Clinical trial NCT06668285: The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU
Official title: The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Family Centered Care
Comfort
Vital Sign Evaluation
Parent
Keywords: family centered care
parents presence
comfort
vital signs
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Dr. Behcet Uz Children's Hospital
First posted: 2024-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 0-3 years

Brief summary: 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

Eligibility criteria: Inclusion Criteria

1. Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
2. 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.)

Primary outcomes:
measure: comfort scale point
timeFrame: Baseline, and first minute of the visit and first/fifth minute after the visit
Secondary outcomes:
measure: heart rate
timeFrame: Baseline, and first minute of the visit and first/fifth minute after the visit
measure: saturation
timeFrame: Baseline, and first minute of the visit and first/fifth minute after the visit
measure: respiratory rate
timeFrame: Baseline, and first minute of the visit and first/fifth minute after the visit
measure: blood pressure
timeFrame: Baseline, and first minute of the visit and first/fifth minute after the visit
Other outcomes:
Locations:
Study officials:
affiliation: İzmir Katip Çelebi University
name: Esra Ardahan Akgül, PhD
role: STUDY_CHAIR
References: