The aim of study was to evaluate the effects of essential oil aromas of Lemon verbena (Lippia citriodora) on amount of anxiety and physiologic indicators of patients before Cesarean Surgery at Alzahra hospital in the city of Rasht in 1395 in a randomized clinical trial. Inclusion criteria included: Iranian nationality; full consciousness; the ability to read and write and smell; a hemodynamic stability; lack of emergency caesarean section; no history of surgery other than caesarean section and no history of hospitalization or other medical care due to mental disorders. Exclusion criteria: history of allergy to fragrances of lemon. The minimum required sample size in each groups are 42 people. In the aromatherapy group; 3 drops of essential oil of Lemon verbena leaves are used in this manner; a cotton ball will be dipped with three drops of essential oil, then put it into jars with lids. Applicants will be given to each group a jar. The volunteers be asked to open the jar’s door and kept it 10-7 cm from their nose and breathe normally for 20 minutes. Anxiety is measured 20 minutes after aromatherapy. In the Control group will be used 3 drops of distilled water and according to the former method will be given to the patient, and then measured the intensity of anxiety after 20 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073116325N4
Registration date:2016-09-08, 1395/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Katayoun Haryalchi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
haryalchi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research-Guilan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of essential oil aromas of Lemon verbena (Lippia citriodora) on anxiety and physiologic indicators of patients before Cesarean Surgery
Public title
The effects of essential oil aromas of Lemon verbena (Lippia citriodora) on anxiety and blood pressure,respiratory and heart rate of patients before Cesarean Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria including: Iranian nationals; complete intelligence; the ability to read and write and smell; a hemodynamic stability; lack of emergency cesarean section; no history of surgery other than caesarean section; non-smoker; no alcohol or drugs; non-use of benzodiazepines for a week before the surgery; no history of allergic rhinitis (pharmaceutical, seasonal or oral) or respiratory problems and no history of hospitalization or other medical care due to mental disorders.
Exclusion criteria: history of allergy to fragrances of lemon
Age
From 14 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Giulan university of medical sciences Ethics committee
Street address
Vice chancellor for research and technology- above the iran radiator representation- opposite sepah bank- western martyr Beheshti boulevard- gas square-Rasht-Guilan
City
Rasht
Postal code
41938-93345
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.GUMS.REC.1395.104
Health conditions studied
1
Description of health condition studied
Maternal distress during labour and delivery
ICD-10 code
O75.0
ICD-10 code description
Other complications of labour and delivery, not elsewhere classified
Primary outcomes
1
Description
The effects of essential oil aromas of Lemon verbena (Lippia citriodora) on anxiety and physiologic indicators of patients before Cesarean Surgery.
Timepoint
20 minute after intervention
Method of measurement
Anxiety spielberger questionnaire
Secondary outcomes
1
Description
The average systolic blood pressure
Timepoint
20 minute after intervention
Method of measurement
Mercurial manometer
2
Description
Respiratory rate
Timepoint
20 minute after intervention
Method of measurement
Analog clock
3
Description
Heart rate
Timepoint
20 minute after intervention
Method of measurement
Analog clock
Intervention groups
1
Description
In aromatherapy group three drops of essential oils of Lemon verbena leaves will be used.and three drops of essential oils on a cotton ball shed, then put it in to jars with lids. to each volunteer entrance to each group a jar will be given. The volunteer were asked to open the door of jars and keep it 10-7 cm from their nose and breathe normally for 20 minutes. The amount of Anxiety will be measured 20 minutes after that.
Category
Treatment - Drugs
2
Description
In control group three drops of distilled water will be used on a cotton ball shed, then put it into jars with lids. to each volunteer entrance to each group a jar will be given. The volunteer were asked to open the door of jars and keep it 10-7 cm from their nose and breathe normally for 20 minutes. The amount of Anxiety will be measured 20 minutes after that.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Azzahra hospital
Full name of responsible person
Katayoun Haryalchi
Street address
Azzahra hospital- Namjo street- Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology-Guilan University of Medical Sciences
Full name of responsible person
Dr. Shadman Nemati
Street address
Vice chancellor for research and technology- above the iran radiator representation- opposite sepah bank- western martyr Beheshti boulevard- gas square-Rasht-Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology-Guilan 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
Name of organization / entity
Para medical college- Guilan university of medical sciences
Full name of responsible person
Masoumeh Fotouhi
Position
Anesthesia student
Other areas of specialty/work
Street address
Para medical college- martyr yaghoob sheikhi street-Leyla kuh road- Langerud-Guilan
City
Langerud
Postal code
Phone
+98 13 4253 6262
Fax
+98 13 4253 7171
Email
atefe.fotuhi@gmail.com
Web page address
www.gums.ac.ir/para
Person responsible for scientific inquiries
Contact
Name of organization / entity
Para medical college- Guilan university of medical sciences
Full name of responsible person
Masoumeh Fotouhi
Position
Anesthesia student
Other areas of specialty/work
Street address
Para medical college- martyr yaghoob sheikhi street-Leyla kuh road- Langerud-Guilan
City
Langerud
Postal code
Phone
+98 13 4253 6262
Fax
+98 13 4253 7171
Email
atefe.fotuhi@gmail.com
Web page address
www.gums.ac.ir/para
Person responsible for updating data
Contact
Name of organization / entity
Para medical college- Guilan university of medical sciences
Full name of responsible person
Masoumeh Fotouhi
Position
Anesthesia student
Other areas of specialty/work
Street address
Para medical college- martyr yaghoob sheikhi street-Leyla kuh road- Langerud-Guilan
City
Langerud
Postal code
Phone
+98 13 4253 6262
Fax
+98 13 4253 7171
Email
atefe.fotuhi@gmail.com
Web page address
www.gums.ac.ir/para
Sharing plan
Deidentified Individual Participant Data Set (IPD)