Protocol summary

Summary
Objective: to determine the effect of lavender essential oil on the length of gestation in nulliparous women with late preterm labor. Design: clinical trial that is triple-blind, three-group and multicenter. Researcher at first after taking confirmation of the university ethics committee and provide a referral to hospital officials Imam Reza, Ghaem and Omolbanin (Mashhad, Iran), and permission to enter the gynecology ward. Samplers of primiparous women who were admitted with a diagnosis of late preterm delivery by inhibiting contractions that are ready to be discharged from the hospital, have the desire to participate in the study and the conditions of entry will be done. Since would be first pilot study, Since would be first pilot study, 30 cases in the intervention group and the control group with the placebo and control group without the intervention will be studied. For all groups, demographic questionnaire and pregnancy and recording of patient records and Spielberg questionnaire will be completed. Almond oil and lavender oil was used as placebo and medicine respectively. Pure essential oils of lavender product by Barij Essence(Kashan, Iran) that is diluted by pharmacist with 1 in 9 ml almond oil. The use of the drug in the abdomen and the 3 drops and three times a day. The researcher will teach women how to use. During the study, information daily by women will be collected by a questionnaire. During the study, researchers will follow up women twice a week. The data will be examined spss software. Inclusion criteria: first pregnant women; living in Mashhad city; gestational age based on ultrasound of the first quarter or the first day of the last menstrual period the first quarter 34- 36 weeks and 6 days; late preterm labor diagnosis; tend to participate in the study; aged between 18 and 35 years old; no specific illness; healthy amnion sac; no fever tend to be Iranian; have literacy; have singleton pregnancy; not having fetal distress; not having a ban on the use of aromatherapy, such as asthma, allergies; not having abnormalities of the uterus and fetus on ultrasound during pregnancy; not having a horrible event the last 6 months. Exclusion criteria during the study: sensitivity to be lavender essential oil; unwillingness to continue taking the drug by patients who are complications such as severe disability, or at least a continuous weeks or more than 3 days of medication per week; have fever(oral temp ≥38 ° C). Sample size in the final will be 60 cases.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051422280N1
Registration date: 2015-09-15, 1394/06/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-15, 1394/06/24
Registrant information
Name
Zainab Bolghanabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4222 4823
Email address
bolghanabadiz911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-20, 1394/01/31
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of lavender on duration of pregnancy in primigravida women with late preterm labor
Public title
Effect of essential oil of lavender on duration of pregnancy in primigravida women with late preterm labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: first pregnancy; living in Mashhad city, Iran; gestational age based on the first day of the last menstrual period or by Sonography be 34 – 36.6 weeks; diagnosis of late preterm labor; the desire to participate in the study have; age between 18 to 35 years old; no specific disease; normal amniotic sac; no fever ( Temperature ≥38° C); have Iranian nationality; have literacy; singleton pregnancy; no fetal distress; no contraindications for aromatherapy such as asthma; during the last 6 months have been a horrible accident; no embryonic and fetal anomalies by ultrasound during pregnancy. Exclusion criteria: allergic to lavender essential oil; accidents happen during research; unwillingness to continue taking the drug by patients; complications such as severe disability, or at least a continuous weeks or more than 3 days of medication per week; have fever(oral temp ≥38 ° C).
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Shahid Fakouri Boulevard, between Shahid Javan and Shahid Al-Shahidi
City
Mashhad
Postal code
9177899191
Approval date
2015-05-14, 1394/02/24
Ethics committee reference number
research/931022/1/465

Health conditions studied

1

Description of health condition studied
Pereterm labor
ICD-10 code
O60.0
ICD-10 code description
Onset (spontaneous) of labour before 37 completed weeks of gestation

Primary outcomes

1

Description
Length of pregnancy
Timepoint
After intervention until delivery
Method of measurement
Medical records

Secondary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, and every day after intervention
Method of measurement
Visual analgous Scale

Intervention groups

1

Description
Control 1: sweet almond oil place the abdominal locally to 3 drops 3 times a day
Category
Placebo

2

Description
Intervention group: lavender essential oil diluted 1: 9 in Place of intervention: abdominal locally to 3 drops 3 times a day
Category
Treatment - Drugs

3

Description
Control 2: without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommol Banin Hospital
Full name of responsible person
Tara, Fatemeh
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th
City
Mashhad

2

Recruitment center
Name of recruitment center
Emam Reza Educational, Research and Treatment Center
Full name of responsible person
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad

3

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Nafise Saghafi
Street address
Ghaem Educational, Research and Treatment Centerbeginning of Ahmadabad Avenue
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Grant name
بودجه معاونت پژوهش و فناوري
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Bolghanabadi
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
bolghanabadiz911@mums.ac.ir; bolghanabadiz67@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Firoozi, Mahboube
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
FirooziM@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Bolghanabadi
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
bolghanabadiz911@mums.ac.ir; bolhanabadiz67@gmail.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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