Burn InjuryNCT07592845
Fatigue After Burn
An observational study of Burn Injury, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The goal of this observational, prospective cohort study is to learn more about fatigue after burn injury and how it associates with daily activities, health-related quality of life, and return to work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- 19 May 2020to 19 Aug 2025
- How long will I take part?
- 12 Months
- 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: All consecutive patients scheduled for follow-up at the Burn center's outpatient clinic in Uppsala 6 ±3 months post burn were asked to participate in the study.
Who may be able to join
- ≥ 18 years;
- treated at the Burn unit at least 24 hours and
- managed Swedish verbally and in writing
Who cannot join
- any underlying disease that made it impossible to complete the questionnaires, or
- the patient chose to abstain the routine 12-month follow-up.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala University Hospital, Burn Center
Uppsala, Uppsala County, 75185
About this study
Official title: Fatigue After Burn - Associations With Daily Activities, Health-related Quality of Life, and Return to Work
The goal of this observational, prospective cohort study is to learn more about fatigue after burn injury and how it associates with daily activities, health-related quality of life, and return to work. The study is based on data from adult patients who come for follow-up at the Burn Centre's outpatient clinic at Uppsala university hospital 6- and 12 months post-burn.
Patients who come for follow-up are routinely asked to fill out several questionnaires to detect any problems that might have occurred due to the burn injury. Apart from ordinary assessments the study participants were asked to fill out three additional questionnaires. Data from questionnaires together with patient characteristics will be analysed and compiled and presented in a scientific article.
Read the detailed description
Physical function and daily activities are often affected after a burn injury. Previous research show complications that significantly affect the recovery, such as pain, muscle weakness, scar contractures, hypertrophic scarring, psychosocial problems, and fatigue. The symptoms decrease with time but 26 % still experience fatigue one year post burn and some patients never return to the same level as before the burn injury.
The association between fatigue and different variables has been investigated when it comes to burn patients. Various studies observe a connection between major burns (≥20 % TBSA, the Total Body Surface Area of burnt skin in %) and gender. Associations between fatigue and age, burn depth, and cause of injury show varying/contradictory results. Associations between fatigue and depression have also been observed since the symptoms of fatigue and depression are similar and sometimes overlapping. Edwards et al. show a significant correlation between anxiety/depression and fatigue, and depression one year post burn is reported in 10 - 23 % of the patients.
To increase the knowledge about rehabilitation after burn injury and how fatigue affects daily life post burn the present work aims to investigate to what extent fatigue is a problem among Swedish burn victims. International research is available, but more knowledge is needed to increase the opportunity to help and guide patients towards a more meaningful and manageable daily life.
Objectives Primary objective: to investigate the association between fatigue and
- activity performance,
- health-related quality of life and
- return to work at 6 months, and 12 months post-burn
Secondary objectives:
- To examine whether fatigue is associated with anxiety and depression scores
- To determine if subjective scar assessment is associated with fatigue levels
- To evaluate if intubation during initial treatment is associated with subsequent fatigue
This is a prospective cohort study based on data from patients who suffered a burn injury and were admitted as inpatients to the Burn Centre at Uppsala University Hospital between May 2020 and August 2025. All patients who came for follow-up 6 months after their burn injury were asked to participate, if they fulfilled the inclusion criteria and no exclusion criteria.
Eighty-five patients were enrolled in this study. The number based on a power calculation made in SPSS for Windows, with a desired power of 0.9, a Spearman correlation parameter of 0.4 and a statistical significance level of 0.05. The variance was estimated by the method proposed by Bonett and Wright and the number of patients recommended was 67, at a minimum. All the included patients' have given their written and informed consent.
Outcome definitions The patients are routinely asked to fill out several questionnaires to detect any problems that might have occurred after the burn injury. Apart from ordinary routine assessments the study participants are asked to fill out three additional questionnaires at each follow-up visit. The questionnaires (described in another section) will be handed out to the participants at two time-points, at the 6- and 12-months follow-up visits.
