Background: The aim of this study was to evaluate the effects of lavender essential oil on anxiety and pain of intrauterine insertion.
Method: This is a randomized single blind clinical trial. A sample of women attending a family planning center in Tehran, Iran are entered into the study. They will be randomly assigned into three equal groups, one for lavender essential oil (n=45) and two for placebo (n-=45) and other for control group (n-=45). In all 135 are participated in this study. Data are collected by demographic questionnaire and speilberger questionnair and visual analog scale of Jhonson. The SPSS version 16.0 is use to analyze the data. Descriptive analyses is carry out to explore the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209266206N4
Registration date:2012-11-04, 1391/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-04, 1391/08/14
Registrant information
Name
Parvin Rahnama
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8587
Email address
prahnama@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2008-10-25, 1387/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lavender essential oil on anxiety and pain during insertion of intrauterine device
Public title
Effect of smelling of lavender essential oil on anxiety and pain during insertion of intrauterine device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: there is no psychology disease; anxiety; influanza and no smoking.
Exclusion criteria: sensitivity or allergy to perfume and essential oil.
Age
From 17 years old to 47 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences.
Street address
Ghods St, Keshavarz Blv, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2008-05-12, 1387/02/23
Ethics committee reference number
6624/ص
Health conditions studied
1
Description of health condition studied
IUD insertion
ICD-10 code
Z30.1
ICD-10 code description
Insertion of (intrauterine) contraceptive device
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger questionnaire
2
Description
Pain
Timepoint
After intervention and after IUD insertion
Method of measurement
Visual analoug scale of jhonson
Secondary outcomes
empty
Intervention groups
1
Description
The women's will give a box containing a cotton ball soak with three drops of sesame oil. The womens will aske to inhale the box from 7 to 10 centimeter from nose.The apparent and acute anxiety determine in all before and after aromatherapy just before intra uterine device insertion
Category
Placebo
2
Description
control groups will receive routine care.
Category
Other
3
Description
The women's give a box containing a cotton ball soak with three drops of lavender essential oil . The women ask to inhale the box from 7 to 10 centimeter from nose.
The apparent and acute anxiety will determine in group before and after aromatherapy just before intra uterine device insertion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
family planning center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
Ghods St, Keshavarz Blv,
City
Teharn
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 of Tehran 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
Shahed University
Full name of responsible person
Parvin Rahnama
Position
Assistant professor
Other areas of specialty/work
Street address
Enghelab Sq, Kargar St, Shahed
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
prahnama@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of nursing and midwifery,Tehran University of Medical Sciences
Full name of responsible person
Mandana Mirmohammadali e
Position
Instructor,MSc
Other areas of specialty/work
Street address
Tohid Sq, Nosrat St., Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran University of Medical
City
Tehran
Postal code
Phone
+98 66927171
Fax
Email
mirmohamad1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
parvin rahnama
Position
Assisstant Professor
Other areas of specialty/work
Street address
Valie asr
City
Tehran
Postal code
Phone
+98 48 22258
Fax
Email
p_rahnama1381@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)