The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.
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.
1 other identifier
observational
81
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2025
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2025
CompletedJanuary 28, 2026
January 1, 2026
3 months
April 29, 2024
January 27, 2026
Conditions
Keywords
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.
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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dilek YENİAY
Department of Anesthesiolgy, Giresun University
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