Protocol summary

Summary
Objectives: This study compared the effects of aromatherapy geranium and orange essential oil in first stage of labor in nulliparous on the anxiety and vital sign.Design: parallel. Setting and conduct: This study is a three-group of randomized clinical trial. The sample consisted of 150 nulliparous admitted to the Bojnoord Bint al-Huda hospital. After take consent of the participants were randomly divided into 3 groups. One group would receive geranium essential oil (50) and orange oil group (50) and a distilled water (50).Before and 20 minutes after intervention are examined to STAI anxiety questionnaire, physiological parameters would record. Participants including: Inclusion criteria for this study included nulliparous women to full-term pregnancy, with a single fetus, cervix dilatation of 3-5cm,haven't chronic disease, no colds and haven't nasal congestio, anosmia, lack of sensitivity to smell specific experience of breath smells particular (which bad recalls memories or stress), the use of sedatives or anti-anxiety in 3 hours before the experiment, no known mental illness, no history of epilepsy and asthma, lack of fetal distress, failure to induce labor there was a high risk pregnancy. Exclusion criteria for the study, the firm's unwillingness to continue the study of fetal distress or impairment in labor progress during the intervention, use of pain medication during labor induction or intervention. Intervention: One group, orange essential oil 2% and other group geranium oil 2% and in control group distilled water 2drops would receive on non-absorbent fabric, the clothing will connect. Main outcome measures Intervention. Anxiety, physiological parameters, including systolic blood pressure, diastolic blood pressure, respiration and pulse.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012111811515N1
Registration date: 2013-09-15, 1392/06/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Fahimeh Rashidi Fakari
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 4224 6095
Email address
rashidif85@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical Sciences of Vice chancellor for research, North Khorasan University
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of geranium (pelargonium graveolens) and orange (citrus sinesis) aroma on anxiety and vital signs in first stage of labor in primiparous women
Public title
The effect of aromatherapy on anxiety and vital signs
Purpose
Prevention
Inclusion/Exclusion criteria
included nulliparous women; full-term pregnancy (37-42); ages 18-35; with a single fetus; dilatation of3-5 cm ; haven't chronic disease; no colds and haven't nasal congestion; anosmia; lack of sensitivity to smell specific experience of breath smells particular (which bad recalls memories or stress); the use of sedatives or anti-anxiety in 3 hours before the experiment; no known mental illness; no history of epilepsy and asthma; lack of fetal distress; failure to induce labor there was a high risk pregnancy. Exclusion criteria for the study; the firm's unwillingness to continue the study of fetal distress or impairment in labor progress during the intervention; use of pain medication during labor induction or intervention
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Ethics Committee of North Khorasan University of Medical Sciences
Street address
20 Number, Berenji street, Bojnord, North Khorasan
City
Bojnord
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
91/p/349

Health conditions studied

1

Description of health condition studied
Anxiety Level
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
anxiety level of first phase of labor
Timepoint
Befor and 20 min after intervention
Method of measurement
Spielberger state-trait

Secondary outcomes

1

Description
pulse rate
Timepoint
Before and 20 minutes after intervention
Method of measurement
examination

2

Description
Systolic BP
Timepoint
Before and 20 minutes after intervention
Method of measurement
examination

3

Description
Diastolic BP
Timepoint
Before and 20 minutes after intervention
Method of measurement
examination

4

Description
pain intensity
Timepoint
Before and 20 minutes after intervention
Method of measurement
VAS pain scale

Intervention groups

1

Description
In test one (oil of orange peels) and experimental group II (Essence Geranium), on fabric, non-absorbent, the clothing connected. Before and 20 minutes after intervention anxiety inventory STAI, physiological parameters by examining pain Pain was measured using visual analog scales.
Category
Prevention

2

Description
In the control group, distilled water onto non-absorbent fabric, the clothing connected. Before and 20 minutes after intervention STAI anxiety questionnaire, physiological parameters were recorded by the examiner and VAS pain scale.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bentul Hoda Hospital Bojnourd, Bojnourd, North Khorasan
Full name of responsible person
Alieh Mortazavi
Street address
Bentul Hoda Hospital Bojnourd, Zaieshgah Street , Bojnourd, North Khorasan
City
Bojnourd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical Sciences of Vice chancellor for research, North Khorasan University
Full name of responsible person
Arash Aabri
Street address
20 Number, Berenji street, Bojnord
City
Bojnord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences of Vice chancellor for research, North Khorasan University
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
North Khorasan University of Medical Sciences
Full name of responsible person
Maboobeh Tabatabaee Chehr
Position
Mentor, Msc of midwifery
Other areas of specialty/work
Street address
Bojnourd,Shahriar street ,Faculty Nursing & Midwifery Of Bojnourd
City
Bojnourd
Postal code
Phone
+98 85 4229 7095
Fax
Email
chehr19@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi Fakari
Position
Msc of Midwifery
Other areas of specialty/work
Street address
3 Number, ferdwsi 3 street, Bojnourd, North Khorasan
City
Bojnord
Postal code
Phone
+98 58 4232 1812
Fax
Email
fahimehrashidi85@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi Fakari
Position
Msc of midwifery
Other areas of specialty/work
Street address
3 Number, 3 ferdwsi street, Bojnourd, North Khorasan
City
Bojnourd
Postal code
Phone
+98 58 4232 1812
Fax
Email
fahimehrashidi85@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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