NCT01724762

Brief Summary

This study's general objective was to evaluate the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific objectives included: the development and validation of an informative manual concerning bed bath; correlation of physiological variables (systolic and diastolic blood pressure and heart and respiratory rate) with the patients' state anxiety; correlation of antecedent variables (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression, prior hospitalization, prior experience with bed baths, the patients' preference for a female or male professional to perform the bath, pain, fear, and embarrassment) with the patients' state anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

1.5 years

First QC Date

November 6, 2012

Last Update Submit

November 9, 2012

Conditions

Acute Coronary Syndrome

Keywords

BathsAnxietyAcute Coronary SyndromeEducation, Nursing

Outcome Measures

Primary Outcomes (1)

  • STAI-state

    The STAI-state was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.

    Participants were followed for the duration of hospital stay, an average of 2 weeks

Study Arms (1)

Nursing orientation

EXPERIMENTAL

Patients who received nursing orientation and read the informative manual concerning bed bath

Other: Nursing Orientation

Interventions

Nursing OrientationOTHER

* Control group: patients who did not read the informative manual concerning bed bath and received only the unit's routine information * Intervention group: patients who received nursing orientation and read the informative manual concerning bed bath

Nursing orientation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute coronary syndrome Killip 1
  • Patients who were undergoing the bed bath for the first time in the current hospitalization
  • Literate and at least 4 years of study
  • Patients with age less than 75 years
  • Patients who agreed to participate

You may not qualify if:

  • Patients with vascular diseases or arteriovenous fistulas in the left arm
  • Situations that could influence patients' anxiety and / or vital signs (arrhythmias such as ventricular tachycardia, second or third-degree atrioventricular block ; ischemic pain before, during or after bath; patients with Killip 2, 3 and 4; invasive procedures on the day of data collection, such as catheterization and surgery, and use of benzodiazepines and / or anxiolytics
  • Situations in which patients were not able to complete the questionnaires (altered level of consciousness, visual impairment and / or patients who could not read and / or write)
  • Situations in which the patient requested information about bed bath, previously the beginning of the evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04021-001, Brazil

Location

Related Publications (3)

  • Lopes Jde L, Nogueira-Martins LA, Goncalves MA, de Barros AL. Comparing levels of anxiety during bed and shower baths in patients with acute myocardial infarction. Rev Lat Am Enfermagem. 2010 Mar-Apr;18(2):217-23. doi: 10.1590/s0104-11692010000200012.

    PMID: 20549121RESULT

  • Barsevick A, Llewellyn J. A comparison of the anxiety-reducing potential of two techniques of bathing. Nurs Res. 1982 Jan-Feb;31(1):22-7.

    PMID: 6922456RESULT

  • Tel H, Tel H. The effect of individualized education on the transfer anxiety of patients with myocardial infarction and their families. Heart Lung. 2006 Mar-Apr;35(2):101-7. doi: 10.1016/j.hrtlng.2005.09.001.

    PMID: 16543038RESULT

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeAnxiety Disorders

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMental Disorders

Study Officials

  • Juliana L Lopes, Ms

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Alba LB Barros, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

  • Luiz A Nogueira-Martins

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 12, 2012

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

BR(1)