The Efficacy of ICU Diary on Sleep, Fatigue and Stress
21. juni 2026 opdateret af: Sih-hua Chen, Taichung Tzu Chi Hospital
The Effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs
To create a constructive ICU diary and to comprehend the effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
142
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Not in USA
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Taichung, Not in USA, Taiwan, 427
- Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- caregivers who has ICU patients using ventilators for more than 48 hours
Exclusion Criteria:
- sleep disturbance history
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: interventional
ICU diary and stress relaxation and sleep hygiene booklet
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ICU diary
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Ingen indgriben: Control group
stress relaxation and sleep hygiene booklet
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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sleep disturbance
Tidsramme: baseline and one week later
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General Sleep disturbances Scale (GSDS) GSDS was used to measure sleep disturbances (Lee, 2007).
The GSDS is a 21-item self-report instrument that assesses sleep patterns during the previous week across seven domains: difficulty initiating sleep, mid-sleep awakenings, early awakenings, sleep quality, sleep quantity, daytime sleepiness, and use of substances to aid sleep (Lee, 1992).
Items are rated on an 8-point Likert scale ranging from 0 (never) to 7 (every day).
A mean item or subscale score ≥ 3 indicates sleep disturbances (Lee, 1992).
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baseline and one week later
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fatigue severity
Tidsramme: baseline and one week later
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7-item Lee's Fatigue Scale (LFS) Fatigue was assessed using the 7-item Lee Fatigue Scale (LFS) (Lee et al., 1991; Tsai et al., 2014).
Items are rated from 0 (not at all) to 10 (extremely), with higher scores indicating greater fatigue severity.
A mean score > 3.3 indicates clinically significant fatigue (Lee et al., 1991).
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baseline and one week later
|
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stress
Tidsramme: baseline and one week later
|
Impact of Event Scale-Revised (IES-R) Perceived stress was assessed using IES-R, which consists of 22 items across three subscales, including intrusion, avoidance, and hyperarousal symptoms related to a traumatic event (Weiss & Marmar, 1997; Wu & Chan, 2003).
Total scores range from 0 to 88, with higher scores indicating greater distress.
A total score ≥ 33 or a mean item score ≥ 1.5 has been suggested as indicative of a higher risk of PTSD (Creamer et al., 2003).
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baseline and one week later
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Coping
Tidsramme: baseline and one week later
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Brief Coping Orientation to Problems Experienced (Brief COPE) The Brief COPE was used to measure coping strategies, which is a 28-item self-report instrument designed to assess coping responses to stress (Carver, 1997; Su et al., 2015).
Items are rated on a 4-point Likert scale ranging from 1 (I have not been doing this at all) to 4 (I have been doing this a lot), with higher scores indicating more frequent use of a coping strategy.
Brief COPE scores were categorized into three dimensions, including active coping, dysfunctional coping, and distraction coping, based on a factor structure validated among Taiwanese caregivers of children with chronic illness (Tang et al., 2021).
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baseline and one week later
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Social Support
Tidsramme: Multidimensional Scale of Perceived Social Support (MSPSS) The MSPSS is a 12-item self-report instrument that assesses perceived support from three sources: family, friends, and significant others, with four items in each subscale (Chou, 2000; Zimet et
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Multidimensional Scale of Perceived Social Support (MSPSS) The MSPSS is a 12-item self-report instrument that assesses perceived support from three sources: family, friends, and significant others, with four items in each subscale (Chou, 2000; Zimet et
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. november 2023
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
26. november 2024
Først indsendt, der opfyldte QC-kriterier
3. juni 2026
Først opslået (Faktiske)
8. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC112-21
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