The title of this study is"The effect of lavender aromatherapy on pain of pentavalent vaccination.
Background and aim: It is well- known that the fetus and infant can respond to pain stimulus. Therefore, vaccination is a painful procedure in infants. Different methods like kangaroo care were applied to reduce vaccination pain in infants but, inhalation aromatherapy was considered less than other methods. The objective of this study is to assess effectiveness of inhalation aromatherapy on pain due to penatvalent vaccination in infants. Inclusion criteria included: parents’ willingness to participate their infants; infants with term birth (37-42 weeks); healthy and without any congenital anomaly infants.
Methods: in the centers for vaccination, infants who need to pentavalent vaccination are assigned to lavender group or control group (sweet almond oil group) randomly. Infants will be placed on vaccination bed and baseline pain assessment will fill out for them. Then, using a sterile 4 by 4 gauze pad with 3- 4 drops oil dripped on, inhalation aromatherapy will be started. Inhalation aromatherapy last 1 minute. Then, the vaccinator will inject the vaccine. Pain assessments will be done 15 seconds and 5 minutes after vaccination again. If the infant cannot tolerate the aromatherapy oils, the intervention will be discontinued immediately. This study is a double blind research. The research assistant that will collect the data are blind to materials of aromatherapy also. Furthermore, in this study 1% lavender oil will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072310327N14
Registration date:2016-08-03, 1395/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-03, 1395/05/13
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
2016-06-09, 1395/03/20
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on pentavallan vaccination
Public title
The effect of lavender aromatherapy on pain of pentavalent vaccination
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: parent’s willingness to participate their infants; infants with term birth (37-42 weeks); healthy infants; infants without any congenital anomaly.
exclusion criteria: Intolerance of inhalation of lavender oil or control substance during the study and infants with persistent crying before intervention
Age
From 2 months old to 4 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.REC.1394.204
Health conditions studied
1
Description of health condition studied
Pain due to vaccination
ICD-10 code
T79
ICD-10 code description
Certain early complications of trauma, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Before, 15 seconds and 5 minutes after intervention
Method of measurement
Infants pain assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: inhalation aromatherapy by 1% lavender oilwill be used, 3-4 drops in a 4 by 4 gauze pad from one minute before vaccination. this pad will be place next to infant's head.
Category
Prevention
2
Description
Control group: 3-4 drops of sweet almond as placebo will be used in this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadi Health Center
Full name of responsible person
Zahra Ghosropoor
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz University 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
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Vaziri
Position
MSc
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Phone
+98 71136474254
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
MSc
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Phone
+98 71136474254
Fax
Email
roose82003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciensces
Full name of responsible person
Farideh Vaziri
Position
MSc
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Phone
+98 71136474254
Fax
Email
roose82003@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)