasis Area and Severity Index maximum score = 72 (maximum severity)
Time Frame
6 months
Title
Self Administered Psoriasis Area and Severity Index
Description
The self Administered Psoriasis Area and Severity Index score will be calculated by the patient at baseline, 1 month and 6 months.
The self Administered Psoriasis Area and Severity Index minimum score = 0 (no severity - no lesions) The self Administered Psoriasis Area and Severity Index maximum score = 72 (maximum severity)
Time Frame
6 months
Title
The Revised Illness Perception Questionnaire
Description
The Revised Illness Perception Questionnaire will be applied at baseline, 1 month and 6 months.
The Revised Illness Perception Questionnaire minimum score = 0 (best illness perception) The Revised Illness Perception Questionnaire maximum score = 80 (worst illness perception)
Time Frame
6 months
Title
Dermatological treatment compliance
Description
A visual analog scale will be applied at baseline, 1 month and 6 months. Analog scale minimum value = 0 (total lack of compliance) Analog scale maximum value = 10 (maximum compliance)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of psoriasis
adequate psychological stress profile
access to a personal computer/ laptop/ smartphone with internet connection
agreement to the informed consent form
Exclusion Criteria:
other dermatological conditions which impair the life quality
psychological disorders under psychiatric treatment
hearing impairment
other on-going medical studies
pregnancy
aliteracy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan-Marian Tarcau
Phone
0749872910
Ext
+40
Email
bogdan-marian.tarcau@d.umfiasi.ro
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Gheuca Solovastru, Prof.
Organizational Affiliation
Grigore T. Popa University of Medicine and Pharmacy Iasi
Official's Role
Study Director
Facility Information:
Facility Name
Saint Spiridon Emergency Clinical County Hospital- Dermatology department
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan-Marian Tarcau
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level
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