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Not yet recruiting NCT06668285

The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU

Observational Family Centered Care Comfort Vital Sign Evaluation Parent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: parental presence.
Who it may be relevant to
Registry conditions: Family Centered Care, Comfort, Vital Sign Evaluation, Parent. Basic parameters: 0 years — 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study. The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day. Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.

Detailed description

There is a growing concern about psychological sequelae in children after hospitalization in the PICU. Despite the prevalence of adverse outcomes such as post-traumatic stress disorder, anxiety and behavioral problems in children after NICU admission, interventions to promote children's comfort have been limited. Children are physically and emotionally vulnerable and exposed to highly harmful environmental stimuli in the PICU. In a study by Johnston et al. in which mothers attempted to touch and talk to children during invasive procedures to reduce children's pain, children recovered faster and mothers experienced reduced anxiety, helplessness and an increased sense of purpose in caring for their children. Melnyk et al. examined the effect of a maternal coping intervention and found less anxiety in mothers and children. Despite these findings, the role of the parent when a child is hospitalized in the PICU is poorly defined. Parents describe the role change in the PICU as a tremendous stressor and report feeling helpless, anxious and fearful at the bedside. They suggest that comforting approaches that mimic home routines may alleviate these feelings and benefit their child.The study is planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.

The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.

Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study

Interventions

  • Behavioral parental presence
    parental presence in PICU

Primary outcome measures

  • comfort scale point [Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit]
Secondary outcome measures (4)
  • heart rate [Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit]
  • saturation [Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit]
  • respiratory rate [Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit]
  • blood pressure [Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit]

Eligibility criteria

Inclusion criteria

  • Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
  • Parent's volunteering to participate in the study Exclusion Criteria

1\. Any intervention by the child's parent that may affect the dependent variables (watching cartoons, listening to music, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06668285 · 101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