About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Child's death within the first 24 hours
Parent's history of serious psychiatric diagnosis
Previous PICU experience with the same child
Trial design
Parallel
Treatments tested in this trial
Pediatric Intensive Care Unit Diary (PICU Diary)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Impact of Event Scale-Revised, IES-R
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.
State-Trait Anxiety Inventory, STAI
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.
EMPATHIC-30
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: