It's estimated that up to 40% of all infants have colic. An infant with colic may affect family stability and be a cause of short-term anxiety or depression in the mother. It may also contribute to exhaustion and stress in the parents. This study aimed to assess effectiveness of lavender oil aromatherapy on infantile colic. Inclusion criteria included: parent’s willingness to participate their infants, physician diagnosis for infantile colic, without any medical problem, aged 4-8 weeks, and no chemical drug consumption for colic.
Methods: in pediatrics clinics, infants who need to treat colic are assigned to lavender group or control group (sweet almond oil group) randomly. Mothers of the infants will be trained to use the aromatherapy oils twice a day for 6 days, three days inhalation and following three days apply to abdominal skin. Using a sterile 4 by 4 gauze pad with 3- 4 drops of oil dripped on, inhalation aromatherapy will be performed for 15- 20 minutes. The gauze pad will be put next to infant’s head. Change in colic will be assessed by phone to mothers twice a day according to a self constructed check list by the researcher. If the infant cannot tolerate the aromatherapy oils, the intervention will be discontinued immediately. This study is a double blind research. The parents and also research assistant that will collect the data are blind to materials of aromatherapy. Furthermore, in this study 1% lavender oil will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072410327N15
Registration date:2016-09-01, 1395/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-01, 1395/06/11
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
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender oil aromatherapy on infantile colic
Public title
The effect of lavender oil aromatherapy on infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: parent’s willingness to participate their infants; physician diagnosis for infantile colic; without any medical problem; aged 4-8 weeks, and no chemical drug consumption for colic.
exclusion criteria: Intolerance of aromathrapy oil during the study
Age
From 1 month old to 3 months old
Gender
Both
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)
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
Zand street
City
Shiraz
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.186
Health conditions studied
1
Description of health condition studied
Colic in infants
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Crying duration
Timepoint
before intervention and days1, 2,3,4,5, and 6 after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Lavender aromatherapy twice a day for 6 days
Category
Treatment - Other
2
Description
control group: Sweet almond aromatherapy as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza pediatrics clinc
Full name of responsible person
Zahra Sahebkram
Street address
Zand street
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
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
MS
Other areas of specialty/work
Street address
Zand street
City
Shiraz
Postal code
Phone
+98 71136281497
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
MS
Other areas of specialty/work
Street address
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
MS
Other areas of specialty/work
Street address
Zand street
City
Shiraz
Postal code
Phone
+98 71 1235 7282
Fax
Email
vazirif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)