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Completed

NCT Number: NCT05885321

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the Chinese version of the 5D itch scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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