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Fatigue After Burn

maanantai 11. toukokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

85

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Fatigue Severity Scale
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Hospital Anxiety and Depression Scale (HADS)
Aikaikkuna: 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)
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 19. toukokuuta 2020

Ensisijainen valmistuminen (Todellinen)

Tiistai 19. elokuuta 2025

Opintojen valmistuminen (Todellinen)

Tiistai 19. elokuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 11. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 11. toukokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 18. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 18. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 11. toukokuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

PÄÄTTÄMÄTÖN

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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