Clinical trial NCT03488459: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Surgery, Thoracic
Keywords: anxiety
preoperative education
psychologist
thoracotomy
Ravitch procedure
postoperative pain
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 112
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in anxiety intensity scores
timeFrame: day prior to surgery, postoperative day 2
Secondary outcomes:
measure: Pain intensity scores at rest
timeFrame: postoperative hours: 1, 2, 4, 11, 24, 48
measure: Pain intensity scores during deep breathing
timeFrame: postoperative hours: 1, 2, 4, 11, 24, 48
measure: Pain intensity scores during coughing
timeFrame: postoperative hours: 1, 2, 4, 11, 24, 48
measure: Patient satisfaction
timeFrame: postoperative day 2
Other outcomes:
Locations:
city: Rabka-Zdrój
country: Poland
facility: Institute for Tuberculosis and Lung Diseases, Pediatric Division
state: Małopolska
Study officials:
References:
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.
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.
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.
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.