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Clinical Trials/NCT05752708
NCT05752708
Recruiting
Not Applicable

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

National Institute for Tuberculosis and Lung Diseases, Poland1 site in 1 country123 target enrollmentJanuary 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety State
Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Enrollment
123
Locations
1
Primary Endpoint
Parents' anxiety and information requirement in the preoperative phase
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
January 16, 2023
End Date
September 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Parents' anxiety and information requirement in the preoperative phase

Time Frame: before surgery

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.

Parents' anxiety state

Time Frame: before surgery, before discharge from the hospital

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).

Secondary Outcomes

  • Parents' satisfaction(up to discharge from the hospital)
  • Socio-demographic factors(perioperative period)

Study Sites (1)

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