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

NCT ID: NCT03488459

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2014-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Surgery, Thoracic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine preoperative information from a nurse

Group Type OTHER

Routine preoperative information from a nurse

Intervention Type BEHAVIORAL

Routine preoperative information from a nurse.

Additional information support from a psychologist

Group Type EXPERIMENTAL

Additional information support from a psychologist

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Routine preoperative information from a nurse

Routine preoperative information from a nurse.

Intervention Type BEHAVIORAL

Additional information support from a psychologist

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Tuberculosis and Lung Diseases, Poland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23865442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23289773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22300416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30305761 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10.5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain Sensitivity During Puberty
NCT05145595 COMPLETED NA