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Fatigue After Burn

11. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

85

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fatigue Severity Scale
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Mai 2020

Primärer Abschluss (Tatsächlich)

19. August 2025

Studienabschluss (Tatsächlich)

19. August 2025

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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