Protocol summary

Summary
This study determining effect of lavender aromatherapy on the pain level after cesarean section among women referred to Al-Zahra Hospital in Rasht during 2016- 2017.This study is a double blind clinical trial on pregnant women. Inclusion criteria: pain VAS score higher than 3; using spinal anesthesia; use of a type of anesthetic(bupivacaine 0.05); no concurrent operation; duration of operation less than 90 min; full term pregnancy; no history of allergies to medicinal plants, anosmia, migraines, chronic headaches, coagulation disorders, polyhydramnios, diabetes, preeclampsia, twin pregnancy. Exclusion criteria: nausea, vomiting; allergy or absence of patients satisfaction after first dose of aromatherapy. The Samples was selected from mothers who will refer to the hospital for C-section surgery will be divided, based on the table of randomized block design, into two groups of A and B, each composed of 55 people. The experimental group will be treated with Lavender essence in three phases, and the control group will receive placebo with identical arrangements. The pain of patients before and after intervention will be evaluated by VAS. The first evaluation by VAS will be performed 4 hours after the surgery. In the experimental group, 5 drops (100%) lavender essence will be applied on a cotton swab and the swab will be placed for 3 minutes in the oxygen mask ; 30 minutes after removing the swab, a second pain evaluation will be performed. Second and third phases of test will be similar to the first phase (6 and 12 hours after the surgery).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072529063N1
Registration date: 2016-09-19, 1395/06/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-19, 1395/06/29
Registrant information
Name
Sedigheh Pakseresht
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 331 5015
Email address
paksersht@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Faculty of Nursing & Midwifery
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey effect of lavender aromatherapy on the pain level after cesarean section among women referred to Al-Zahra hospital in Rasht in 2016- 2017
Public title
Effect of lavender aromatherapy on the pain level after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pain VAS score higher than 3; using spinal anesthesia; use of a type of anesthetic(bupivacaine 0.05); no concurrent operation; duration of operation less than 90 min; full term pregnancy; no history of allergies to medicinal plants, anosmia, migraines, chronic headaches, coagulation disorders, polyhydramnios, diabetes, preeclampsia, twin pregnancy. Exclusion criteria: nausea, vomiting; allergy or absence of patients satisfaction after first dose of aromatherapy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo St., Shahid Beheshti Highway
City
Rasht
Postal code
39841-41469
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.GUMS.REC.1395.109

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain

Primary outcomes

1

Description
Pain
Timepoint
4, 8 and 12 hours after C-section(before and after intervention)
Method of measurement
Visual Analoge Scale

Secondary outcomes

1

Description
Respiratory rate
Timepoint
Before each intervention and after half an hour each intervention
Method of measurement
According to measurements by watches with counting the abdominal breathing

2

Description
Pulse rate
Timepoint
Before each intervention and after half an hour each intervention
Method of measurement
By measuring the watch has a second hand

3

Description
Blood pressure
Timepoint
Before each intervention and after half an hour each intervention
Method of measurement
Sphygmomanometer

Intervention groups

1

Description
In the experimental group, 5 drops (100%) lavender essence will be applied on a cotton swab and the swab will be placed for 3 minutes in the oxygen mask 4 hours after the surgery ; 30 minutes after removing the swab, a second pain evaluation will be performed. Second and third phases of test will be similar to the first phase (6 and 12 hours after the surgery
Category
Prevention

2

Description
control group: 5 drops of placebo will be applied on a cotton swab and the swab will be placed for 3 minutes in the oxygen mask
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Farnosh Farzie( Associate Prosessor and hospital administration)
Street address
Namjoo St., in front of Azodi Stadium, Rasht, Guilan, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Dr. Rasool Tabari
Street address
Vice Chancellor for Research and Technology, In front of Sepah Bank, Shahid Beheshti Boulevard West -
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Sedigheh Pakseresht
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo St., Shahid Beheshti Highway
City
Rasht
Postal code
39841-41469
Phone
+98 911 331 5015
Fax
+98 13 3355 0097
Email
paksersht@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Dr Sedigheh Pakseresht
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo St., Shahid Beheshti Highway
City
Rasht
Postal code
39841-41469
Phone
+98 911 331 5015
Fax
+98 13 3355 0097
Email
paksersht@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Dr Sedigheh Pakseresht
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo St., Shahid Beheshti Highway
City
Rasht
Postal code
39841-41469
Phone
+98 911 331 5015
Fax
+98 13 3355 0097
Email
paksersht@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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