Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Evaluation of Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery.

The purpose of the study is:

1. assessment of the level of anxiety experienced by parents before and after thoracic surgery,
2. assessment of risk factors for parents' perioperative anxiety,
3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

Study Overview

• Status: Recruiting
• Conditions: Surgery; Parents; Anxiety State; Satisfaction; Thoracic; Anxiety Postoperative
• Intervention / Treatment: Diagnostic test: Diagnostic Test

Detailed Description

According to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. It was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. Parental anxiety correlates positively with child anxiety. High levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).

• Study Type: Observational
• Enrollment (Anticipated): 123

Contacts and Locations

• Study Contact: Name: Lucyna Tomaszek, dr hab n. med.; Phone Number: 243 +480182676060; Email: ltomaszek@igrabka.edu.pl
• Study Contact Backup: Name: Nina Cież; Phone Number: 256 +480182676060; Email: nciez@igrabka.edu.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 01-138
      • Recruiting
      • National Institute for Tuberculosis and Lung Diseases
      • Contact: Lucyna Tomaszek, dr hab. n. med.; Phone Number: 243 +48182676060; Email: ltomaszek@igrabka.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Parents of children undergoing thoracic surgery in the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch.

Description

Inclusion Criteria:

• parent of child <18 years
• parent of child undergoing thoracic surgery
• parent of child with intravenous or epidural postoperative analgesia
• parent of child with 1-3 score according to the American Society of Anesthesiologists

Exclusion Criteria:

• a parent of a nationality other than Polish
• difficult communication with parent
• parent of a child undergoing oncological treatment
• parent of a child without chest drainage
• lack of parental consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents' anxiety and information requirement in the preoperative phase	The Amsterdam Preoperative Anxiety and Information Scale (APAIS) consists of six items. The items are rated on a five point Likert scale with the end poles "not at all" (1) and "extremely" (5). It represents the two scales anxiety (Item 1, 2, 4 and 5) and need-for-information (Items 3 and 6). A total value is calculated by adding up the two scales anxiety and need-for-information. A higher score means higher preoperative anxiety and a greater need for information.	before surgery
Change in anxiety intensity scores	Anxiety was determined with a Polish version of the State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. The results will be expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, >7 = high level of anxiety).	before surgery, before discharge from the hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents' satisfaction	Satisfaction is assessed on a five-point scale, where 1 means the lowest satisfaction and 5 the highest.	before discharge from the hospital
Socio-demographic factors	Socio-demographic variables include: age, sex, education, marital status, income, place of residence, number of children, number of operations/hospitalizations of the child, scope of information obtained before the operation, postoperative pain and complication in a child	perioperative period

Collaborators and Investigators

• Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
• Investigators: Principal Investigator: Lucyna Tomaszek, PhD, National Institute for Tuberculosis and Lung Diseases, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Estimate): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: anxiety, parents, thoracic surgery, perioperative, parents' satisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KB-74/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No