This study is a single blind randomized clinical trial two-group that will do in order to effect of Salvia Officinalis aroma on Labor Pain and anxiety on 160 pregnant women who were referred to the Moatazedi hospital in Kermanshah. Inclusion criteria: gestational age 42-38 weeks; with a singleton live fetus and cephalic presentation; Examination of cervical dilatation on arrival 4-3 cm; without any medical problems or complications of pregnancy and mental illness. The exclusion criteria were: mother's unwillingness to continue to participate in the study; occurrence of any difficulties during the study. Before intervention Visual Analogue Scale and Spielberger scale were completed by both groups, pain and anxiety scores are determined. In the intervention group three drops of Salvia Officinalis fragrance were poured on a cotton and is connected to the cloths collar of samples and it repeated every half hour. The control group received aromatherapy via a similar method, using three drops of normal saline. After the intervention, anxiety in 5-7 dilatation and pain in dilatations of 3-4, 5-7 and 8-10 cm is measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042727633N1
Registration date:2016-05-15, 1395/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Assistance of research Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Salvia Officinalis aroma on severity of Labor pain and anxiety
Public title
Effect of Salvia Officinalis aroma on severity of Labor pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
nclusion criteria: gestational age 42-38 weeks; with a singleton live fetus and cephalic presentation and approved by ultrasound; Examination of cervical dilatation on arrival 4-3 cm; without any medical problems or complications of pregnancy and mental illness; lack of respiratory diseases and allergies; having tested positive smell; lack of drug addiction and alert in time and place. The exclusion criteria were: mother's unwillingness to continue to participate in the study; occurrence of Any difficulties during the study(such as cord prolapse; placental abruption; preeclampsia , etc.); receive analgesic 3 hours before the intervention and decreaseof consciousness.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Kermanshah University of Medical Sciences
Street address
Boulevard martyr Beheshti University of Medical Sciences Building Number One
City
Kermanshah
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.168
Health conditions studied
1
Description of health condition studied
Abdominal and pelvic pain
ICD-10 code
R10.3
ICD-10 code description
pain localized to other parts of lower abdomen
2
Description of health condition studied
Anxiety
ICD-10 code
f41.9
ICD-10 code description
anxiety disorder unspecified/anxiety NOS
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, and at 7-5 cm dilatation
Method of measurement
Scale (STAI)
2
Description
pain
Timepoint
Before the intervention and dilatations of 3-4, 5-7 and 8-10 cm
Method of measurement
VAS
Secondary outcomes
1
Description
Apgar of newborn
Timepoint
The first and fifth minutes after birth
Method of measurement
Scale five of determination of Apgar
2
Description
time of first Stage of Labor
Timepoint
In dilatation of 4-3, 7-5 and 10-8 cm
Method of measurement
duration and interval of conteractions, dilatation and effacement of cervix
Intervention groups
1
Description
In the intervention group three drops of Salvia Officinalis fragrance were poured on a cotton and is connected to the cloths collar of samples and it repeated every half hour
Category
Treatment - Drugs
2
Description
In the contorol group three drops of normalsalin were poured on a cotton and is connected to the cloths collar of samples and it repeated every half hour
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Moatazedi hospital in Kermanshah
Full name of responsible person
Frozan sharifipour
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azam bakhteh
Street address
Dolat abad
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Frozan sharifipour
Position
MSc
Other areas of specialty/work
Street address
Dolat abad
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
sharifipour_fr91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Azam bakhteh
Position
MSc
Other areas of specialty/work
Street address
Dolat abad
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
bakhteh_a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Frozan sharifipour
Position
MSc
Other areas of specialty/work
Street address
Dolat abad
City
Kermanshah
Postal code
Phone
+98 83 3827 5239
Fax
Email
sharifipour_fr91@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)