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Clinical Trials/NCT06404879
NCT06404879
Completed
Not Applicable

The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.

Giresun University1 site in 1 country81 target enrollmentJanuary 1, 2025
ConditionsAnxietyChildren

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Giresun University
Enrollment
81
Locations
1
Primary Endpoint
Pain levels of children undergoing surgery
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child's preoperative anxiety level and postoperative pain level.

Detailed Description

Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\'s preoperative anxiety level and postoperative pain level.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
May 16, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dilek Yeniay

Anesthesiology and Reanimation physician

Giresun University

Eligibility Criteria

Inclusion Criteria

  • The child is between the ages of 2-6
  • Patients scheduled for surgery under general anesthesia due to inguinal area pathology
  • Surgery performed as planned
  • There is no mental or neurological disorder in both the mother and the child.
  • There are no vision, hearing or speech problems in both the mother and the child.
  • Parents and children who volunteer to participate in the research
  • Children with ASA I

Exclusion Criteria

  • Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
  • Those who underwent surgery with a pathology other than the inguinal area
  • Having emergency surgery
  • Children at risk with ASA 2 and above
  • Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).

Outcomes

Primary Outcomes

Pain levels of children undergoing surgery

Time Frame: postoperative period

Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.

Anxiety level of the child undergoing surgery

Time Frame: preoperative and intraoperative period

According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

Anxiety level of parents

Time Frame: preoperative period

It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.

Secondary Outcomes

  • heart rate(up to 8 hour postoperative)
  • complication(up to 24 hour postoperative)

Study Sites (1)

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