Skip to main content
Clinical Trials/NCT03488459
NCT03488459
Completed
Not Applicable

Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study

National Institute for Tuberculosis and Lung Diseases, Poland1 site in 1 country112 target enrollmentMarch 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Enrollment
112
Locations
1
Primary Endpoint
Change in anxiety intensity scores
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.

Detailed Description

The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.

Registry
clinicaltrials.gov
Start Date
March 1, 2012
End Date
December 30, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • thoracic surgery (lateral thoracotomy or Ravitch procedure),
  • the American Society of Anesthesiologists score 1 or 2.

Exclusion Criteria

  • presence of a mental disorder,
  • anticancer treatment,
  • preoperative pain,
  • problems with verbal communication ,
  • lack of postoperative drainage of the chest.

Outcomes

Primary Outcomes

Change in anxiety intensity scores

Time Frame: day prior to surgery, postoperative day 2

Anxiety was determined with a Polish version of the self-inventory, either for children between 9 and 14 years of age, i.e. State-Trait Anxiety Inventory for Children (STAI-C; range: 20-60 pts) or for adolescents, i.e. State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. In this study, the levels of anxiety were determined twice: one day prior to surgery (both trait and state anxiety) and 48 h after the procedure (only state anxiety). The results were 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 Outcomes

  • Pain intensity scores during deep breathing(postoperative hours: 1, 2, 4, 11, 24, 48)
  • Pain intensity scores during coughing(postoperative hours: 1, 2, 4, 11, 24, 48)
  • Patient satisfaction(postoperative day 2)
  • Pain intensity scores at rest(postoperative hours: 1, 2, 4, 11, 24, 48)

Study Sites (1)

Loading locations...

Similar Trials