If the patient cannot fill out the questionnaires in connection with the follow-up visit, they may bring them home and return the completed questionnaires in a return envelope as soon as possible after the visit. Should the patient cancel the 12-month follow-up visit they will be contacted by phone and asked if they might consider filling out the questionnaires if they are sent home by mail.
Data analysis Data will be analysed collectively when all the included patients have had their last follow-up at 12 months and all the data have been registered. Data will be analysed using IBM SPSS Statistics for Windows (version 23, IBM Corp, Armonk, NY, USA). The threshold for statistical significance is p<0.05. All confidence intervals presented will be 95%.
Data will be analysed and compared in the following sub-groups:
- Without fatigue, FSS <4, with fatigue, FSS ≥4, with results from each time point.
- %TBSA, minor burns <20% TBSA/major burns ≥20% TBSA. Data will be presented as mean, range, standard deviation, and confidence interval. To assess changes over time, between the two time points, 6- and 12-months post-burn, the results will be analysed using dependent t-test for continuous data, and Wilcoxon signed-rank test for nominal or ordinal data.
A Generalized Linear Mixed Model analysis (GLMM) will be performed to assess the associations between FSS and other variables: EQ VAS, POSAS, HADS anxiety, HADS depression, TBSA %, and PS-ADL.
Patient characteristics such as age, gender, marital status, % total body surface area (%TBSA) burned, length of stay (LOS), surgery, and intubation will be collected from the patients' medical records and presented in a table with demographics, using descriptive statistics; means, range, percentage, and standard deviation, where applicable.
- Conditions
- Burn Injury
- Keywords
- Burn injury, Fatigue, Activities of daily living, Health-related quality of life, Return to work, Occupational therapy
- Medical subject headings
- Burns, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Fatigue Severity Scale (FSS) is a uni-dimensional self-assessment scale that measures the impact of fatigue on daily activities. The questionnaire includes nine statements on a seven-point Likert rating scale, from 1 ("completely disagree") to 7 ("completely agree"). Scores ≥ 4 indicate fatigue.
Measured: 6 and 12 months post-burn.
Performance and Satisfaction in Activities of Daily Living (PS-ADL)
PS-ADL evaluates activity performance. The patient assesses 39 daily activities, the difficulty with which the activity is performed and how satisfied the patient is with how the activity is performed. The total score ranges from 0 to 3, the higher the score the more problem with activity performance.
Measured: 6 and 12 months post-burn.
Return to work
Return to work was assessed through a couple of questions regarding current employment/studies/retirement alternatively sick leave, including the patient's own experience of the cause for it. The data presented in this study includes a) back to work/studies on part or full time, b) on sick leave or c) retired.
Measured: 6 and 12 months post-burn.
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
HADS a valid self-assessment scale evaluating anxiety and depression. The HADS involves fourteen statements, seven relate to anxiety and seven to depression. The scores sum up to 21 in each subscale, ≥11 means that depression/anxiety is likely present. The assessment was used in this study as a screening of the patient's mental well-being since the symptoms of fatigue and anxiety/depression sometimes overlap
Measured: 6 and 12 months post-burn.
The Patient and Observer Scar Assessment Scale (POSAS)
POSAS consists of two scales: the observer scale and the patient scale. In this study only the patient scale is included. The patient scale consists of six items (pain, itch, colour, stiffness, thickness, irregularity) which sum up to a total score. The patient is also asked to give an overall opinion. Each item is rated on a 10-point scale, ranging from 1 (no, not at all/no, as normal skin) to 10 (yes, very much/yes, very different).
Measured: 6 and 12 months post-burn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start19 May 2020
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Enblom, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592845
- Sponsor's protocol ID
- Fatigue burn
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Should another researcher need access to data from this study to perform another study in the near future, it will be considered, provided that the neccessary permits and ethical approval is obtained.
Publications
Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.
