The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level

Not Applicable

Recruiting

• Conditions: Stress, Psychological; Psoriasis; Depression; Anxiety
• Interventions: Behavioral: Psychological stress relief techniques

• Registration Number: NCT05894759
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

Brief Summary

Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Status Verified: 2023-06
• Study Start: 2023-06
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-09
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxing stories	Psychological stress relief techniques	Patients will listen to relaxing stories, online, for 1 month.
Music therapy	Psychological stress relief techniques	Patients will undergo music therapy, delivered online, for 1 month.

Primary Outcome Measures

Name	Time	Method
Psychological stress	6 months	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	6 months	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	6 months	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)
Dermatological Life Quality Index	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index	6 months	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)
The Revised Illness Perception Questionnaire	6 months	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	6 months	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)
Self Administered Psoriasis Area and Severity Index	6 months	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)

Trial Locations

Locations (1)

Saint Spiridon Emergency Clinical County Hospital- Dermatology department; 🇷🇴 Iasi, Romania