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Effects of the Pediatric Intensive Care Unit Diary on Parents

2 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Impact of Event Scale-Revised, IES-R
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cukurova University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

2 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

8 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 10/07/2026 168

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