PubMed 18020941Gabbe BJ, Cleland H, Watterson D, Schrale R, McRae S, Taggart S, Darton A, Wood F, Edgar DW; BRANZ Adult Long Term Outcomes pilot project participating sites and working party. Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project. Burns. 2016 Dec;42(8):1652-1661. doi: 10.1016/j.burns.2016.08.036. Epub 2016 Oct 27.
PubMed 28341091Thibaut A, Shie VL, Ryan CM, Zafonte R, Ohrtman EA, Schneider JC, Fregni F. A review of burn symptoms and potential novel neural targets for non-invasive brain stimulation for treatment of burn sequelae. Burns. 2021 May;47(3):525-537. doi: 10.1016/j.burns.2020.06.005. Epub 2020 Jun 20.
PubMed 33293156Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.
PubMed 16554686Simko LC, Espinoza LF, McMullen K, Herndon DN, Suman O, Fauerbach JA, Kowalske K, Wiechman S, Kazis LE, Ryan CM, Schneider JC. Fatigue Following Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2018 Apr 20;39(3):450-456. doi: 10.1097/BCR.0000000000000625.
PubMed 28877130Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Oster C, Willebrand M, Dyster-Aas J, Kildal M, Ekselius L. Validation of the EQ-5D questionnaire in burn injured adults. Burns. 2009 Aug;35(5):723-32. doi: 10.1016/j.burns.2008.11.007. Epub 2009 Mar 17.
PubMed 19297100Archenholtz B, Dellhag B. Validity and reliability of the instrument Performance and Satisfaction in Activities of Daily Living (PS-ADL) and its clinical applicability to adults with rheumatoid arthritis. Scand J Occup Ther. 2008 Mar;15(1):13-22. doi: 10.1080/11038120701223165.
PubMed 17852967Rossi D, Galant LH, Marroni CA. PSYCHOMETRIC PROPERTY OF FATIGUE SEVERITY SCALE AND CORRELATION WITH DEPRESSION AND QUALITY OF LIFE IN CIRRHOTICS. Arq Gastroenterol. 2017 Dec;54(4):344-348. doi: 10.1590/S0004-2803.201700000-85. Epub 2017 Oct 2.
PubMed 28977117Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
PubMed 23791482Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Machado MO, Kang NC, Tai F, Sambhi RDS, Berk M, Carvalho AF, Chada LP, Merola JF, Piguet V, Alavi A. Measuring fatigue: a meta-review. Int J Dermatol. 2021 Sep;60(9):1053-1069. doi: 10.1111/ijd.15341. Epub 2020 Dec 10.
PubMed 33301180
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue After Burn - Associations With Daily Activities, Health-related Quality of Life, and Return to Work
- ClinicalTrials.gov ID
- NCT07592845
- Acronym / sponsor ID
- Fatigue burn
- Conditions
- Burn Injury
- Keywords
- Burn injury, Fatigue, Activities of daily living, Health-related quality of life, Return to work, Occupational therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 18 May 2026 (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.
The goal of this observational, prospective cohort study is to learn more about fatigue after burn injury and how it associates with daily activities, health-related quality of life, and return to work. The study is based on data from adult patients who come for follow-up at the Burn Centre's outpatient clinic at Uppsala university hospital 6- and 12 months post-burn.
Patients who come for follow-up are routinely asked to fill out several questionnaires to detect any problems that might have occurred due to the burn injury. Apart from ordinary assessments the study participants were asked to fill out three additional questionnaires. Data from questionnaires together with patient characteristics will be analysed and compiled and presented in a scientific article.
Detailed description
Physical function and daily activities are often affected after a burn injury. Previous research show complications that significantly affect the recovery, such as pain, muscle weakness, scar contractures, hypertrophic scarring, psychosocial problems, and fatigue. The symptoms decrease with time but 26 % still experience fatigue one year post burn and some patients never return to the same level as before the burn injury.
