Comparison the effect of aromatherapy by essential oils of lavender and peppermint on the levels of pain and anxiety caused by the insertion of intravenous catheter
Objective: To compare the effect of aromatherapy with essential oils of lavender and peppermint on the levels of pain and anxiety caused by the insertion of intravenous catheter.
Design: randomized controlled clinical trial
Setting and conduct: sample size is 120 patients. Eligible patients will be selected by convenience sampling and will be randomly allocated to two interventions and one control groups.
Inclusion and exclusion criteria: inclusion criteria include Consent to participate in the study, positive reaction to smell, and absence of allergies and chronic respiratory diseases. Exclusion criteria include Unwillingness to continue to cooperation, and failed first attempt at vascular access. Exclusion criteria include the patient's unwillingness to continuing the cooperation and the failure of the first IV catheterizing.
Interventions: Initially the anxiety level will be measured by visual analogue scale. In groups one and two, essential oils of lavender and mint will be used respectively and in control group sterile water will be used. The essential oils will be spilled on the napkin and will be attached to the patient's clothing for 5 minutes, then intravenous catheter will be inserted. After fixing IV catheter, the levels of anxiety and pain will be measured by visual analogue scale and numerical scale respectively.
The main outcome variables: pain and anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612124736N20
Registration date:2017-02-05, 1395/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-05, 1395/11/17
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-07-20, 1396/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy by essential oils of lavender and peppermint on the levels of pain and anxiety caused by the insertion of intravenous catheter
Public title
Effect of aromatherapy on pain and anxiety caused by the insertion of IV catheter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion and exclusion criteria: inclusion criteria include Consent to participate in the study, positive reaction to smell, the absence of allergy and chronic respiratory diseases, and not using sedative and analgesic drugs from Six hours before the intervention
Exclusion criteria include the patient's unwillingness to continuing the cooperation and the failure of the first IV catheterizing.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Comitee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Street, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
KUMS.RES.1395.570
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
pain
ICD-10 code
M79.9
ICD-10 code description
Soft tissue disorder, unspecified
Primary outcomes
1
Description
Pain
Timepoint
after the IV insertion
Method of measurement
Numeric pain scale
2
Description
Anxiety
Timepoint
before and after the IV insertion
Method of measurement
Anxiety Visual Scale
Secondary outcomes
empty
Intervention groups
1
Description
In group two, the three drops of Peppermint essential oil will be used. Trade name of this essence is peppermint essential oil and its scientific name is Mentha piperita which is produced by Tehran Zardband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds are Menthol and methyl acetate. Essential oils will be dropped by the dropper on a napkin and will be connected to the patient's clothing at the chest area and will be inhaled for 5 minutes
Category
Other
2
Description
In group one, the Three drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula which is produced by Tehran Zardband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds are linalyl acetate and linalool. Essential oils will be dropped by the dropper on a napkin and will be connected to the patient's clothing at the chest area and will be inhaled for 5 minutes.
Category
Other
3
Description
In control group, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on a napkin and will be connected to the patient's clothing at the chest area and will be inhaled for 5 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Alireza Khatony
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences, Shahid Beheshty street, Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Kermanshah 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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza khatony
Position
PhD, Faculty Member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
Faculty member, PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, .Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)