BurnsNCT05885321
Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients
An observational study of Burns and Scar Pruritus, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Scar Pruritus, Post Traumatic Stress Disorder
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with first-degree burns
- Non-traumatic electrical burns
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Burns, Scar Pruritus, Post Traumatic Stress Disorder, Perceived Stress
- Medical subject headings
- Burns, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: up to one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start6 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885321
- Sponsor's protocol ID
- 202212108RINC
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients
- ClinicalTrials.gov ID
- NCT05885321
- Acronym / sponsor ID
- 202212108RINC
- Conditions
- Burns, Scar Pruritus, Post Traumatic Stress Disorder, Perceived Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with first-degree burns
- Non-traumatic electrical burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Scar Pruritus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Chinese version of the 5D itch scale (time frame: up to one months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.