Effects of the Pediatric Intensive Care Unit Diary on Parents

September 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Event Scale-Revised, IES-R
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10/07/2026 168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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