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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Surgery, Thoracic

Intervention / Treatment
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* Behavioral: Routine preoperative information from a nurse
* Behavioral: Additional information support from a psychologist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Routine preoperative information from a nurse<br> | Behavioral: Routine preoperative information from a nurse<br>* Routine preoperative information from a nurse.<br>|
| Experimental: Additional information support from a psychologist<br> | Behavioral: Additional information support from a psychologist<br>* Routine preoperative information from a nurse + additional information support from a psychologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety intensity scores | 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). | day prior to surgery, postoperative day 2 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain