- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406755
H-Senses Project - Self Care Mediated by the Senses
September 1, 2015 updated by: Eliseth Ribeiro Leao, Hospital Israelita Albert Einstein
H-SENSES PROJECT Self Care Mediated by the Senses: Assessing the Impact on Self-esteem, Stress and Well-being of Female Health Professionals
Randomized clinical trial about self-care mediated by the senses in female health professionals and their influence on stress, self-esteem, mood states, life satisfaction and levels of salivary cortisol.
Study Overview
Status
Completed
Conditions
Detailed Description
The work environment of health professionals is commonly considered stressful, given that they need to deal with difficult situations that include pain, risk of death, the decisions that need to be fast and accurate, and conflicts generated in interpersonal relationships.
There is an ongoing discussion that the investigators need to care for those who care, however, there are few interventions studied and validated to effectively reduce the stress of these professionals that resonate in states of well-being.
There is little room for discussion of this topic during the workday, as well as to learn techniques and measures for effective stress management.
This study aims to explore the relationship between well-being, self-esteem and stress of women health professionals, and compare three self-care interventions mediated by the senses.
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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São Paulo, Brazil, 05652000
- Hospital Israelita Albert Einstein
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Professional healthcare;
- working in healthcare or administrative area in hospital
- Voluntary participation;
- Signed in term of free and informed consent.
Exclusion Criteria:
- Evaluation with relevant dermatological findings diagnosed by a dermatologist;
- Work at nighttime or in alternate periods (because of known chronobiological changes that would affect the study of cortisol, one of the outcomes considered in the study);
- who are breastfeeding;
- Be pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
This control group will not receive an intervention.
|
|
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Active Comparator: one-sensory self care
Daily moisturizing body care with an odorless moisturizer (Todo Dia® - Natura) for 30 days.
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daily use of odorless body moisturizer (Todo Dia® - Natura)
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Active Comparator: bi-sensory self care
Daily moisturizing body care with a moisturizer with cotton fragance (Todo Dia® - Natura) for 30 days.
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daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)
|
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Active Comparator: multisensory self care
Daily moisturizing body care with a moisturizer with cotton fragance (Todo Dia® - Natura) for 30 days, and will watch a video with music and images of nature during self-care.
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daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived stress (Lipp Stress Inventory and Symptoms of Stress List)
Time Frame: baseline, 30 days, 60 days
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Lipp Stress Inventory and Symptoms of Stress List
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baseline, 30 days, 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cortisol levels
Time Frame: baseline, 30 days, 60 days
|
Saliva will be collected to measure cortisol levels: 7-9 am
|
baseline, 30 days, 60 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Satisfaction with life (Satisfaction With Life Scale)
Time Frame: baseline, 30 days, 60 days
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Satisfaction With Life Scale
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baseline, 30 days, 60 days
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Changes in Positive and Negative Affective
Time Frame: baseline, 30 days, 60 days
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Positive and negative affect scale
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baseline, 30 days, 60 days
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Change in perceived self-esteem (Rosenberg's self-esteem Scale)
Time Frame: baseline, 30 days, 60 days
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Rosenberg's self-esteem Scale
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baseline, 30 days, 60 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eliseth R Leão, PhD, Hospital Israelita Albert Einstein - Albert Einstein Jewish Institute for Education and Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ribeiro VF, Filho CF, Valenti VE, Ferreira M, de Abreu LC, de Carvalho TD, Xavier V, de Oliveira Filho J, Gregory P, Leao ER, Francisco NG, Ferreira C. Prevalence of burnout syndrome in clinical nurses at a hospital of excellence. Int Arch Med. 2014 May 9;7:22. doi: 10.1186/1755-7682-7-22. eCollection 2014.
- Caminha LB, da Silva MJ, Leao ER. [The influence of musical rhythms on the perception of subjective states of adult patients on dialysis]. Rev Esc Enferm USP. 2009 Dec;43(4):923-9. doi: 10.1590/s0080-62342009000400026. Erratum In: Rev Esc Enferm USP. 2010 Mar;44(1):following 227. Portuguese.
- Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
October 27, 2014
First Submitted That Met QC Criteria
April 1, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Estimate)
September 3, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- H-Senses
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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