Acute Coronary SyndromeNCT01724762
Efficacy of Nursing Orientation to Reduce the Anxiety of Patients Undergoing Bed Bath
A study testing Nursing Orientation in people with Acute Coronary Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Nursing Orientation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath
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.
Read the detailed description
Patients with acute coronary syndrome present many physiological and psychological changes, especially anxiety, which can be more intense when the patient expects or experiences certain procedures, such as bed bath. The association of anxiety and acute myocardial infarction has shown negative impact on the prognosis of these patients. The anxiety causes activation of the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of patients' anxiety in the face of various nursing procedures is essential to quality care. The anxiety can be reduced using medications and/or nursing orientation.
This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was divided into two phases. The first comprised the development and validation of an informative manual by nurses and patients. The manual was developed by the researchers and then submitted to validation by five nursing professors from the field of nursing fundamentals and five nurses with experience in coronary care units. The Delphi Technique was used to validate the manual in this phase. After validation by nurses, the manual was validated by 35 patients hospitalized in the coronary care unit who experienced bed bath at least once. A score above 4 should be achieved for the manual to be considered comprehensible and validated by patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum test and percentage of score 5 with its confidence interval. The study's second phase comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed baths. The sample population was composed of 120 patients with acute coronary syndrome hospitalized in coronary care units divided into two groups: control group (patients who did not read the informative manual concerning bed bath and received only the unit's routine information) and the intervention group (patients who received nursing orientation and read the informative manual concerning bed bath). The STAI-state was used to assess anxiety. It 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Nursing Orientation
- Keywords
- Baths, Anxiety, Acute Coronary Syndrome, Education, Nursing
- Medical subject headings
- Acute Coronary Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Nursing orientation | Experimental | Patients who received nursing orientation and read the informative manual concerning bed bath Receives: Other: Nursing Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants were followed for the duration of hospital stay, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Juliana de Lima Lopes, Federal University of São Paulo
- Investigators
- Juliana L Lopes, Ms, Principal investigator, Federal University of São PauloAlba LB Barros, PhD, Study director, Federal University of São PauloLuiz A Nogueira-Martins, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724762
- Sponsor's protocol ID
- UNIFESP0447
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20549121Barsevick A, Llewellyn J. A comparison of the anxiety-reducing potential of two techniques of bathing. Nurs Res. 1982 Jan-Feb;31(1):22-7.
PubMed 6922456Tel 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.
PubMed 16543038
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath
- ClinicalTrials.gov ID
- NCT01724762
- Acronym / sponsor ID
- UNIFESP0447
- Conditions
- Acute Coronary Syndrome
- Keywords
- Baths, Anxiety, Acute Coronary Syndrome, Education, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with acute coronary syndrome present many physiological and psychological changes, especially anxiety, which can be more intense when the patient expects or experiences certain procedures, such as bed bath. The association of anxiety and acute myocardial infarction has shown negative impact on the prognosis of these patients. The anxiety causes activation of the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of patients' anxiety in the face of various nursing procedures is essential to quality care. The anxiety can be reduced using medications and/or nursing orientation.
This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was divided into two phases. The first comprised the development and validation of an informative manual by nurses and patients. The manual was developed by the researchers and then submitted to validation by five nursing professors from the field of nursing fundamentals and five nurses with experience in coronary care units. The Delphi Technique was used to validate the manual in this phase. After validation by nurses, the manual was validated by 35 patients hospitalized in the coronary care unit who experienced bed bath at least once. A score above 4 should be achieved for the manual to be considered comprehensible and validated by patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum test and percentage of score 5 with its confidence interval. The study's second phase comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed baths. The sample population was composed of 120 patients with acute coronary syndrome hospitalized in coronary care units divided into two groups: control group (patients who did not read the informative manual concerning bed bath and received only the unit's routine information) and the intervention group (patients who received nursing orientation and read the informative manual concerning bed bath). The STAI-state was used to assess anxiety. It 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing orientation | Experimental | Other: Nursing OrientationPatients who received nursing orientation and read the informative manual concerning bed bath |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Orientation* 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 | Other | Nursing orientation |
Primary outcome
STAI-state
Time frame: Participants were followed for the duration of hospital stay, an average of 2 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
- Results publication: PubMed 20549121Lopes 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.
- Results publication: PubMed 6922456Barsevick A, Llewellyn J. A comparison of the anxiety-reducing potential of two techniques of bathing. Nurs Res. 1982 Jan-Feb;31(1):22-7.
- Results publication: PubMed 16543038Tel 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.
- American Heart AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana L Lopes, Ms principal investigator
Federal University of São Paulo
Alba LB Barros, PhD study director
Federal University of São Paulo
Luiz A Nogueira-Martins study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Orientation in people with Acute Coronary Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI-state (time frame: Participants were followed for the duration of hospital stay, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724762, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.