The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.

Anxiety Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404879
• Other study ID #: 25.09.2023/07
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Giresun University
• Contact: DILEK YENIAY
• Phone: +905375521553
• Email: dgyeniay[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Children
• Pain, Postoperative

Intervention

Other:
• determining scores with tests
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.

Locations

Country	Name	City	State
Turkey	Giresun Gynecology and Pediatrics Training Research Hospital	Giresun	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level of parents	It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.	preoperative period
Primary	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
Primary	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	heart rate	beats/min	intraoperative period
Secondary	heart rate	beats/min	up to 8 hour postoperative
Secondary	complication	such as nausea, vomiting and desaturation	up to 24 hour postoperative