An observational study in Anxiety State, Anxiety Postoperative and Parents, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Observational
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:
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).
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 123 is below the median of 168 across 977 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →National Institute for Tuberculosis and Lung Diseases, Poland is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Parents of children undergoing thoracic surgery in the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
Time frame: 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).
Time frame: before surgery, before discharge from the hospital
Parents' satisfaction
Satisfaction is assessed on a five-point scale, where 1 means the lowest satisfaction and 5 the highest.
Time frame: up to discharge from the hospital
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
Time frame: perioperative period
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Sep 2025, 32 months after the start.
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National Institute for Tuberculosis and Lung Diseases, Poland