Protocol summary

Summary
The aim of the study is to evaluate the effect of Citrusaurantium Aroma on severity of labor pain and anxiety in patients admitted to Vali-e Asr h Hospital, Touyserkan County, Iran in 2013. Inclusion Criteria: be Iranian; be nulliparous; be at the age of 18-35 years old; have a singleton term pregnancy; fetal presentation should be vertex; onset of contractions should be spontaneous, and at the beginning of admission, have a 3 to 4-cm dilatation; appropriate pelvic position; estimated fetal weight should range from 2500 to 4000 gr; amniotic sac should be sound when admitting to the study; over the past 8 hours, mother have not used analgesic medicines; have no known liver, gallbladder, and respiratory disease records in her file; according the file, have no complication during pregnancy such as pre-eclampsia, bleeding and infection; according to her, have not olfactory problems; according to her, not sensitive to herbal medicines. Exclusion criteria: emergency cesarean before completing the study; sensitive to citrus scents and non-tolerance during the study term; obstetric complications such as vaginal bleeding during the study; analgesic intake during the study. The minimum sample needed in each of aromatherapy and placebo groups is 63 persons. In aromatherapy group, 4 ml of citrus aurantium is used. Aromatherapy begins from dilatation of 3-4 cm, and severity of labor pain is measured 20 min after aromatherapy, after which aromatherapy continues until delivery time. In aromatherapy group, 4 ml of citrus scents is stained with gas and attached to the collar of the patients. Every half hour, the prescription will be repeated. In control group, 4 ml of normal saline is stained with gas, and every half hour, this is repeated. Severity of labor pain and anxiety before and after intervention in 3-4, 5-7, and 8-10 dilatations is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301306807N6
Registration date: 2013-07-17, 1392/04/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-17, 1392/04/26
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research Dept, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-04-22, 1392/02/02
Expected recruitment end date
2014-01-22, 1392/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Effect of Citrus aurantium Aroma on Severity of Labor Pain and Anxiety in Patients Admitted to Vali-e Asr Hospital, Touyserkan County in 2013
Public title
Study of Effect of Citrus aurantium Aroma on Severity of Labor Pain and Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: be Iranian; be nulliparous; be at the age of 18-35 years old; have a singleton term pregnancy; fetal presentation should be vertex; onset of contractions should be spontaneous, and at the beginning of admission, have a 3 to 4-cm dilatation; appropriate pelvic position; estimated fetal weight should range from 2500 to 4000 gr; amniotic sac should be sound when admitting to the study; over the past 8 hours, mother have not used analgesic medicines; have no known liver, gallbladder, and respiratory disease records in her file; according the file, have no complication during pregnancy such as pre-eclampsia, bleeding and infection; according to her, have not olfactory problems; according to her, not sensitive to herbal medicines. Exclusion criteria: emergency cesarean before completing the study; sensitive to citrus scents and non-tolerance during the study term; obstetric complications such as vaginal bleeding during the study; analgesic intake during the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 126
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
Shahid Beheshti University of Medical Sciences and health services
Street address
Shahid Beheshti University of Medical Sciences,Velenjak Street, Shahid Chamran High Way, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
400/634

Health conditions studied

1

Description of health condition studied
childbirth pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

2

Description of health condition studied
anxiety of childbirth
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
intensity of pain
Timepoint
before and after intervention in 3-4, 5-7, and 8-10 dilatations
Method of measurement
Numeric Rating scale Ruler

2

Description
anxiety
Timepoint
before and after intervention in 3-4, 5-7, and 8-10 dilatations
Method of measurement
Speilberger checklist

Secondary outcomes

empty

Intervention groups

1

Description
In aromatherapy group, 4 ml of citrus scents is stained with gas and attached to the collar of the patients. Every half hour, the prescription will be repeated.
Category
Treatment - Drugs

2

Description
In control group, 4 ml of normal saline is stained with gas, and every half hour, this is repeated.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital in Tuyserkan city
Full name of responsible person
Street address
City
Tuyserkan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research Dept of School of Nursing and Midwifery Shahid Beheshti University of M
Full name of responsible person
Dr Masoumeh Simbar
Street address
School of Nursing and Midwifery, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Vali-e Asr Ave., Tehran
City
Tehran
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 Dept of School of Nursing and Midwifery Shahid Beheshti University of M
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
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Namazi
Position
Master student of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Vali-e Asr Ave., Tehran
City
Tehran
Postal code
Phone
+98 81 1825 5724
Fax
Email
masnamazi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery; Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddighe Amir Ali Akbari
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Vali-e Asr Ave., Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
sedaliakbari@gmail.com; akbarisedd@sbmu.ac.ir; asa_akbari@yahoo.com
Web page address

Person responsible for updating data

Contact

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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