Fatigue After Burn

May 11, 2026 updated by: Sara Enblom, Uppsala University Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Uppsala University Hospital, Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. ≥ 18 years;
  2. treated at the Burn unit at least 24 hours and
  3. managed Swedish verbally and in writing

Exclusion Criteria:

  1. any underlying disease that made it impossible to complete the questionnaires, or
  2. the patient chose to abstain the routine 12-month follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and 12 months post-burn.
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.
6 and 12 months post-burn.
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.
6 and 12 months post-burn.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 and 12 months post-burn.
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
6 and 12 months post-burn.
The Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 6 and 12 months post-burn.
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).
6 and 12 months post-burn.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2020

Primary Completion (Actual)

August 19, 2025

Study Completion (Actual)

August 19, 2025

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fatigue burn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Burn Injury

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe