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Effects of the Pediatric Intensive Care Unit Diary on Parents

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07807267
Enrollment
100
Registered
2026-09-08
Start date
2026-10-01
Completion date
2027-06-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, PICU

Keywords

Pediatric Intensive Care Units, Parents, Post-Traumatic Anxiety, Diaries

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPediatric 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.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of Event Scale-Revised, IES-R15 days after dischargeThe 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.
State-Trait Anxiety Inventory, STAIinitially at discharge 15 days after dischargeThe 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.
EMPATHIC-30at discharge 15 days after dischargeThe 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTEmel YÜRÜK, PHD
emelyurukbal@gmail.com+905387115176
CONTACTAslıhan HACISALİHOĞLU, MSC
asli.han.hem@gmail.com+905342612377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026