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Effectiveness of Stress Management Training in Reducing Caregiver Burden and Perceived Stress in ICU Families

4 settembre 2026 aggiornato da: Mutaz Fuad Ghleb Alradaydeh, Al-Balqa Applied University

Effectiveness of a Stress Management Training Program in Reducing Caregiver Burden and Perceived Stress Among Families of Long-Stay ICU Patients

This research helps to close an important gap in the provision of care to ICU families and introduces a structured and accessible psychological intervention to family caregivers of long-stay ICU patients. The findings are expected to contribute to the integration of stress management training in family-centered nursing practices and contribute to improved psychological well-being of the caregivers of families in intensive care settings.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Admission to intensive care unit (ICU) is a very stressful event to the patient and his family members. Family caregivers of critically ill patients are confronted with constant uncertainty, fear of negative outcomes of care, unfamiliar environments, and a minimal participation in care, which makes them extremely vulnerable to developing psychological distress (Checa-Checa et al., 2025). This distress is often made worse when going through long serving time in ICU, especially when the patients are not able to communicate and be taken part in the decision-making process.

Family caregivers play a central role during the ICU hospitalization in terms of offering emotional support, attending the decision-making process, and offering a constant presence at the bedside. These responsibilities are often associated with neglect of the physical as well as psychological requirements of the caregivers. Evidence from hospital and critical care settings suggests that caregivers are exposed to high levels of stress and of emotional exhaustion, sleep disturbances and disruption to daily functioning (Abuatiq et al., 2020; McIlvennan et al., 2021). Over time these stressors may yield caregiver burden (a multidimensional phenomenon which may involve physical, emotional, social and psychological strains).

High levels of caregiver burden and perceived stress have been documented among multiple different populations of caregivers, including caregivers of patients with chronic and life-threatening conditions. Studies involving either family caregivers of patients undergoing hemodialysis, living with heart failure or recovering from stroke all report moderate to severe caregiver burden with high levels of perceived stress and negative emotions outcomes (Shaykh et al., 2023; Khouban-Shargh et al., 2024; Liu et al., 2025). These findings have a very relevant application in ICU, where the level of care, uncertainty about prognosis and very long stay cause further jeopardy among caregivers.

Perceived stress represents people's appreciation of situations as unpredictable, uncontrollable, and overwhelming. Among caregivers in the family setting, the high perceived stress levels have been linked to poor preparedness for caregiving positions, emotional stress, and lessened ability to cope (McIlvennan et al., 2021). Stressors like awaiting results of test results, fearing patient deterioration, sleep deprivation, monetary concerns, and lack of information access are common in ICU and hospital settings (Abuatiq et al, 2020; Krampe et al, 2021) according to caregivers.

Stress management interventions attempt to increase adaptive coping by increasing the ability to manage stress through better awareness of stress, the way we think about things, the way we manage emotions, and how well we are able to solve problems. Evidence from caring populations suggest that the implementation of structured stress management training programs was able to lower the burden on caregivers and perceived stress and also increase psychological well-being (Shaykh et al., 2023; Liu et al., 2025). In the critical care, interventions led by nurses and psychosocial healthcare have been linked to lessened psychological distress and better emotional outcomes among family members (Checa-Checa et al., 2025; Watland et al., 2025). However, many of the ICU interventions focus mainly on information provision and decision-making support, and may not place much emphasis on structured stress management training.

Despite the growing recognition of family-centered care within ICUs, a discrepancy exists with respect to the number of potential interventional research based specifically on issues of burden and perceived stress to family members of long-stay ICU patients. Evaluation of the effectiveness of a structured stress management training program in this population is, therefore, warranted in order to support the well-being of carers and to improve holistic and family-centred nursing care.

Aim of the Study To assess the effectiveness of a stress management training program in lowering caregiver burden, and perceived stress in family members of patients admitted to the ICU for over 10 days.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Aged 18 years or older.
  • Identified as the primary caregiver or main family companion of a patient admitted to the ICU.
  • The patient has had an ICU stay of more than 10 consecutive days.
  • Able to communicate verbally and complete the study questionnaires.
  • Have access to a smartphone, tablet, computer, or other digital device with internet access to participate in the training sessions.
  • Willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

  • A history of a psychiatric disorder that substantially impairs their ability to understand the study procedures, communicate effectively, or complete the study questionnaires reliably.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: interventional group
Stress Management Training Program

structured program of stress management training, including:

  • Education regarding stress, burden on caregivers and emotional response during ICU settings.
  • Identification of personal stressors of prolonged ICU hospitalization.
  • Cognitive techniques for recognizing and changing the negative or unhelpful thought patterns.
  • Problem-solving skills to manage challenges of care effective.
Nessun intervento: control group
no interventions

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Perceived Stress Score
Lasso di tempo: 6 weeks
Perceived stress will be assessed using the 14-item Perceived Stress Scale (PSS-14). The PSS assesses the level of perceived stress experienced over the previous month. The PSS is available in three versions, including the PSS-14. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). After reverse-scoring the positively worded items, the item scores are summed to produce a total score ranging from 0 to 56. Higher total scores indicate greater perceived stress. The unit of measure is the total PSS-14 score (0-56).
6 weeks
Caregiver Burden as Measured by the 12-Item Zarit Burden Interview (ZBI-12)
Lasso di tempo: 6 weeks
Caregiver burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12). The ZBI-12 consists of 12 items rated on a 5-point Likert scale from 0 (never) to 4 (nearly always), with a total score ranging from 0 to 48. Higher total scores indicate greater perceived caregiver burden. The unit of measure is the total ZBI-12 score (0-48).
6 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 settembre 2026

Completamento primario (Stimato)

20 novembre 2026

Completamento dello studio (Stimato)

20 dicembre 2026

Date di iscrizione allo studio

Primo inviato

25 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 60/5/2025/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .