The comparison of Massage therapy & Aromatherapy massage done by midwife & and study subjects on menopausal symptoms in 45-60 years old women attendant to menopausal clinic
The objective of this randomized clinical trial is to compare Massage therapy & Aromatherapy massage by a midwife on the menopausal symptoms. A total of 150 women who have naturally enter the menopausal period and have menopausal symptoms according to MRS, will be randomly assigned to aromatherapy massage groups (by a midwife or themselves), massage group (by midwife or themselves), or control. The outcome (menopausal symptoms, as obtained through the Menopause Rating Scale) will be measured before intervention, and after 4 weeks intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101262172N9
Registration date:2011-10-27, 1390/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Massage therapy & Aromatherapy massage done by midwife & and study subjects on menopausal symptoms in 45-60 years old women attendant to menopausal clinic
Public title
The effect of Massage therapy & Aromatherapy massage done by midwife & and study subjects on menopausal symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 45 and 60 years old; married; 12 months amenorrhea; no serious chronic medical conditions; no allergy to aromatherapy; normal pap smear in past 12 months; no clinically abnormal finding in physical examinations.
Exclusion criteria: side effects during intervention for example allergy to aromatherapy; absence of maximum two sessions of intervention; any kind of crisis in participant or her family; use of any kind of drug or therapy for symptom relief during the study intervention; change in diet or physical exercise program during the study
Age
From 45 years old to 60 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Department
Street address
No 23, Dameshgh St. Valiasr Ave
City
Tehran
Postal code
Approval date
2011-03-21, 1390/01/01
Ethics committee reference number
12849-28-01-90
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Menopausal symptoms scores
Timepoint
Before intervention, after 4 weeks intervention
Method of measurement
Menopausal Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Massage therapy by midwife: massage with plane oil (5 cc of soft paraffin per session) on the abdominal area, arm and femur, applied by midwife, eight 30-min sessions over a month
Category
Other
2
Description
Control: No intervention during the study
Category
Other
3
Description
Aromatherapy massage by midwife: aromatherapy massage with aroma oil (5 cc of lavender, rose geranium, rose and rosemary in a 4:2:1:1 ratio, diluted almond (90%) and evening primrose oil (10%) at a final concentration of 3% per session) on the abdominal area, arm and femur, applied by midwife, eight 30-min sessions over a month
Category
Other
4
Description
Aromatherapy massage by participants: aromatherapy massage with aroma oil (5 cc of lavender, rose geranium, rose and rosemary in a 4:2:1:1 ratio, diluted almond (90%) and evening primrose oil (10%) at a final concentration of 3% per session) on the abdominal area, arm and femur, applied by participants, eight 30-min sessions over a month
Category
Other
5
Description
Massage therapy by participants: massage with plane oil (5 cc of soft paraffin per session) on abdominal area, arm and femur, applied by participants, eight 30-min sessions over a month
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Menopause Clinic of OB & GYN hospital (Mirza koochak khan)