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

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

      • São Paulo, Brazil, 05652000
        • Hospital Israelita Albert Einstein

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.
Active Comparator: one-sensory self care
Daily moisturizing body care with an odorless moisturizer (Todo Dia® - Natura) for 30 days.
daily use of odorless body moisturizer (Todo Dia® - Natura)
Active Comparator: bi-sensory self care
Daily moisturizing body care with a moisturizer with cotton fragance (Todo Dia® - Natura) for 30 days.
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)
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.
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus

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
Lipp Stress Inventory and Symptoms of Stress List
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
Satisfaction With Life Scale
baseline, 30 days, 60 days
Changes in Positive and Negative Affective
Time Frame: baseline, 30 days, 60 days
Positive and negative affect scale
baseline, 30 days, 60 days
Change in perceived self-esteem (Rosenberg's self-esteem Scale)
Time Frame: baseline, 30 days, 60 days
Rosenberg's self-esteem Scale
baseline, 30 days, 60 days

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.

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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