H-Senses Project - Self Care Mediated by the Senses

Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406755
• Other study ID #: H-Senses
• Status: Completed
• Phase: N/A
• First received: October 27, 2014
• Last updated: September 1, 2015
• Start date: July 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• one-sensory self care (Todo Dia®)
daily use of odorless body moisturizer (Todo Dia® - Natura)
• multisensory self care (Todo Dia®)
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus
• bi-sensory self care (Todo Dia®)
daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Caminha LB, da Silva MJ, Leão 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. Portuguese. Erratum in: Rev Esc Enferm USP. 2010 Mar;44(1):following 227. — View Citation

Ribeiro VF, Filho CF, Valenti VE, Ferreira M, de Abreu LC, de Carvalho TD, Xavier V, de Oliveira Filho J, Gregory P, Leão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Satisfaction with life (Satisfaction With Life Scale)	Satisfaction With Life Scale	baseline, 30 days, 60 days	No
Other	Changes in Positive and Negative Affective	Positive and negative affect scale	baseline, 30 days, 60 days	No
Other	Change in perceived self-esteem (Rosenberg's self-esteem Scale)	Rosenberg's self-esteem Scale	baseline, 30 days, 60 days	No
Primary	Change in perceived stress (Lipp Stress Inventory and Symptoms of Stress List)	Lipp Stress Inventory and Symptoms of Stress List	baseline, 30 days, 60 days	No
Secondary	Change in cortisol levels	Saliva will be collected to measure cortisol levels: 7-9 am	baseline, 30 days, 60 days	No