- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: YUN SHAN CHOU
- Phone Number: 886-972020895
- Email: sam573420028184@gmail.com
Study Locations
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
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Contact:
- YUN SHAN CHOU
- Phone Number: +886-972020895
- Email: sam573420028184@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Patients with hypertrophic scars 3 months 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
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Chinese version of the 5D itch scale
Time Frame: up to one months
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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).
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up to one months
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Chinese version of Perceived Stress Scale
Time Frame: up to one months
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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
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up to one months
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Chinese version of the post traumatic diagnostic scale for DSM-5
Time Frame: up to one months
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measure the post traumatic stress in burn patients,a cutoff score of 28 for identifying a probable PTSD diagnosis
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up to one months
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garmin_Vivosmart 3
Time Frame: up to one months
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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.
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up to one months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202212108RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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