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

NCT03488459 | Completed DMC

• 1 other identifier: 10.5
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Surgery, Thoracic

Keywords

anxiety; preoperative education; psychologist; thoracotomy; Ravitch procedure; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain intensity scores at rest

  postoperative hours: 1, 2, 4, 11, 24, 48

• Pain intensity scores during deep breathing

  postoperative hours: 1, 2, 4, 11, 24, 48

• Pain intensity scores during coughing

  postoperative hours: 1, 2, 4, 11, 24, 48

• Patient satisfaction

  postoperative day 2

Study Arms (2)

Routine preoperative information from a nurse

OTHER

Behavioral: Routine preoperative information from a nurse

Additional information support from a psychologist

EXPERIMENTAL

Behavioral: Additional information support from a psychologist

Interventions

Routine preoperative information from a nurse BEHAVIORAL

Routine preoperative information from a nurse.

Routine preoperative information from a nurse

Additional information support from a psychologist BEHAVIORAL

Routine preoperative information from a nurse + additional information support from a psychologist.

Additional information support from a psychologist

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• thoracic surgery (lateral thoracotomy or Ravitch procedure),
• the American Society of Anesthesiologists score 1 or 2.

You may not qualify if:

• presence of a mental disorder,
• anticancer treatment,
• preoperative pain,
• problems with verbal communication ,
• lack of postoperative drainage of the chest.

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland: lead

Study Sites (1)

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

Location

Related Publications (4)

• 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.

  PMID: 23865442 BACKGROUND

• 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.

  PMID: 23289773 BACKGROUND

• 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.

  PMID: 22300416 BACKGROUND

• 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.

  PMID: 30305761 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 5, 2018
• Study Start: March 1, 2012
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

PL (1)