Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients

Burns Clinical Trial

Official title:

Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885321
• Other study ID #: 202212108RINC
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: YUN SHAN CHOU
• Phone: 886-972020895
• Email: sam573420028184[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pruritus, post traumatic stress disorder and perceived stress are common issues in burn patients. The correlation between the three is unclear so far.

This study will collect data among adult patients with hypertrophic scars 21 days after the burn event has occurred. Using a Chinese version of the 5D itch scale,Chinese version of the posttraumatic diagnostic scale and Perceived Stress Scale to investigate self-reported postburn pruritus,post traumatic stress disorder and perceived stress. The patients will be wearing the smart watch for one month to collect data on their stress levels. This data will be used to analyze the correlation between posttraumatic stress syndrome, perceived stress and scar pruritus. There will be two rounds of data collection. The first will be when the smart watch is issued to patients, and the second will be at the end of the one month period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hypertrophic scars 21 days after the burn event occurred

• Adult patients over 18 years old

• Patients without serious mental disorders, and are able to express themselves in Chinese with clear consciousness.

• The patient has no open wound on the wrist and is able to wear the smart watch continuously for one month

Exclusion Criteria:

• Patients with first-degree burns

• Non-traumatic electrical burns

Related Conditions & MeSH terms

• Burns
• Perceived Stress
• Post Traumatic Stress Disorder
• Pruritus
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Chinese version of the 5D itch scale	mmeasure the scar pruritus in burn patients,This scale including 5 domains: duration, degree, direction, disability and distribution. The duration, degree and direction domains each included one item, while the disability domain had four items. All items of the first four domains were measured on a five-point Likert scale.The distribution domain included 16 potential locations of itch,The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).	up to one months
Primary	Chinese version of Perceived Stress Scale	measure the Perceived Stress in burn patients,The Perceived Stress Scale consists of 14 items ,The scale can cluster into two subscales: negative subscale (items 1,2,3,8,11,12 and 14) and positive subscale (items 4,5,6,7,9,10 and 13), Each item is rated on a five-point scale from 0 = 'never' to 4 = 'very often', covering the preceding month	up to one months
Primary	Chinese version of the post traumatic diagnostic scale for DSM-5	measure the post traumatic stress in burn patients,a cutoff score of 28 for identifying a probable PTSD diagnosis	up to one months
Primary	garmin_Vivosmart 3	measure the Stress in burn patients By analyzing heart rate variability, a device can provide an assessment of an individual's overall general life stress. The stress level is measured on a scale from 0 to 100, where 0 to 25 represents a resting state, 26 to 50 indicates low stress, 51 to 75 signifies medium stress, and 76 to 100 indicates a high stress state. This device enables users to view their all-day stress levels as well as observe long-term trends.	up to one months