Abstract: The goal of this study is determining of the effect of aromatherapy with orange perfume on pain, anxiety and vital signs of patients with limbs fracture hospitalized in emergency ward.
Inclusion Criteria: Age above 18; Intact visual and smell senses.
Exclusion Criteria: No tendency for continuing the study; Transfer to other wards. 100 patients with limbs fractures selected conveniently. Then based on blocking randomized method, allocated into two intervention and control groups. This study will be accomplished during a shift (morning or evening). In intervention group besides doctor’s order, 4 drops of orange perfume is poured on a pad and then it connected to the patient’s collar with a distance of 20 centimeter. Every 1 hour the old pad replaced by new one. Then every 1 hour (up to 6 h.) the patient’s pain level and vital signs will be measured. The patient’s anxiety level will be measured only before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607124519N6
Registration date:2016-07-30, 1395/05/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Davood Hekmatpou
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3645
Email address
dr_hekmat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-10-11, 1395/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aromatherapy with orange perfume on pain, anxiety and vital signs of patients with limbs fracture
Public title
The effect of aromatherapy with orange perfume on pain, anxiety and vital signs of patients with limbs fracture hospitalized in Emergency Ward
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Age above 18; Intact visual and smell senses.
Exclusion Criteria: No tendency for continuing the study; Transfer to other wards.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Arak University of Medical Sciences
Street address
Payambare Azam Complex, Sardasht
City
Arak
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.ARAKMU.REC.1395.111
Health conditions studied
1
Description of health condition studied
Limb Fracture
ICD-10 code
T02.6
ICD-10 code description
Fractures involving multiple regions of upper limb(s) with lower limb(s)
Primary outcomes
1
Description
Pain
Timepoint
Every 1 hour
Method of measurement
Visual Analogue Scale
2
Description
Vital Signs
Timepoint
Every 1 hour
Method of measurement
Blood pressure apparatous
Secondary outcomes
1
Description
Anxiety
Timepoint
Before and After intervention
Method of measurement
Speilberger State Anxiety Inventory
Intervention groups
1
Description
Intervention Group:
In intervention group besides doctor’s order, 4 drops of orange perfume is poured on a pad and then it connected to the patient’s collar with a distance of 20 centimeter. Every 1 hour the old pad replaced by new one. Then every 1 hour (up to 6 h.) the patient’s pain level and vital signs will be measured. The patient’s anxiety level will be measured only before and after intervention.
Category
Other
2
Description
Control Group:
Control group: Only doctor’s orders for relieving the patient's pain and anxiety level will be accomplished. Then every 1 hour (up to 6 h.) the patient’s pain level and vital signs will be measured. The patient’s anxiety level will be measured only before and after intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie Asr Hospital
Full name of responsible person
Dr. Hekmatpou
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor Of Research, Arak University of Medical Sciences
Full name of responsible person
Dr. Rafiei
Street address
Payambare Azam Complex, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor Of Research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Hekmatpou
Position
Faculty Member
Other areas of specialty/work
Street address
Payambare Azam Complex, Sardasht
City
Arak
Postal code
Phone
+98 86 3414 3505
Fax
Email
hekmatpou@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hekmatpou
Position
Ph.D
Other areas of specialty/work
Street address
Payambare Azam Complex, Sardasht
City
Arak
Postal code
Phone
+98 86 3414 3505
Fax
Email
hekmatpou@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hekmatpou
Position
Faculty Member
Other areas of specialty/work
Street address
Sardasht Sq.
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)