The association between fatigue and different variables has been investigated when it comes to burn patients. Various studies observe a connection between major burns (≥20 % TBSA, the Total Body Surface Area of burnt skin in %) and gender. Associations between fatigue and age, burn depth, and cause of injury show varying/contradictory results. Associations between fatigue and depression have also been observed since the symptoms of fatigue and depression are similar and sometimes overlapping. Edwards et al. show a significant correlation between anxiety/depression and fatigue, and depression one year post burn is reported in 10 - 23 % of the patients.
To increase the knowledge about rehabilitation after burn injury and how fatigue affects daily life post burn the present work aims to investigate to what extent fatigue is a problem among Swedish burn victims. International research is available, but more knowledge is needed to increase the opportunity to help and guide patients towards a more meaningful and manageable daily life.
Objectives Primary objective: to investigate the association between fatigue and
- activity performance,
- health-related quality of life and
- return to work at 6 months, and 12 months post-burn
Secondary objectives:
- To examine whether fatigue is associated with anxiety and depression scores
- To determine if subjective scar assessment is associated with fatigue levels
- To evaluate if intubation during initial treatment is associated with subsequent fatigue
This is a prospective cohort study based on data from patients who suffered a burn injury and were admitted as inpatients to the Burn Centre at Uppsala University Hospital between May 2020 and August 2025. All patients who came for follow-up 6 months after their burn injury were asked to participate, if they fulfilled the inclusion criteria and no exclusion criteria.
Eighty-five patients were enrolled in this study. The number based on a power calculation made in SPSS for Windows, with a desired power of 0.9, a Spearman correlation parameter of 0.4 and a statistical significance level of 0.05. The variance was estimated by the method proposed by Bonett and Wright and the number of patients recommended was 67, at a minimum. All the included patients' have given their written and informed consent.
Outcome definitions The patients are routinely asked to fill out several questionnaires to detect any problems that might have occurred after the burn injury. Apart from ordinary routine assessments the study participants are asked to fill out three additional questionnaires at each follow-up visit. The questionnaires (described in another section) will be handed out to the participants at two time-points, at the 6- and 12-months follow-up visits.
If the patient cannot fill out the questionnaires in connection with the follow-up visit, they may bring them home and return the completed questionnaires in a return envelope as soon as possible after the visit. Should the patient cancel the 12-month follow-up visit they will be contacted by phone and asked if they might consider filling out the questionnaires if they are sent home by mail.
Data analysis Data will be analysed collectively when all the included patients have had their last follow-up at 12 months and all the data have been registered. Data will be analysed using IBM SPSS Statistics for Windows (version 23, IBM Corp, Armonk, NY, USA). The threshold for statistical significance is p<0.05. All confidence intervals presented will be 95%.
Data will be analysed and compared in the following sub-groups:
- Without fatigue, FSS <4, with fatigue, FSS ≥4, with results from each time point.
- %TBSA, minor burns <20% TBSA/major burns ≥20% TBSA. Data will be presented as mean, range, standard deviation, and confidence interval. To assess changes over time, between the two time points, 6- and 12-months post-burn, the results will be analysed using dependent t-test for continuous data, and Wilcoxon signed-rank test for nominal or ordinal data.
A Generalized Linear Mixed Model analysis (GLMM) will be performed to assess the associations between FSS and other variables: EQ VAS, POSAS, HADS anxiety, HADS depression, TBSA %, and PS-ADL.
Patient characteristics such as age, gender, marital status, % total body surface area (%TBSA) burned, length of stay (LOS), surgery, and intubation will be collected from the patients' medical records and presented in a table with demographics, using descriptive statistics; means, range, percentage, and standard deviation, where applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients scheduled for follow-up at the Burn center's outpatient clinic in Uppsala 6 ±3 months post burn were asked to participate in the study.
Key inclusion criteria (3 listed)
- ≥ 18 years;
- treated at the Burn unit at least 24 hours and
- managed Swedish verbally and in writing
Key exclusion criteria (2 listed)
- any underlying disease that made it impossible to complete the questionnaires, or
- the patient chose to abstain the routine 12-month follow-up.
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
Fatigue Severity Scale
Time frame: 6 and 12 months post-burn.
