This study investigated the effects of aromatherapy massage with geranium and placebo on depression in menopausal women who came to a university health care center. A total of 120 women who had a score of 14 or more on Beck questionnaire and didn’t have any history of hormone therapy or depression treatment, were recruited and assigned into control group or massage with geranium in almond oil or massage with almond oil alone, once weekly for 8 weeks. Intensity of depression was measured by using Beck questionnaire and compared between groups after the treatment and after one month follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811061061N6
Registration date:2010-12-14, 1389/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-14, 1389/09/23
Registrant information
Name
Reza Vazirinejad
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0097
Email address
pejoheshi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University Of Medical Sciences
Expected recruitment start date
2010-10-12, 1389/07/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Aromatherapy Massage With Geranium And conventional Massage on Menopausal Depression in Rafsanjan
Public title
Comparison of Aromatherapy Massage With Geranium And conventional Massage on Menopausal Depression in Rafsanjan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age equal or more than 50 years old, more than a year passed since the last menstrual period, Beck score equal or more than 14,
Exclusion criteria: having any olfactory disorder, history of cancer and any other chronic diseases, any history of allergy, presence of respiratory disease, cigarette smoking, presence of ulcer, redness, edema, or indurations on the skin, any contraindication for massage, absence in therapeutic sessions more than 2 times, receiving any other effective medicine during the trial
Age
From 50 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Boulevard, Ayat Alla Saidi Square
City
Rarsanjan
Postal code
Approval date
2010-10-02, 1389/07/10
Ethics committee reference number
1015/20/9
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Depressive Disorder
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline, after the treatment, one month after the completion of treatrment
Method of measurement
Beck questionnairre
Secondary outcomes
empty
Intervention groups
1
Description
Massage with 10cc geranium 2% in almond oil, using Effleurage Method on Back, Shoulder and Abdomen, 30 minutes a week, for 8 weeks
Category
Treatment - Other
2
Description
Massage with 10cc almond oil alone, using Effleurage Method on Back, Shoulder and Abdomen, 30 minutes a week, for 8 weeks
Category
Placebo
3
Description
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
University health centers
Full name of responsible person
Street address
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University Of Medical Sciences
Full name of responsible person
Dr Reza Vaziri Nezhad
Street address
Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Boulevard, Ayat Alla Saidi Square
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University Of Medical Sciences
Full name of responsible person
Seyedeh Maryam Lotfipur Rafsanjani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery
City
Rafsanjan
Postal code
Phone
+98 39 1522 5900
Fax
Email
m_lotfi@rums.ic.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University Of Medical Sciences
Full name of responsible person
Monavar Maderi
Position
Research Expert
Other areas of specialty/work
Street address
Ayat Alla Saidi Squar, Emam Ali Bolvard, Central Organization Of University
City
Rafsanjan
Postal code
Phone
+98 39 1822 0086
Fax
+98 39 1822 0074
Email
monanaderi56@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)