NCT01492452

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 13, 2011

Last Update Submit

December 14, 2011

Conditions

Keywords

guidelines for nursinganxietycardiac surgerypediatrics

Outcome Measures

Primary Outcomes (1)

  • anxiety inventory

    STAI State-Trait Inventory

    five months

Study Arms (1)

guidelines

NO INTERVENTION

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

Interventions

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.

Also known as: parents aged over 18 years
guidelines

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • We included parents aged over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Nursing

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • M A Moraes, Phd

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 15, 2011

Record last verified: 2011-12