The aim of this study was to evaluate the effectiveness of aromatherapy on the postoperative pain in children in a double blind placebo-controlled clinical trial we selected 96 children between hospitalized children in surgical unit, with 3-6 years old in ease way and divided randomly into three groups. Patient in group A were given inhalation aromatherapy with Rosa damascene mill and in group B, pelargonium graveolens and group C were given almond oil as a placebo, although children in each groups and researcher and analyzer were unknowable of kind of aroma. Inhalation aromatherapy used at the first time of child enter to ward as the 0 time and then at 3, 6, 9 and 12 hours afterward and common treatment to palliative pain were used in each three groups. 30 minutes after per time aromatherapy, the postoperative pain in children were evaluated with the Toddler Preschooler Postoperative Pain Scale. Data was statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030516850N1
Registration date:2014-05-06, 1393/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-06, 1393/02/16
Registrant information
Name
Motahare Sirousfard
Name of organization / entity
Isfahan University of Medical Scencie, Nursing and Midvifry Faculty
Country
Iran (Islamic Republic of)
Phone
+98 31 1522 9759
Email address
msf222mmh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Rosa damascene mill and pelargonium graveolens on post operative pain intensity in hospitalized children
Public title
Effect of Aromatherapy in post operative pain in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 3-6 years old; hospitalized for surgery; both male and female; having many surgery slice; hospitalized in PI CU; not having any parents; having respiratory disease; used of narcotic or opiate in last week; having history of rhinitis or dermatitis in children or their parent; having chronic pain; used of complimentary medicine in last week.
Exclusion criteria: having no tendency to continues treatment; discharge or child died;having symptom of rhinitis or dermatitis; having infection symptom in surgical lesion; having symptom of illness in duration of study.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
3 groups (2 of interval groups and 1 control group) and 5 Times
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IsfahanUniversity of Medical Scencie
Street address
Isfahan University Medical Scencie, Hezar jreeb street
City
Isfahan
Postal code
Approval date
2013-06-20, 1392/03/30
Ethics committee reference number
1033
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
postoperative pain in children
Timepoint
0, 3, 6, 9 & 12 hourse after entire from operative room to ward
Method of measurement
Toddler Preschooler Postoperative Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
aromatherapy- Rosa damascena mill (intervention group 1) 1-2 drop in cotton pad, in 30 cm interval of child head
Category
Treatment - Other
2
Description
aromatherapy- pelargonium graveolens (intervention group 2) 1-2 drop in cotton pad, in 30 cm interval of child head
Category
Treatment - Other
3
Description
aromatherapy- almond oill (placebo)-(control group) 1-2 drop in cotton pad, in 30 cm interval of child head
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
F. Samouie (RN)
Street address
Emam Khomeini street
City
Isfahan
2
Recruitment center
Name of recruitment center
alzahra Hospital
Full name of responsible person
mansouri (RN)
Street address
shohadaye Soffe
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Scencie
Full name of responsible person
Dr. Peyman Adibi
Street address
Isfahan University of Medical Scencie ,Hezarjreeb street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Scencie
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
Isfahan University of Medical Scencie, Nursing and Midvifry Faculty
Full name of responsible person
Motahareh Sirousfard
Position
Master of Pediatric Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Scencie, Nursing and Midvifry Faculty, Hezarjreeb street
City
Isfahan
Postal code
Phone
+98 31 1792 2895
Fax
Email
msf222mmh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of medical scencie, Nursing and Midvifry Faculty
Full name of responsible person
Maryam Marofi
Position
Master of Pediatric Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Scencie, Nursing and Midvifry Faculty, Hezarjreeb street
City
Isfahan
Postal code
Phone
+98 31 1792 2906
Fax
Email
marofi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical scencie, nursing and midvifry faculty
Full name of responsible person
Motahareh Sirousfard
Position
Master of Pediatric Nursing
Other areas of specialty/work
Street address
Isfahan University of medical scencie, Nursing and Midvifry Faculty, Hezarjreeb street
City
Isfahan
Postal code
Phone
+98 31 1792 2895
Fax
Email
msf222mmh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)