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NCT Number: NCT06668285

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.

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Key information

Age range

0 year–3 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
  • Parent's volunteering to participate in the study Exclusion Criteria
  • Any intervention by the child's parent that may affect the dependent variables (watching cartoons, listening to music, etc.)

Treatment and study plan

parental presence

Behavioral

parental presence in PICU

Primary outcomes

  1. comfort scale point

    Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit

    before, during and after the 1st and 5th minute of the visit

Secondary outcomes

  1. heart rate

    Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit

    heart rate will be measured by Braun YK-81CEU

  2. saturation

    Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit

    saturation will be measured by Braun YK-81CEU

  3. respiratory rate

    Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit

    respiratory rate will be measured by Braun YK-81CEU

  4. blood pressure

    Time frame: Baseline, and first minute of the visit and first/fifth minute after the visit

    blood pressure will be measured by Nimo HS-20C Aneroid

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Ardahan Akgül, PhD

CONTACT

[email protected]

+00905544318386

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Dr. Behcet Uz Children's Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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