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The Anxiety of Parents of Children Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01492452
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

This is a randomized clinical trial. The population consisted of parents of children undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18 years, and the following were considered exclusion criteria: inability to understand and/or answer the questions for any reason, parents of children undergoing surgery for insertion of the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the intervention group were randomized and received standardized guidelines for nursing and 22 parents participated in the control group received the guidelines and routine of the institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative period and 48 hours after surgery the child.


Condition Intervention
Anxiety
 Other: standardized guidelines for nursing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Standard Guidelines Impact of Nursing Anxiety of Parents of Children Undergoing Cardiac Surgery: Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • anxiety inventory [ Time Frame: five months ] [ Designated as safety issue: No ]
    STAI State-Trait Inventory


Enrollment: 44
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: guidelines
22 parents in the intervention group were randomized and received standardized guidelines for nursing:The guidelines took around an hour and involved pre-operative care such as bathing with detergent solution, pre-anesthetic administration (as prescribed), preoperative fasting (as prescribed), clothing, hygiene care and nail oral. They were also provided information on the endotracheal tube, tubes, catheters, epicardial pacemaker wires and electrodes to be used in the perioperative period and which remain for some period after surgery, as well as possible complications.
 Other: standardized guidelines for nursing
Information was provided regarding the preoperative preparation of the child, the same conditions and in the postoperative period, as well as information relating to housing and food for the parents. The conventional orientation took about 15 minutes.
Other Name: parents aged over 18 years

Detailed Description:

anxiety

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We included parents aged over 18 years

Exclusion Criteria:

  • inability to understand and/or answer the questions for any reason,
  • parents of children undergoing surgery for insertion of the pacemaker and defibrillator,
  • surgical death and not take up the case
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492452

Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
Principal Investigator: M A Moraes, Phd Institute of Cardiology
  More Information

No publications provided

Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01492452     History of Changes
Other Study ID Numbers: UP4555/10
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
guidelines for nursing
anxiety
cardiac surgery
pediatrics

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013