Fatigue Severity Scale (FSS) is a uni-dimensional self-assessment scale that measures the impact of fatigue on daily activities. The questionnaire includes nine statements on a seven-point Likert rating scale, from 1 ("completely disagree") to 7 ("completely agree"). Scores ≥ 4 indicate fatigue.
Performance and Satisfaction in Activities of Daily Living (PS-ADL)
Time frame: 6 and 12 months post-burn.
PS-ADL evaluates activity performance. The patient assesses 39 daily activities, the difficulty with which the activity is performed and how satisfied the patient is with how the activity is performed. The total score ranges from 0 to 3, the higher the score the more problem with activity performance.
Return to work
Time frame: 6 and 12 months post-burn.
Return to work was assessed through a couple of questions regarding current employment/studies/retirement alternatively sick leave, including the patient's own experience of the cause for it. The data presented in this study includes a) back to work/studies on part or full time, b) on sick leave or c) retired.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 and 12 months post-burn.
The Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 6 and 12 months post-burn.
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 18 May 2026.
- Results publication: PubMed 18020941Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.
- Results publication: PubMed 28341091Gabbe BJ, Cleland H, Watterson D, Schrale R, McRae S, Taggart S, Darton A, Wood F, Edgar DW; BRANZ Adult Long Term Outcomes pilot project participating sites and working party. Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project. Burns. 2016 Dec;42(8):1652-1661. doi: 10.1016/j.burns.2016.08.036. Epub 2016 Oct 27.
- Results publication: PubMed 33293156Thibaut A, Shie VL, Ryan CM, Zafonte R, Ohrtman EA, Schneider JC, Fregni F. A review of burn symptoms and potential novel neural targets for non-invasive brain stimulation for treatment of burn sequelae. Burns. 2021 May;47(3):525-537. doi: 10.1016/j.burns.2020.06.005. Epub 2020 Jun 20.
- Results publication: PubMed 16554686Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.
- Results publication: PubMed 28877130Simko LC, Espinoza LF, McMullen K, Herndon DN, Suman O, Fauerbach JA, Kowalske K, Wiechman S, Kazis LE, Ryan CM, Schneider JC. Fatigue Following Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2018 Apr 20;39(3):450-456. doi: 10.1097/BCR.0000000000000625.
- Results publication: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Results publication: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Results publication: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Results publication: PubMed 19297100Oster C, Willebrand M, Dyster-Aas J, Kildal M, Ekselius L. Validation of the EQ-5D questionnaire in burn injured adults. Burns. 2009 Aug;35(5):723-32. doi: 10.1016/j.burns.2008.11.007. Epub 2009 Mar 17.
- Results publication: PubMed 17852967Archenholtz B, Dellhag B. Validity and reliability of the instrument Performance and Satisfaction in Activities of Daily Living (PS-ADL) and its clinical applicability to adults with rheumatoid arthritis. Scand J Occup Ther. 2008 Mar;15(1):13-22. doi: 10.1080/11038120701223165.
- Results publication: PubMed 28977117Rossi D, Galant LH, Marroni CA. PSYCHOMETRIC PROPERTY OF FATIGUE SEVERITY SCALE AND CORRELATION WITH DEPRESSION AND QUALITY OF LIFE IN CIRRHOTICS. Arq Gastroenterol. 2017 Dec;54(4):344-348. doi: 10.1590/S0004-2803.201700000-85. Epub 2017 Oct 2.
- Results publication: PubMed 23791482Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
- European Practice guidelines for Burn CareLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Should another researcher need access to data from this study to perform another study in the near future, it will be considered, provided that the neccessary permits and ethical approval is obtained.
Related trials for Burn Injury
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
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 Burn Injury, run by Uppsala University Hospital at 1 site in Sweden.
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 3 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 18 May 2026. 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 Sweden. 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?
Fatigue Severity Scale (time frame: 6 and 12 months post-burn.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07592845, which also lists 14 linked publications.
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 18 May 2026.