An observational study in Burns, Scar Pruritus and Post Traumatic Stress Disorder, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by National Taiwan University Hospital · Observational
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.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 43 observational studies indexed under Pruritus.
Browse Pruritus studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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).
Time frame: up to one months
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
Time frame: up to one months
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
Time frame: up to one months
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.
Time frame: up to one months
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital