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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parent; Comfort; Family Centered Care; Vital Sign Evaluation
• Intervention / Treatment: Behavioral: parental presence

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

• Study Type: Observational
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Ardahan Akgül, PhD; Phone Number: +00905544318386; Email: esraardahan90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

0-3 years

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sham Comparator: Control; The group in which the routine functioning of the clinic is applied and caregivers are not admitted to the recovery room	Other: no intervention; no intervention
Experimental: family group; The group in which caregivers are admitted to the recovery room	Behavioral: parental presence; parental presence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comfort scale point	before, during and after the 1st and 5th minute of the visit	Baseline, and first minute of the visit and first/fifth minute after the visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	heart rate will be measured by Braun YK-81CEU	Baseline, and first minute of the visit and first/fifth minute after the visit
saturation	saturation will be measured by Braun YK-81CEU	Baseline, and first minute of the visit and first/fifth minute after the visit
respiratory rate	respiratory rate will be measured by Braun YK-81CEU	Baseline, and first minute of the visit and first/fifth minute after the visit
blood pressure	blood pressure will be measured by Nimo HS-20C Aneroid	Baseline, and first minute of the visit and first/fifth minute after the visit

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Collaborators: Dr. Behcet Uz Children's Hospital
• Investigators: Study Chair: Esra Ardahan Akgül, PhD, Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: comfort; vital signs; family centered care; parents presence
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

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