The purpose of this study is to determine the effect of EMLA cream on pain of intrauterine device insertion. It is a randomized clinical trial study. Candidate women for intrauterine device insertion (n=100), who had eligible criteria(Including: age between 20 to 35 years without contraindication IUD insertion, to between 2 and 5 days of menstruation), were recruited in this study and randomized into two groups: (1) EMLA cream (n=50), (2) placebo group (n=50).In both groups, 5 g cream be used after insertion of a speculum on the cervix area. Data were collected by demographic questionnaire and pain visual analogue scale.Pain in the fifth round after speculum insertion, after applying Tenaculum، removal Hysterometer and after IUD inserion and extubation insertion tube was measured. Average pain induced by IUD insertion was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209015698N4
Registration date:2012-10-05, 1391/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-05, 1391/07/14
Registrant information
Name
Mahbobeh Ahmadi
Name of organization / entity
Shahid Beheshti University of Medical & Health Service
Country
Iran (Islamic Republic of)
Phone
+98 21 7747 5651
Email address
mah.ahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of EMLA cream and placebo on pain during IUD insertion in women referred to health centers of Imam Hussein.
Public title
Effect of EMLA cream on pain during insertion of IUD
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Women aged 35-20 year؛ Visit during menstruation (days 5-1 cycles)؛ Do not use pain medication (acetaminophen, ibuprofen, mefenamic acid) 6 hours before visiting؛ No contraindication for IUD insertion
exclusion criteria: Sensitivity EMLA cream (Genesis symptoms of itching, burning, swelling in the area of the cervix)؛ uterine size less than 6 cm and 9 cm؛ Cervical stenosis
Age
From 20 years old to 35 years old
Gender
Female
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)
Triple 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
next to Ayatollah Taleghani Hospital, Evin, Shahid Chamran Highway,Tehran.
City
Tehran
Postal code
Approval date
2012-07-08, 1391/04/18
Ethics committee reference number
400/3383
Health conditions studied
1
Description of health condition studied
Pain of iud insertion
ICD-10 code
Z30.1
ICD-10 code description
Presence of (intrauterine) contraceptive device
Primary outcomes
1
Description
pain IUD insertion
Timepoint
after application of Speculum, tenaculum, hysterometer, insertion IUD and instrument removal
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, seven minutes before insertion of the IUD, 5 g EMLA cream placed on the cervix area with swab cotten.
Category
Treatment - Drugs
2
Description
In the second group, seven minutes before insertion of the IUD 5 g placebo cream placed on the cervix area with swab cotten.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Medical Center
Full name of responsible person
Ms. Biglari
Street address
Imam Hussein Medical Center, Khezr, Hamedan.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Masoume Simbar
Street address
School of Nursing and Midwifery, Niayesh blvd Valiasr st cross, Tehran.
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
Fatemiye Hospital.
Full name of responsible person
Samira Tavakolian
Position
Midwifery Graduate Student
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Shahidi Zamani blvd, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1827 3862
Fax
Email
samira.tavakolian@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
Mahboubeh Ahmadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh blvd Valiasr st cross, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemiyeh Hospital
Full name of responsible person
Samira Tavakolian
Position
Midwifery Graduate Student
Other areas of specialty/work
Street address
Fatemiyeh Hospital, Shahid Zamani blvd, Hamedan
City
Hamedan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)