Background and aim: Intrauterine device (IUD) is a safe, effective and reversible method; however IUD insertion is associated with pain. The purpose of this study was to determine the effect of chammomile essential oil on pain of intrauterine device insertion. Materials and Methods: It was a randomized clinical trial study. Candidate women for intrauterine device insertion (n=150), who had eligible criteria, were recruited in this study and randomized into three groups: (1) chammomile group (n=50), (2) placebo group (n=50) and (3) control group (n=50). Data were collected by demographic questionnaire and pain visual analogue scale. Average pain induced by IUD insertion was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202078950N1
Registration date:2012-03-01, 1390/12/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Mina Kashiha
Name of organization / entity
Nursing and Midwifery school, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 483 0396
Email address
pr_shohada@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-03-03, 1389/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chammomile essential oil on pain intensity of IUD insertion
Public title
The effect of chammomile essential oil on pain of IUD insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages between 18-48 years; Iranian race; speaking in Farsi; can read & write; no cold or smelling disorder; no usage of alleviating during last 24 hours; no smoking or opiate; no asthma. Exclusion criteria: allergy to chammomil; misusages of chammomil.
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Shahid Beheshti University of Medical Sciences
Street address
Niayesh blvd., Valiasr st. cross
City
Tehran
Postal code
Approval date
2011-01-09, 1389/10/19
Ethics committee reference number
1-7282-86-01-89
Health conditions studied
1
Description of health condition studied
pain in IUD insertion
ICD-10 code
Z97.5
ICD-10 code description
Presence of (intrauterine) contraceptive device
Primary outcomes
1
Description
pain
Timepoint
immediately after IUD insertion
Method of measurement
pain ruler
Secondary outcomes
empty
Intervention groups
1
Description
Second group: placebo (propylene glycol) usage in the same manner as first group.
Category
Placebo
2
Description
Third group use nothing.
Category
N/A
3
Description
First group: aromatherapy with chammomil essensial oil. We use 3 drops of chammomil essensial oil on a cotton and put it in the caped dark glass. Before IUD insertion they should inhale it for 5 minutes from a distance of 7-10 cm from their nose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Fardis health services
Full name of responsible person
Mrs Sadidy
Street address
Kanale-ab avenue
City
Karaj
2
Recruitment center
Name of recruitment center
Shohadaye Aghtape health services
Full name of responsible person
Mrs Pakdaman
Street address
west street, Valiasr blvd, Aghtape
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Khodakarami
Street address
Taleghani hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Kashiha
Position
master of science
Other areas of specialty/work
Street address
Shohada hospital
City
Tehran
Postal code
Phone
+98 26 1352 3388
Fax
+98 21 2271 9014
Email
kashiha87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Khodakarami
Position
master of science
Other areas of specialty/work
Street address
Taleghani hospital (infertility research center)
City
Tehran
Postal code
Phone
+98 912 186 0310
Fax
+98 21 2271 9014
Email
khodakarami@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Kashiha
Position
master of midwifery
Other areas of specialty/work
Street address
Ghods sq., Tajrish
City
Tehran
Postal code
Phone
+98 26 1352 3388
Fax
Email
kashiha87@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)