- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07677527
Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units (VPTG-RCT)
Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units: A Randomized Controlled Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Emergency nurses regularly encounter critically ill, injured, and dying patients, exposing them to repeated indirect traumatic experiences. Such exposure can lead to vicarious trauma, emotional exhaustion, and psychological distress. However, exposure to trauma may also contribute to positive psychological changes referred to as vicarious post-traumatic growth.
This study evaluates the efficacy of a structured Vicarious Post-Traumatic Growth Intervention developed specifically for nurses working in emergency units. The intervention integrates psychoeducation, cognitive behavioral techniques, mindfulness practices, resilience enhancement strategies, emotional regulation skills, stress management techniques, and peer support activities.
A randomized controlled trial design will be employed. Eligible nurses will be randomly assigned to either an intervention group or a control group. Participants will complete baseline assessments before intervention implementation. Outcome measures will be reassessed immediately after completion of the intervention and during follow-up assessments.
Primary outcomes include reduction in vicarious trauma and enhancement of vicarious post-traumatic growth. Secondary outcomes include resilience, coping strategies, psychological well-being, and occupational functioning. Findings may contribute to the development of evidence-based psychological support programs for nurses working in high-stress healthcare settings.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: SEERAT FATIMA
- Telefonní číslo: +923066605577
- E-mail: seeratfatima554@gmail.com
Studijní místa
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Multan, Pákistán, 59070
- Nábor
- Nishtar Hospital, Burn Unit (NMH), Multan Institute of Cardiology (MIC), Bakhtawar Amin Hospital, Multan, Khawaja Fareed Social Security Hospital
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Kontakt:
- SEERAT FATIMA
- Telefonní číslo: 03066605577
- E-mail: seeratfatima554@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Registered nurses currently employed in emergency departments.
- Minimum six months of emergency department work experience.
- Able to read and understand English or Urdu.
- Willing to provide informed consent.
- Available to participate throughout intervention and follow-up assessments.
Exclusion Criteria:
- Current diagnosis of severe psychiatric disorder requiring intensive treatment.
- Current participation in trauma-focused psychotherapy.
- Cognitive impairment affecting study participation.
- Planned transfer from emergency unit during study period.
- Refusal to provide informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Vicarious Post-Traumatic Growth Intervention
Participants receive a structured psychoeducational intervention consisting of trauma education, cognitive behavioral techniques, mindfulness exercises, resilience-building activities, stress management training, emotional regulation skills, and peer support sessions.
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A structured psychoeducational and behavioral intervention designed to promote vicarious post-traumatic growth and reduce vicarious trauma among emergency nurses.
The intervention incorporates cognitive behavioral therapy (CBT) techniques, mindfulness practices, resilience-building exercises, psychoeducation regarding vicarious trauma, stress management strategies, reflective activities, and peer-support components.
The program is delivered in scheduled sessions over the intervention period and aims to enhance coping skills, psychological well-being, professional functioning, and post-traumatic growth.
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Žádný zásah: Routine Professional Support
Participants continue receiving routine institutional support and standard professional resources available within the hospital setting.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Vicarious Posttraumatic Growth Score
Časové okno: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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This outcome measures change in vicarious posttraumatic growth among emergency unit nurses exposed to the intervention. Vicarious posttraumatic growth will be assessed using the Vicarious Posttraumatic Growth Inventory (VPTGI; Deaton, 2020), a self-report questionnaire. The total score will be calculated by summing item responses. Higher scores indicate greater vicarious posttraumatic growth (better psychological outcome). |
Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Vicarious Trauma Score
Časové okno: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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This outcome measures vicarious trauma symptoms among emergency nurses.
The Vicarious Trauma Scale (VTS; Vrklevski & Franklin, 2008) will be used.
The total score is obtained by summing item responses.
Higher scores indicate greater vicarious trauma (worse psychological outcome).
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Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Change in Resilience Score
Časové okno: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Resilience will be assessed using the Brief Resilience Scale (BRS), which measures the ability to recover from stress.
Scores are calculated as the mean of all items.
Higher scores indicate greater resilience (better outcome).
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Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Change in Coping Strategies
Časové okno: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Coping strategies will be assessed using the CSI-SF, measuring both adaptive and maladaptive coping styles.
Scores will be reported as subscale and total scores.
Higher adaptive coping scores indicate better coping outcomes.
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Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Change in Psychological Well-being
Časové okno: Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Psychological well-being will be assessed using the 18-item Psychological Well-being Scale.
Total scores will be computed by summing item responses.
Higher scores indicate better psychological well-being.
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Baseline (Week 0), Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Personality Traits
Časové okno: Baseline only (Week 0)
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Personality traits (Big Five dimensions) will be assessed using the Ten-Item Personality Inventory (TIPI).
Scores will be calculated for each trait dimension.
This measure will be used as a baseline covariate and moderator, not as an intervention outcome.
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Baseline only (Week 0)
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Intervention Adherence
Časové okno: Throughout intervention period (Weeks 1-8)
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Measured as the percentage of attended intervention sessions (CBT, mindfulness, psychoeducation, peer support). Reported as percentage (%) of completed sessions per participant. |
Throughout intervention period (Weeks 1-8)
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Intervention Fidelity
Časové okno: During intervention delivery (Weeks 1-8)
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Assessed using a structured fidelity checklist completed by supervisors to ensure protocol adherence. Reported as percentage of protocol components delivered correctly. |
During intervention delivery (Weeks 1-8)
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Attrition Rate
Časové okno: Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Number and percentage of participants who drop out of the study at each assessment point.
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Post-intervention (Week 8), 3-month follow-up (Week 20), 6-month follow-up (Week 32)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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