Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752708
• Other study ID #: KB-74/2022
• Status: Recruiting
• Start date: January 16, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: Lucyna Tomaszek, dr hab n. med.
• Phone: +480182676060
• Email: ltomaszek[@]igrabka.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Postoperative
• Anxiety State
• Parents
• Satisfaction
• Surgery
• Thoracic

Intervention

Diagnostic Test:
• Diagnostic Test
Evaluation of perioperative anxiety in parents of children undergoing thoracic surgery using standardized tests: The Amsterdam Preoperative Anxiety and Information Scale (APAIS), the State-Trait Anxiety Inventory (STAI).

Locations

Country	Name	City	State
Poland	National Institute for Tuberculosis and Lung Diseases	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Parents' anxiety state	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	Parents' satisfaction	Satisfaction is assessed on a five-point scale, where 1 means the lowest satisfaction and 5 the highest.	up to discharge from the hospital
Secondary	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