The effect of aromatherapy on mood states and resilience of pregnant women referring to selected health centers in Isfahan, Iran (2021)
Design
Clinical trial, with intervention and control groups, without blinding, randomized, on 70 pregnant mothers, 2 envelopes per package were used for randomization, one of which was selected by the samples.
Settings and conduct
Among pregnant women aged 26-28 weeks referring to selected comprehensive health centers in Esfahan who have the inclusion criteria, 70 people enter the study and are randomly assigned to one of the two intervention or control groups. In the intervention group, Neroli oil is inhaled in 12 one-hour sessions three times a week. The control group also receives routine pregnancy care. The mood states and resilience of the samples were measured before the study, immediately after the intervention and one month after the end and compared in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primary gravid and single fetus, gestational age 26-28 weeks with Iranian citizenship and primary and higher education; has a healthy sense of smell. Criteria for not entering: unwillingness and consent to participate in the study; history of allergies and eczema to known flowers and plants and aromatic substances; history of respiratory diseases, psychiatric diseases, hypertension, headache and migraine; unwanted pregnancy; having any midwifery problems during pregnancy that require absolute rest or taking certain medications; using all kinds of complementary and alternative medicine methods during the last month.
Intervention groups
In the aromatherapy group, Neroli oil is inhaled in 12 one-hour sessions three times a week. The control group also receives routine pregnancy care
Main outcome variables
Mood states; resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130525013449N3
Registration date:2021-10-29, 1400/08/07
Registration timing:registered_while_recruiting
Last update:2021-10-29, 1400/08/07
Update count:0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2937
Email address
fahami@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on mood states and resilience of pregnant women
Public title
The effect of aromatherapy on mood states and resilience of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primary gravid and single fetus
Gestational age 28-26 weeks
Having Iranian citizenship
Primary and higher education
Have a healthy sense of smell
Exclusion criteria:
Unwillingness and consent of the mother to participate in the study
History of allergies and eczema to known flowers and herbs and aromatic substances
History of respiratory diseases such as asthma
psychiatric illness
Having any obstetric problems during pregnancy that require absolute rest or taking certain medications
Unwanted pregnancy
Using a variety of complementary and alternative medicine methods during the past month
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using two numbered envelopes (envelope number one for the intervention group and envelope number two for the control group) and selecting an envelope by research samples)
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
The deputy of Research and Technology, Building No. 4, Esfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.119
Health conditions studied
1
Description of health condition studied
Normal pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy
Primary outcomes
1
Description
Mood States Score in POMS Mood States Questionnaire
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
POMS Mood States Questionnaire
2
Description
Resilience score
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aromatherapy with Neroli essential oil three times a week for a month (12 times in total) by pouring 5 drops of essential oil on a handkerchief each time and attaching it to their collar. Then breathe normally for an hour, then remove the handkerchief. The essential oil is used by Blue Moon brand and with a concentration of one percent
Category
Behavior
2
Description
Control group: The control group receives routine prenatal care