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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05885321
Collaborator
(none)
100
1
9.9
10.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients
    Actual Study Start Date :
    Mar 6, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. the Chinese version of the 5D itch scale [up to one months]

      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).

    2. Chinese version of Perceived Stress Scale [up to one months]

      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

    3. Chinese version of the post traumatic diagnostic scale for DSM-5 [up to one months]

      measure the post traumatic stress in burn patients,a cutoff score of 28 for identifying a probable PTSD diagnosis

    4. garmin_Vivosmart 3 [up to one months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05885321
    Other Study ID Numbers:
    • 202212108RINC
    First Posted:
    Jun 1, 2023
    Last Update Posted:
    Jun 1, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2023