Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia

Not Applicable

Completed

• Conditions: Pain, Postoperative; Surgery, Thoracic
• Interventions: Behavioral: Additional information support from a psychologist; Behavioral: Routine preoperative information from a nurse

• Registration Number: NCT03488459
• Lead Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland

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.

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2014-12-30
• Study Completion: 2014-12-30
• Study First Submitted: 2018-03-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-04
• Last Update Submitted: 2018-04-04
• Study First Posted: 2018-04-05
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional information support from a psychologist	Additional information support from a psychologist	-
Routine preoperative information from a nurse	Routine preoperative information from a nurse	-

Primary Outcome Measures

Name	Time	Method
Change in anxiety intensity scores	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 Outcome Measures

Name	Time	Method
Pain intensity scores during deep breathing	postoperative hours: 1, 2, 4, 11, 24, 48	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Pain intensity scores during coughing	postoperative hours: 1, 2, 4, 11, 24, 48	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Patient satisfaction	postoperative day 2	Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good
Pain intensity scores at rest	postoperative hours: 1, 2, 4, 11, 24, 48	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

Trial Locations

Locations (1)

Institute for Tuberculosis and Lung Diseases, Pediatric Division; 🇵🇱 Rabka-Zdrój, Małopolska, Poland