The title of this research study is the effects of lavender aroma on intramuscular injection pain of magnesium sulfate in women with pre-eclampsia. The objective of the study is comparison of pain severity of injection between lavender oil and control groups.Sweet almond oil will be used in control group. The inclusion criteria of the study are need to magnesium sulfate injection, lack of respiratory disease and sensitivity to a material. If a participant cannot tolerate inhalation of lavender oil or control substance, she will be excluded from the study.Initially the researcher will make sure the need for injection of magnesium sulfate by checking the patient’s medical record. Participants will be selected considering the inclusion criteria of the study. The objectives of the study will be described to the patients and informed consent will be taken, then the participants will be assigned to lavender or control group using simple randomization method . Ten minutes before the injection of magnesium sulphate3 drops of 10% lavender oil will be added to several layers of tissue and the participant will put it 20 centimetre apart from her nose and breath naturally. For injection procedure the participant will be placed in the lateral position and 10 milliliter of 50% magnesium sulfate will be injected with the 90 degrees angle. Injection speed will be 1 milliliter per 10 seconds. Besides, other injection cares such as skin disinfection with an alcohol swap and patient privacy will be respected.The control group will be manage as the same manner described above with placebo material. Pain scores will be determined using a visual analog scale immediatly and 15 minutes after the injection.Due to special odor of essential oils, blinding of the study for the data collector and the participants is not possible. In addition, data analysis will be performed by the researcher. Finally, the data analyzed with proper statistical tests.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015031710327N12
Registration date:2015-07-07, 1394/04/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effects of lavender aroma on intramuscular injection pain of magnesium sulfate in women with pre-eclampsia
Public title
the effects of lavender aroma on intramuscular injection pain of magnesium sulfate in women with pre-eclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Willingness to participate in the study; the need to an intramuscular injection of magnesium sulphate according to the commandment of the physician; lack of any medical condition such as heart and respiratory disease or psychological disorder; lack of of sensitivity to a substance or drug; lack of any lesion in injection site (buttock)
exclusion criteria: Intolerance of inhalation of lavender oil or control substance during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Simple randomization will be performed via closed pockets.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Science Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.REC.1394.7
Health conditions studied
1
Description of health condition studied
Pain of intramuscular injection of magnesium sulfate
ICD-10 code
Y83-Y84
ICD-10 code description
Surgical and other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and After injection of magnesium sulfate
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 minutes before injection, the intervention group will inhale lavender oil (10%). Lavender oil will be provide in department of pharmacology in medical school .
Category
Prevention
2
Description
Control group: 10 minutes before injection, the control group will inhale sweet almond oil.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital and Zeinabieh hospital
Full name of responsible person
Farideh Vaziri
Street address
School of Nursing and Midwifery, Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for Reaserch of Shiraz Univercity of Medical Sciences
Full name of responsible person
Seied Basir Hashemi
Street address
Shiraz Univercity of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for Reaserch of Shiraz Univercity 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
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
roose82003@yahoo.com; vazirif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
roose82003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)