NCT06404879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

April 29, 2024

Last Update Submit

January 27, 2026

Conditions

Keywords

childrenanxietyanalgesiapediatricanaesthesia

Outcome Measures

Primary Outcomes (3)

  • Anxiety level of parents

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

    preoperative period

  • Anxiety level of the child undergoing surgery

    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).

    preoperative and intraoperative period

  • Pain levels of children undergoing surgery

    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.

    postoperative period

Secondary Outcomes (3)

  • heart rate

    intraoperative period

  • heart rate

    up to 8 hour postoperative

  • complication

    up to 24 hour postoperative

Study Arms (1)

children group

Are between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study. Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study.

Other: determining scores with tests

Interventions

Parents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves. An anesthesia technician blind to the content of the study will calculate and take notes on the children\'s anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4). FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken.

children group

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who are planned to undergo surgery under general anesthesia due to inguinal area pathology

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Gynecology and Pediatrics Training Research Hospital

Giresun, Centre, 28000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersAgnosia

Condition Hierarchy (Ancestors)

Mental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dilek YENİAY

    Department of Anesthesiolgy, Giresun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation physician

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 8, 2024

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 16, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations