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

NCT06668285 | Not Yet Recruiting

• 1 other identifier: 101
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Family Centered Care; Comfort; Vital Sign Evaluation; Parent

Keywords

family centered care; parents presence; comfort; vital signs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• heart rate

  Baseline, and first minute of the visit and first/fifth minute after the visit

• saturation

  Baseline, and first minute of the visit and first/fifth minute after the visit

• respiratory rate

  Baseline, and first minute of the visit and first/fifth minute after the visit

• blood pressure

  Baseline, and first minute of the visit and first/fifth minute after the visit

Interventions

parental presence BEHAVIORAL

parental presence in PICU

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

0-3 years

You may qualify if:

• Being hospitalized in Behçet Uz Pediatric Intensive Care Unit

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Dr. Behcet Uz Children's Hospital: collaborator

Study Officials

• Esra Ardahan Akgül, PhD

  İzmir Katip Çelebi University

  STUDY CHAIR

Central Study Contacts

Esra Ardahan Akgül, PhD

CONTACT

+00905544318386; esraardahan90@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: April 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: July 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share