- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06404879
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Centre
-
Giresun, Centre, Turkey (Türkiye), 28000
- Giresun Gynecology and Pediatrics Training Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level of parents
Time Frame: preoperative period
|
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
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).
|
preoperative and intraoperative period
|
|
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.
|
postoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart rate
Time Frame: intraoperative period
|
beats/min
|
intraoperative period
|
|
heart rate
Time Frame: up to 8 hour postoperative
|
beats/min
|
up to 8 hour postoperative
|
|
complication
Time Frame: up to 24 hour postoperative
|
such as nausea, vomiting and desaturation
|
up to 24 hour postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilek YENİAY, Department of Anesthesiolgy, Giresun University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.09.2023/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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