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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-6mgqn3
Date of registration: 11/09/2017
Prospective Registration: No
Primary sponsor: Departamento de Enfermagem da Universidade Estadual Paulista
Public title: The use of Aromatherapy associated with Massagem on Stress from a nursing staff at the surgical center
Scientific title: Aromatherapy with Massage on Stress from a nursing staff at the surgical center
Date of first enrolment: 04/07/2016
Target sample size:
Recruitment status: Data analysis completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-6mgqn3
Study type:  Intervention
Study design:  Clinical trial of a randomized-controlled, parallel, uni-blind treatment with two arms  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Eliana Mara   Braga
Address:  Av. Prof. Mário Rubens Guimarães Montenegro, s/n Bairro: UNESP - Campus de Botucatu 18618687 Botucatu Brazil
Telephone: 55(14)3008-1001
Email: elmara@fmb.unesp.br
Affiliation:  Faculdade de Medicina de Botucatu
Name: Thiago da Silva   Domingos
Address:  Av. Prof. Mário Rubens Guimarães Montenegro, s/n Bairro: UNESP - Campus de Botucatu 18618687 Botucatu Brazil
Telephone: 55(14)3008-1001
Email: thiagosd7@hotmail.com
Affiliation:  Faculdade de Medicina de Botucatu
Key inclusion & exclusion criteria
Inclusion criteria: Healthy volunteers; both genders; age between 18 and 60 years; to be working regularly in the sector (surgical center); to consent participate in the research by signing the Free and Informed Consent Form; achieve a minimum score of 12 points on Vasconcelos Stress Symptom List; olfactory acceptance of the odor of lavender (Lavandula angustifolia) and geranium (Pelargonium graveolens) essential oils; and declare not being pregnant.
Exclusion criteria: Loss of follow-up of aromatherapy massage sessions.

Age minimum: 18Y
Age maximum: 60Y
Gender: -
Health Condition(s) or Problem(s) studied
Occupational Diseases
Intervention(s)
E02.190.525.061
E02.190.599.750.750
Intervention Group: Nineteen nursing staff with at least a low level of stress received six aromatherapy massages on alternate days that lasted 10 to 15 minutes. The massage protocol consisted in the use of distributed smoothing in linear movements applied in the posterior cervical and thoracic regions. The cream for the massage was based on neutral cream, where essential oil of lavender (Lavandula angustifolia) and geranium (Pelargonium graveolens) were diluted in concentration of 1% each. Each participant used by massage 10mL of aromatic cream. In addition to this procedure, before the beginning of each massage, the 19 participants had their heart rate and blood pressure checked. The questionnaires investigate stress index of the participants was applied before the first massage and after the sixth massage, when finalizing the study protocol. Control group: 19 nursing staff with at least a low level of stress remained untreated for two weeks (which corresponded to the intervention period in the control group) and again responded to the questionnaire assessing stress levels.
Other
Primary Outcome(s)
Expected outcome: decrease in stress scores verified by applying the Stress Symptom List (nationally validated instrument) evidenced by moving to a less intense stress level after six aromatherapy massage sessions.
Outcome found: There was no change to less intense levels of stress. There was observed a decrease in the scores of stress levels through the application of Stress Symptoms List (validated instrument nationally) after six sessions of massage with aromatherapy, however, the statistical analysis did not detect significance between experimental and control groups, considered p-value 0.05.

Statistical data of the intragroup analysis: Control Group: LSS before 45,11 (SD 30,62); after 44.44 (DP 30.54), p-value = 0.99. Intervention Group: LSS before 52.15 (DP 30.04); after 46.31 (SD 30.42), p-value = 0.92. Statistical data from the intergroup analysis: LSS before-control group 45.11 (SD 30.62) and intervention group 52.15 (SD 30.04), p-value = 0.87. LSS after-control group 44.44 (SD 30.54) and the intervention group 46.31 (SD 30.42), p-value = 0.92.
Secondary Outcome(s)
Expected outcomes: decreased manual heart rate, assisted by digital clock, before and after each aromatherapy massage session. Decrease of systolic blood pressure verified by aneroid sphygmomanometer, before and after each session of aromatherapy massage. Decrease in diastolic blood pressure as measured by an aneroid sphygmomanometer before and after each aromatherapy massage session.
Outcome founds: There was a decrease in heart rate for all six aromatherapy massage sessions with statistical significance, considered p-value 0.05. There was a decrease in systolic blood pressure for all aromatherapy massage sessions with statistical significance, considering p-value 0.05. There was a decrease in diastolic blood pressure for all sessions of massage with aromatherapy, however, statistical analysis showed significant result only from second to sixth massage session, considering p-value 0.05.

Statistical data of heart rate (intervention group): 1st session - 66.53 (13.96); 57.97 (9.52); p-value <0.0001; 2nd session - 65.32 (SD 9.74); 59.11 (DP 9.52); p-value <0.0001; 3rd session - 64.11 (DP 9.24); 59.26 (DP 9.80); p-value <0.0001; 4th session - 66.75 (SD 10.29); 62.05 (DP 10.31); p-value <0.0001; 5th session - 62.53 (SD 8.17); 57.05 (SD 11.76); p-value <0.0091; 6th session - 65.26 (SD 8.04); 57.05 (DP 8.11); p-value <0.0001.

Statistical data of systolic blood pressure: 1st session - 120.53 (SD 15.08); 107.26 (DP 12.41); p-value <0.001; 2nd session - 123.68 (DP 13.00); 111.05 (DP 12.43); p-value <0.001; 3rd session - 125.79 (DP 13.46); 112.63 (DP 12.84); p-value <0.001; 4th session - 128.95 (DP 9.80); 115.79 (DP 9.61); p-value <0.001; 5th session - 131.58 (DP 18.34); 119.47 (DP 15.45); p-value <0.001; 6th session - 124.74 (SD 16.11); 112.63 (DP 12.84); p-value <0.001.

Statistical data of diastolic blood pressure: 1st session - 71.42 (SD 18.61); 69.37 (DP 7.95); p-value = 0.59; 2nd session - 78.42 (DP 7.65); 68.95 (DP 7.37); p-value <0.001; 3rd session - 77.63 (DP 7.88); 72.89 (DP 7.87); p-value = 0.0018; 4th session - 78.68 (SD 5.74); 73, 95 (DP 6.79); p-value = 0.0069; 5th session - 80.26 (SD 9.50); 72.11 (DP = 8.55); p-value = 0.001; 6th session - 75.79 (DP 9.02); 71.05 (DP 8.75); p-value = 0.015.
Secondary ID(s)
Source(s) of Monetary Support
Universidade Estadual Paulista
Faculdade de Medicina de Botucatu
Secondary Sponsor(s)
Universidade Estadual Paulista
Faculdade de Medicina de Botucatu
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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