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

NCT ID: NCT06668285

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-07-31

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

Conditions

Family Centered Care; Comfort; Vital Sign Evaluation; Parent

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

parental presence

parental presence in PICU

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Being hospitalized in Behçet Uz Pediatric Intensive Care Unit

Exclusion Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

ESRA ARDAHAN AKGUL

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra Ardahan Akgül, PhD

Role: STUDY_CHAIR

İzmir Katip Çelebi University

Central Contacts

Esra Ardahan Akgül, PhD

Role: CONTACT

esraardahan90@gmail.com

+00905544318386

Other Identifiers

101

Identifier Type: -

Identifier Source: org_study_id