Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752708
Collaborator
(none)
123
1
23.5
5.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
123 participants
Observational Model:
Family-Based
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery
Actual Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute for Tuberculosis and Lung Diseases Warsaw Mazowieckie Poland 01-138

Sponsors and Collaborators

  • National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Institute for Tuberculosis and Lung Diseases, Poland
ClinicalTrials.gov Identifier:
NCT05752708
Other Study ID Numbers:
  • KB-74/2022
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institute for Tuberculosis and Lung Diseases, Poland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023