Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Recruiting

• Conditions: Satisfaction; Anxiety State; Parents; Thoracic; Anxiety Postoperative; Surgery

• Registration Number: NCT05752708
• Lead Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland

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).

Study Timeline

• Study Start: 2023-01-16
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-03
• Status Verified: 2024-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parents' anxiety and information requirement in the preoperative phase	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	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 Outcome Measures

Name	Time	Method
Parents' satisfaction	up to discharge from the hospital	Satisfaction is assessed on a five-point scale, where 1 means the lowest satisfaction and 5 the highest.
Socio-demographic factors	perioperative period	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

Trial Locations

Locations (1)

National Institute for Tuberculosis and Lung Diseases; 🇵🇱 Warsaw, Mazowieckie, Poland