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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01492452
Other study ID # UP4555/10
Secondary ID
Status Completed
Phase N/A
First received December 13, 2011
Last updated December 14, 2011
Start date December 2010
Est. completion date May 2011

Study information

Verified date December 2011
Source Instituto de Cardiologia do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

anxiety


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type Measure Description Time frame Safety issue
Primary anxiety inventory STAI State-Trait Inventory five months No
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