Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

NCT05752708 | Recruiting DMC

• 1 other identifier: KB-74/2022
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety State; Anxiety Postoperative; Parents; Surgery; Thoracic; Satisfaction

Keywords

anxiety, parents, thoracic surgery, perioperative, parents' satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Parents' satisfaction

  up to discharge from the hospital

• Socio-demographic factors

  perioperative period

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland: lead

Study Sites (1)

National Institute for Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, 01-138, Poland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lucyna Tomaszek, PhD

  National Institute for Tuberculosis and Lung Diseases, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucyna Tomaszek, dr hab n. med.

CONTACT

+480182676060; ltomaszek@igrabka.edu.pl

Nina Cież

CONTACT

+480182676060; nciez@igrabka.edu.pl

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: January 16, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

PL (1)