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

April 4, 2018 updated by: National Institute for Tuberculosis and Lung Diseases, Poland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolska
      • Rabka-Zdrój, Małopolska, Poland, 34-700
        • Institute for Tuberculosis and Lung Diseases, Pediatric Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Routine preoperative information from a nurse
Behavioral: Routine preoperative information from a nurse
Routine preoperative information from a nurse.
Experimental: Additional information support from a psychologist
Behavioral: Additional information support from a psychologist
Routine preoperative information from a nurse + additional information support from a psychologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
day prior to surgery, postoperative day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity scores at rest
Time Frame: 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.
postoperative hours: 1, 2, 4, 11, 24, 48
Pain intensity scores during deep breathing
Time Frame: 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.
postoperative hours: 1, 2, 4, 11, 24, 48
Pain intensity scores during coughing
Time Frame: 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.
postoperative hours: 1, 2, 4, 11, 24, 48
Patient satisfaction
Time Frame: postoperative day 2
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good
postoperative day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

December 30, 2014

Study Completion (Actual)

December 30, 2014

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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