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Effects of the Pediatric Intensive Care Unit Diary on Parents

2. september 2026 oppdatert av: Emel Yürük, Cukurova University

The Effect of a Pediatric Intensive Care Unit Diary on Traumatic Stress, Anxiety, and Satisfaction With Care in Parents: A Randomized Controlled Trial

Pediatric intensive care unit (PICU) admission is a highly stressful and potentially traumatic experience for parents, who may experience anxiety, uncertainty, helplessness, and post-traumatic stress symptoms that can persist after discharge. PICU diaries have emerged as a family-centered intervention to help parents understand and reconstruct the intensive care experience, reduce memory gaps, facilitate emotional expression, and strengthen communication with healthcare professionals. Previous studies suggest that PICU diaries are feasible, acceptable, and potentially effective in reducing psychological distress and improving family experiences. However, randomized controlled studies evaluating their effects on parental traumatic stress, anxiety, and satisfaction with care remain limited. Moreover, no experimental study evaluating a structured PICU diary intervention in Türkiye has been identified. Therefore, evaluating the effects of PICU diaries on parental psychological outcomes and satisfaction with care is warranted.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Pediatric intensive care units (PICUs) provide advanced monitoring and treatment for children with life-threatening acute or chronic health conditions. A child's admission to the PICU can be a highly stressful and potentially traumatic experience not only for the child but also for parents and the entire family. During this period, parents may experience intense anxiety, uncertainty, fear, helplessness, and loss of control, and these psychological effects may persist even after discharge. These long-term consequences are increasingly recognized within the concept of Post-Intensive Care Syndrome-Family (PICS-F), which encompasses anxiety, depression, post-traumatic stress symptoms, and impaired social functioning among family members following an intensive care experience.

Family-centered care is a fundamental component of high-quality pediatric intensive care and emphasizes parental participation, collaboration with healthcare professionals, effective communication, and meeting families' informational and psychosocial needs. Within this framework, PICU diaries have emerged as an innovative intervention to support children and their families throughout the intensive care experience. PICU diaries are structured records in which healthcare professionals and family members document significant events, treatments, clinical developments, and personal or family messages during the child's PICU stay. These diaries are intended to facilitate understanding and reconstruction of the intensive care experience, reduce memory gaps, promote emotional expression, and help families make sense of potentially traumatic events.

Previous studies have demonstrated that PICU diaries are feasible and acceptable to families and may strengthen communication between parents and healthcare professionals, reduce uncertainty, facilitate parental involvement in care, and help parents process their child's intensive care journey. Recent evidence also suggests that diary interventions may contribute to reductions in parental anxiety and post-traumatic stress symptoms. However, randomized controlled studies evaluating the effects of PICU diaries on parental psychological outcomes remain limited. In particular, evidence regarding their effects on traumatic stress, anxiety, and satisfaction with care is insufficient. Furthermore, no experimental study evaluating the effectiveness of a structured PICU diary intervention in Türkiye has been identified.

This randomized controlled experimental study was designed to examine the effects of a structured intensive care diary implemented in the pediatric intensive care unit on parents' levels of traumatic stress, anxiety, and satisfaction with care.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

Deltakelseskriterier

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Beskrivelse

Inclusion Criteria:

  • Having a child aged 0-18 years
  • The child is expected to stay in intensive care for ≥72 hours
  • One or both parents must be able to read and write Turkish
  • Voluntary participation

Exclusion Criteria:

  • Child's death within the first 24 hours
  • Parent's history of serious psychiatric diagnosis
  • Previous PICU experience with the same child

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: No Intervention: GROUP WITH STANDARD CARE AND TREATMENT
Participants in the control group will continue to receive routine care and information provided in the pediatric intensive care unit. Parents in this group will not receive the intensive care diary intervention.
Eksperimentell: Experimental Group: Structured Pediatric Intensive Care Unit Diary (PICU Diary) Intervention

Participants in the experimental group will receive the structured Pediatric Intensive Care Unit Diary (PICU Diary) intervention in addition to routine intensive care. The diary intervention will be initiated within the first 48 hours following the child's admission to the PICU and will continue throughout the PICU stay.

A standardized intensive care diary developed by the researcher will be created for each child. The diary will be used to chronologically document events related to the child's intensive care experience by parents, nurses, physicians, and other healthcare professionals, with the aim of reducing parents' uncertainty, anxiety, and traumatic stress symptoms.

The diary will include nursing entries, parental messages, positive developments regarding the child's clinical progress, and photographs added with the family's consent.
Atferdsmessig: Pediatric Intensive Care Unit Diary (PICU Diary)
The PICU diary will include nursing entries, parental messages, positive clinical developments, and photographs. Nurses will document the child's clinical condition, treatments, significant events, and progress using clear and family-friendly language. Parents will be encouraged to write messages expressing their feelings, thoughts, and support for their child. Positive clinical milestones, such as reduced ventilatory support, initiation or advancement of feeding, and mobilization, will also be recorded. With written parental consent, photographs may be added once or twice a week depending on the child's clinical condition. Before implementation, the PICU team will receive standardized training on the purpose of the diary, documentation criteria, and their roles in diary writing. All caregivers will be invited to contribute to the diary, and the intervention will be implemented consistently across all participants.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact of Event Scale-Revised, IES-R
Tidsramme: 15 days after discharge
The Impact of Event Scale-Revised (IES-R) will be used to assess post-traumatic stress symptoms related to the pediatric intensive care experience among parents. Developed by Weiss and Marmar (1996), the IES-R consists of 22 items across three subscales: intrusion, avoidance, and hyperarousal. Each item is rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater post-traumatic stress symptoms. In the original study, Cronbach's alpha coefficients ranged from 0.87 to 0.92 for intrusion, 0.84 to 0.86 for avoidance, and 0.79 to 0.90 for hyperarousal. The Turkish validity and reliability study was conducted by Çorapçıoğlu et al. (2006), reporting a Cronbach's alpha coefficient of 0.94 for the total scale and demonstrating high validity and reliability in assessing post-traumatic stress symptoms.
15 days after discharge
State-Trait Anxiety Inventory, STAI
Tidsramme: initially at discharge 15 days after discharge
The State-Trait Anxiety Inventory (STAI), developed by Spielberger, Gorsuch, and Lushene (1970), will be used to assess parents' state and trait anxiety levels. The STAI consists of two 20-item subscales, the State Anxiety and Trait Anxiety subscales, with higher scores indicating higher levels of anxiety. The Turkish validity and reliability study was conducted by Öner and Le Compte (1985). The internal consistency coefficients ranged from 0.83 to 0.87 for the State Anxiety subscale and from 0.94 to 0.96 for the Trait Anxiety subscale, demonstrating that the Turkish version is a valid and reliable instrument.
initially at discharge 15 days after discharge
EMPATHIC-30
Tidsramme: at discharge 15 days after discharge
The EMpowerment of PArents in THe Intensive Care-30 (EMPATHIC-30) scale will be used to assess parents' satisfaction with care provided in the pediatric intensive care unit. Developed by Latour et al. (2011), the EMPATHIC-30 is a 30-item instrument comprising five domains: Information, Care and Treatment, Organization, Parent Participation, and Professional Attitude. Items are rated on a six-point Likert scale, with higher scores indicating greater parental satisfaction with care. In the original study, Cronbach's alpha coefficients for the subscales ranged from 0.73 to 0.93, demonstrating good internal consistency. The Turkish validity and reliability study was conducted by Tiryaki et al. (2020), with a Cronbach's alpha coefficient of 0.95 for the total scale and coefficients ranging from 0.80 to 0.92 for the subscales. The intraclass correlation coefficient (ICC) for test-retest reliability was 0.998, indicating that the Turkish version is a highly valid and reliable instrument.
at discharge 15 days after discharge

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Sponsor

Cukurova University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

2. september 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

8. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

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Nøkkelord

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  • 10/07/2026 168

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