StressNCT02406755
H-Senses Project - Self Care Mediated by the Senses
A study testing one-sensory self care (Todo Dia®), multisensory self care (Todo Dia®) and bi-sensory self care (Todo Dia®) in people with Stress, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- one-sensory self care (Todo Dia®), multisensory self care (Todo Dia®) and bi-sensory self care (Todo Dia®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Aug 2015
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Professional healthcare;
- working in healthcare or administrative area in hospital
- Voluntary participation;
- Signed in term of free and informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- one-sensory self care (Todo Dia®), multisensory self care (Todo Dia®), bi-sensory self care (Todo Dia®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-sensory self care (Todo Dia®)Other
daily use of odorless body moisturizer (Todo Dia® - Natura)
multisensory self care (Todo Dia®)Other
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus
bi-sensory self care (Todo Dia®)Other
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This control group will not receive an intervention. |
| one-sensory self care | Active comparator | Daily moisturizing body care with an odorless moisturizer (Todo Dia® - Natura) for 30 days. Receives: Other: one-sensory self care (Todo Dia®) |
| bi-sensory self care | Active comparator | Daily moisturizing body care with a moisturizer with cotton fragance (Todo Dia® - Natura) for 30 days. Receives: Other: bi-sensory self care (Todo Dia®) |
| multisensory self care | Active comparator | 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. Receives: Other: multisensory self care (Todo Dia®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress (Lipp Stress Inventory and Symptoms of Stress List)
Lipp Stress Inventory and Symptoms of Stress List
Measured: baseline, 30 days, 60 days
Secondary outcomes (1)
Change in cortisol levels
Saliva will be collected to measure cortisol levels: 7-9 am
Measured: baseline, 30 days, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionAug 2015
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 StressStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliseth Ribeiro Leao, Hospital Israelita Albert Einstein
- Investigators
- Eliseth R Leão, PhD, Principal investigator, Hospital Israelita Albert Einstein - Albert Einstein Jewish Institute for Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406755
- Sponsor's protocol ID
- H-Senses
- Status last verified
- Sep 2015
- First submitted
- 27 Oct 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24860618Caminha 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. Portuguese.
PubMed 20085165Leao 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.
PubMed 28241070
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-SENSES PROJECT Self Care Mediated by the Senses: Assessing the Impact on Self-esteem, Stress and Well-being of Female Health Professionals
- ClinicalTrials.gov ID
- NCT02406755
- Acronym / sponsor ID
- H-Senses
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Apr 2015 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This control group will not receive an intervention. |
| one-sensory self care | Active comparator | Other: one-sensory self care (Todo Dia®)Daily moisturizing body care with an odorless moisturizer (Todo Dia® - Natura) for 30 days. |
| bi-sensory self care | Active comparator | Other: bi-sensory self care (Todo Dia®)Daily moisturizing body care with a moisturizer with cotton fragance (Todo Dia® - Natura) for 30 days. |
| multisensory self care | Active comparator | Other: multisensory self care (Todo Dia®)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Professional healthcare;
- working in healthcare or administrative area in hospital
- Voluntary participation;
- Signed in term of free and informed consent.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| one-sensory self care (Todo Dia®)daily use of odorless body moisturizer (Todo Dia® - Natura) | Other | one-sensory self care |
| multisensory self care (Todo Dia®)daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus | Other | multisensory self care |
| bi-sensory self care (Todo Dia®)daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) | Other | bi-sensory self care |
Primary outcome
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
1 secondary outcome
Change in cortisol levels
Time frame: baseline, 30 days, 60 days
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 3 Sep 2015.
- Background: PubMed 24860618Ribeiro 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.
- Background: PubMed 20085165Caminha 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. Portuguese.
- Derived from this study: PubMed 28241070Leao 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.
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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.
Eliseth R Leão, PhD principal investigator
Hospital Israelita Albert Einstein - Albert Einstein Jewish Institute for Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one-sensory self care (Todo Dia®), multisensory self care (Todo Dia®) and bi-sensory self care (Todo Dia®) in people with Stress, run by Hospital Israelita Albert Einstein 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 4 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 3 Sep 2015. 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?
Change in perceived stress (Lipp Stress Inventory and Symptoms of Stress List) (time frame: baseline, 30 days, 60 days). 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 NCT02406755, 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 3 Sep 2015.