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

Primary Purpose

Pain, Postoperative, Surgery, Thoracic

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Routine preoperative information from a nurse
Additional information support from a psychologist
Sponsored by
National Institute for Tuberculosis and Lung Diseases, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Tuberculosis and Lung Diseases, Pediatric Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Routine preoperative information from a nurse

Additional information support from a psychologist

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
Patient satisfaction
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good

Full Information

First Posted
March 22, 2018
Last Updated
April 4, 2018
Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03488459
Brief Title
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia
Official Title
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
December 30, 2014 (Actual)
Study Completion Date
December 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Surgery, Thoracic
Keywords
anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine preoperative information from a nurse
Arm Type
Other
Arm Title
Additional information support from a psychologist
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Routine preoperative information from a nurse
Intervention Description
Routine preoperative information from a nurse.
Intervention Type
Behavioral
Intervention Name(s)
Additional information support from a psychologist
Intervention Description
Routine preoperative information from a nurse + additional information support from a psychologist.
Primary Outcome Measure Information:
Title
Change in anxiety intensity scores
Description
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).
Time Frame
day prior to surgery, postoperative day 2
Secondary Outcome Measure Information:
Title
Pain intensity scores at rest
Description
The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Time Frame
postoperative hours: 1, 2, 4, 11, 24, 48
Title
Pain intensity scores during deep breathing
Description
The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Time Frame
postoperative hours: 1, 2, 4, 11, 24, 48
Title
Pain intensity scores during coughing
Description
The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Time Frame
postoperative hours: 1, 2, 4, 11, 24, 48
Title
Patient satisfaction
Description
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good
Time Frame
postoperative day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute for Tuberculosis and Lung Diseases, Pediatric Division
City
Rabka-Zdrój
State/Province
Małopolska
ZIP/Postal Code
34-700
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23865442
Citation
Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
Results Reference
background
PubMed Identifier
23289773
Citation
Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.
Results Reference
background
PubMed Identifier
22300416
Citation
Fincher W, Shaw J, Ramelet AS. The effectiveness of a standardised preoperative preparation in reducing child and parent anxiety: a single-blind randomised controlled trial. J Clin Nurs. 2012 Apr;21(7-8):946-55. doi: 10.1111/j.1365-2702.2011.03973.x. Epub 2012 Feb 3.
Results Reference
background
PubMed Identifier
30305761
Citation
Tomaszek L, Cepuch G, Fenikowski D. Influence of preoperative information support on anxiety, pain and satisfaction with postoperative analgesia in children and adolescents after thoracic surgery: A randomized double blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):172-178. doi: 10.5507/bp.2018.060. Epub 2018 Oct 5.
Results Reference
derived

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

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