Aims: The overall purpose: the rosa damascena effect on pain and anxiety in first stage of labor in nulliparous women. specific objectives: 1. The pain of the first stage of labor in nulliparous women in both groups aromatherapy whit rosa damascena and the control group (normal saline). 2. to comper of pain in First stage of labor in nulliparous women in the two groups (Rose oil) and control (normal saline) 3. The anxiety of the first stage of labor in nulliparous women in both groups aromatherapy whit rosa damascena and the control group (normal saline). 4. to comper of anxiety in First stage of labor in nulliparous women in the two groups (Rose oil) and control (normal saline) Before starting work on demographic and obstetric, STAI anxiety questionnaire to be completed by the subjects described the pain is and how to use a ruler. Beginning of the active phase dilatation 4 cm aromatherapy with essential oils of Rose starts and continues until delivery. In this study, both times in aromatherapy 08/0 ml 2 drops of rose essential oil is applied to the gas sample is connected to clothes. In the control group 08/0 ml saline soaked gauze dress samples to be connected. This is repeated every half hour in both groups. 3 times the pain involved in dilatation of 5-4 cm, 7-6 cm and 10-8 cm, ten minutes after the inhalation of essential oils rose at the end of each contraction is measured, then compared the two groups intervention research results will be achieved. Instruments used in this study included demographic characteristic and obstetric instruments, observation and examination Czech lists, numeric pain rating scale and the Spilberger anxiety questionnaire.
General information
Acronym
Rosa Damascena
IRCT registration information
IRCT registration number:IRCT201306258801N3
Registration date:2013-07-28, 1392/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-28, 1392/05/06
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University for Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rosa Damascena effect on pain and anxiety in first stage of labor in nulliparous women
Public title
Rosa Damascena effect on pain and anxiety in first stage of labor in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Characteristics of the subjects (inclusion criteria): The Iranian women, primigravida, who are aged between 18 and 35 years, with term pregnancy; singleton fetuses with vertex views are being studied. The onset of spontaneous contraction and dilation of the examination on arrival, 4-3 cm, at the right hip; the mother of 8 hours is not taking analgesic medications; have no pregnancy complications such as preeclampsia, gestational diabetes and obstetric complications such as decolman, previa abnormal fetal heart rate at baseline are known gastrointestinal disease, respiratory ... according to their own records and do not have an allergy to herbal and have no problem with the smell. Exclusion criteria: completion of previous emergency caesarean; withdrew from the partnership before the completion of the study.
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:
120
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
shaied Beheshti University of Medical Sciences, Tehran
Street address
School of Nursing and Midwifery Niayesh Croos Vali Asr Tehran
City
Tehran
Postal code
Approval date
2013-06-15, 1392/03/25
Ethics committee reference number
1392-1-86-11354
2
Ethics committee
Name of ethics committee
shaied Beheshti University of Medical Sciences, Tehran
Street address
School of Nursing and Midwifery Niayesh Croos Vali Asr Tehran
City
tehran
Postal code
Approval date
2013-06-15, 1392/03/25
Ethics committee reference number
1392-1-86-11354
Health conditions studied
1
Description of health condition studied
Pain and anxiety in first stage of labor
ICD-10 code
O60-75
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
Labor pain in active phase
Timepoint
Before intervention, three times after intervention in dilataions 4 to 5 cm, 6 cm to 7, 8 to 10 cm
Before intervention, twice after intervention in dilatasions of 4 to 5 cm, 8 to 10 cm
Method of measurement
STAI anxiety questionnaire
Secondary outcomes
1
Description
Nausea
Timepoint
After intervention hourly untill the end of intervention
Method of measurement
View with questions
Intervention groups
1
Description
Intervention group: Essence of Rosa damascena inhaled in the active phase of labor, ie the dilatation of 4 cm to 10 cm for women nulliparous be the case that every half-hour, two drops of oil equivalent 0/08 cc of the gas thread is poured heavily pain and anxiety after the intervention of certain dilation is measured.
Category
Placebo
2
Description
The control group received placebo or placebo (normal saline) instead of oil used. Occurs because of the active phase of labor, ie the dilatation of 4 cm to 10 cm for women nulliparous be the case that every half-hour, two drops of normal saline, which is equivalent to 0/08 cotton cc gas is poured on pain and anxiety after the intervention of certain dilation is measured
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Javadol Aemmeh hospital, Jajarm city
Full name of responsible person
Street address
City
Jajarm
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shaied Beheshti University of Medical Sciences
Full name of responsible person
Mr Dr mahammad rahmati rodsari
Street address
Research- Shaied Beheshti University of Medical Sciences – Taleghani St. - Tabnak St.- Evin Chamran Highway -Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shaied Beheshti 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
Shaied Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoomeh Simbar
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery Niayesh Croos Vali Asr Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2517
Fax
Email
msimbar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaied Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoomeh Simbar
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery Niayesh Croos Vali Asr Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2517
Fax
Email
msimbar@ yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaied Beheshti University of Medical Sciences
Full name of responsible person
Sepide Hamdamian
Position
MSc Midwifery student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Niayesh Croos Vali Asr Tehran
City
Tehran
Postal code
Phone
+98 21 8865 5365
Fax
Email
hamdamian.sepide@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)