NCT02406755

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

October 27, 2014

Last Update Submit

September 1, 2015

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in cortisol levels

    baseline, 30 days, 60 days

Other Outcomes (3)

  • Changes in Satisfaction with life (Satisfaction With Life Scale)

    baseline, 30 days, 60 days

  • Changes in Positive and Negative Affective

    baseline, 30 days, 60 days

  • Change in perceived self-esteem (Rosenberg's self-esteem Scale)

    baseline, 30 days, 60 days

Study Arms (4)

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.

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.

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.

Other: multisensory self care (Todo Dia®)

Interventions

one-sensory self care (Todo Dia®)OTHER

daily use of odorless body moisturizer (Todo Dia® - Natura)

one-sensory self care
multisensory self care (Todo Dia®)OTHER

daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus

multisensory self care
bi-sensory self care (Todo Dia®)OTHER

daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)

bi-sensory self care

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Professional healthcare;
  • working in healthcare or administrative area in hospital
  • Voluntary participation;
  • Signed in term of free and informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652000, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 24860618BACKGROUND

  • 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. Portuguese.

    PMID: 20085165BACKGROUND

  • 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.

    PMID: 28241070DERIVED

Study Officials

  • Eliseth R Leão, PhD

    Hospital Israelita Albert Einstein - Albert Einstein Jewish Institute for Education and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 27, 2014

First Posted

April 2, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

BR(1)