Aim of this study is to determine the effect of lavender aromatherapy on anxiety of primiparous women during first stage of labor. This study is an interventionl study in two groups (exam and control group) with pre-test and post-test. Study population are pregnant women referred to the physiologic delivery center in Fatemieh hospital in Hamadan city. A sample of 35 people in the intervention group and 35 people in the control group has been determined. The samples will be selected randomly with six blocks (ABBABA) method. Then, the researcher will measure state and trait anxiety by Spielberger questionnaire in two groups (intervention and control groups) . Researcher will be poured a drop of lavender oil with concentration of 2% (under the supervision of pharmacist) on fabric napkins. Napkins will attach with pin to patient' dress collar. Then they will be requested to be breath normally for 15 minutes.The questioner will be measure state and trait anxiety for three times 15, 60 and 90 minutes after intervention. Finally two groups will be compared on anxiety during first stage of labor using descriptive and inferential statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072310426N12
Registration date:2016-07-28, 1395/05/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-28, 1395/05/07
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on anxiety of primiparous women during first stage of labor
Public title
The effect of lavender aromatherapy on anxiety of primiparous women during first stage of labor In Fatemieh Hospital Hamadan city
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: mothers'age between 18-35 years; Single fetus pregnancy; Gestational age 42-37 weeks; Cervical dilation between 5-3 cm; Lack of obstetric complications in pregnancy; important medical disorders ; and no history of psychological problems.
Exclusion criteria: The incidence of allergy symptoms in the mother; Precipitate delivery; cesarean section.
Age
From 18 years old to 35 years old
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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences- ShahidFahmideh Street- Counterpoint of Mardom Park
City
Hamadan
Postal code
65178
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.UMSHA.REC.1395.83
Health conditions studied
1
Description of health condition studied
Aromatherapy with lavender on anxiety in labor ; Pregnancy-related condition, unspecified
ICD-10 code
O75.9
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
State and trait anxiety
Timepoint
15, 60 and 90 minutes after the intervention
Method of measurement
Standard Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group: After obtaining written testimonial from people, The samples will be selected by randomization blocks with six blocks (ABABA) method to two experimental and control groups. Lavender essential oil produced from BarijEsanse company will give to mothers in the intervention. Researcher will be poured a drop of lavender oil with concentration of 2% (under the supervision of pharmacist) on fabric napkins. Napkins attach with pin to dress collar, Then Will be requested from mother breathing normally for 15 minutes. Researcher will be measured and recorded apparent and hidden anxiety in the experimental group before and after 15, 60 and 90 minutes after the intervention by Spielberger State and Trait questionnaire (STAI).
Category
Treatment - Drugs
2
Description
In control group: Mothers in the control group to be delivered placebo (water) in a bottle as same as intervention group . Research assistant will be poured a drop of placebo (water) on fabric napkins for mothers in the control group. Napkins attach with pin to dress collar, Then Will be requested from mother to breathing normally for 15 minutes. Researcher will be measured and recorded apparent and hidden anxiety in the experimental group before and after 15, 60 and 90 minutes after the intervention by Spielberger State and Trait questionnaire (STAI).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemih Hospital
Full name of responsible person
Mahtab Satari
Street address
Shahid Zamani, Fatemih Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
ShahidFahmideh Street- Counterpoint of MardomParkHamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsh.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)