The aim of this randomized controlled trial is to compare three different approaches for increasing clients’ understanding of contraceptive effectiveness. We will recruit 630 reproductive age married women with at least 6 years education at selected public health centers/posts in Tabriz, Iran. After getting written informed consent, participants will complete a self-administered questionnaire about demographic and reproductive characteristics and three questions regarding effectiveness of various contraceptive methods. Then, we will randomize them to one of three charts presenting pregnancy risk. For group assignment, we will use permuted block randomization with block sizes of 6 and 9 concealed in sequentially numbered, sealed, opaque envelops. Participants will complete a second set of the effectiveness questions while looking at their assigned chart. Finally, after one month, an interviewer, who is blind to the random allocation, will ask the same three questions from the subjects through phone contact.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903093706N2
Registration date:2011-05-05, 1390/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-05, 1390/02/15
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Tabriz University of Medical Sciences
Expected recruitment start date
2011-01-22, 1389/11/02
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial of communicating contraceptive effectiveness
Public title
Comparison of three different approaches for communicating contraceptive effectiveness
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Female clients of the selected health centers and health posts who are married, aged 15-49, have at least 6 years education, are residents of Tabriz city and have telephone line.
Exclusion criteria:
use permanent contraceptive methods
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
630
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy of Tabriz university of medical sciences
Street address
Tabriz -Golgasht street
City
Tabriz
Postal code
51665118
Approval date
2010-10-22, 1389/07/30
Ethics committee reference number
6729
Health conditions studied
1
Description of health condition studied
Womenُs understanding about contraceptive effectiveness
ICD-10 code
Z30.0
ICD-10 code description
General counselling and advice on contraception
Primary outcomes
1
Description
Knowledge of the women
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Self-administered questionaire in pre-intervention and immediately after intervention and by telephone interview one month after intervention
Secondary outcomes
empty
Intervention groups
1
Description
Group A: asking the participants to look at chart 1 presenting contraceptive effectiveness information (Categorizing the methods into four groups 'least effective', 'effective', 'very effective' and 'most effective' and presenting typical percentage of preganacy in the first year use for each method)
Category
Other
2
Description
Group B: asking the participants to look at chart 2 presenting contraceptive effectiveness information (Categories)
Category
Other
3
Description
Group C: asking the participants to look at chart 3 presenting contraceptive effectiveness information (Continuum presenting 'less effective' on the bottom and 'more effective' on the top)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Molla-Rasuli
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Shamse Tabrizi street
City
Tabriz
2
Recruitment center
Name of recruitment center
Golpark
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Valyasr-tavanyr Street
City
Tabriz
3
Recruitment center
Name of recruitment center
Bareng
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Bareng
City
Tabriz
4
Recruitment center
Name of recruitment center
Zaafaraniye
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Zaafaraniye
City
Tabriz
5
Recruitment center
Name of recruitment center
Shahid Sadeghi neghad
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Hojjati Street
City
Tabriz
6
Recruitment center
Name of recruitment center
Shahid Babaii
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Shahrak Parvaz square
City
Tabriz
7
Recruitment center
Name of recruitment center
Manzariyyeh
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Aboureyhan crossroad
City
Tabriz
8
Recruitment center
Name of recruitment center
Shahid Taymouri
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Laleh crossroads
City
Tabriz
9
Recruitment center
Name of recruitment center
Shanbe Ghazan
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Santo road
City
Tabriz
10
Recruitment center
Name of recruitment center
Molla Hasan
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
End off Street Saghatoleslam
City
Tabriz
11
Recruitment center
Name of recruitment center
Shahid Chamran
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Shahid Chamran town
City
Tabriz
12
Recruitment center
Name of recruitment center
Gharamolk
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Gharamolk street
City
Tabriz
13
Recruitment center
Name of recruitment center
Gomtape
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Yeka dokan
City
Tabriz
14
Recruitment center
Name of recruitment center
Khatib
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Khatib street
City
Tabriz
15
Recruitment center
Name of recruitment center
Hokm Abad(1)
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Bahar street
City
Tabriz
16
Recruitment center
Name of recruitment center
Ghods
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Ghods street
City
Tabriz
17
Recruitment center
Name of recruitment center
Roshdiyeh
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Roshdiyeh town
City
Roshdiyeh
18
Recruitment center
Name of recruitment center
Shahiidan ebrahimi
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Allay University street
City
Tabriz
19
Recruitment center
Name of recruitment center
Bani shafie
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Akhoni street
City
Tabriz
20
Recruitment center
Name of recruitment center
Sherkate nafte 1 golestan
Full name of responsible person
Jahanbakhsh-R ogayyeh
Street address
Between khatib and rahahan crossroads
City
Tabriz
21
Recruitment center
Name of recruitment center
Pastore no
Full name of responsible person
Jahanbakhsh-R ogayyeh
Street address
Monajjem street
City
Tabriz
22
Recruitment center
Name of recruitment center
Mohajerin
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Santo road
City
Tabriz
23
Recruitment center
Name of recruitment center
Traktor sazi
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Dizel abad
City
Tabriz
24
Recruitment center
Name of recruitment center
Farhangiyan
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Hefdahe shahrivar street
City
Tabriz
25
Recruitment center
Name of recruitment center
Payegahe havaei
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Azarbayjan square
City
Tabriz
26
Recruitment center
Name of recruitment center
Bime tamine ejtemaei
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Melale mottahed street
City
Tabriz
27
Recruitment center
Name of recruitment center
Seyyed hamze
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
The front of maghbaratolshoara
City
Tabriz
28
Recruitment center
Name of recruitment center
Hokm abad 2
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Hokm abad 20 metry street
City
Tabriz
29
Recruitment center
Name of recruitment center
Sadi
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Sadi street
City
Tabriz
30
Recruitment center
Name of recruitment center
Markaze amozeshi darmani alzahra
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Arteshe jonobi street
City
Tabriz
31
Recruitment center
Name of recruitment center
Mojahedin
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Mofatteh street
City
Tabriz
32
Recruitment center
Name of recruitment center
Enghelab
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Pasdaran street
City
Tabriz
33
Recruitment center
Name of recruitment center
Golkar
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Golkar
City
Tabriz
34
Recruitment center
Name of recruitment center
Razi shahrak
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Razi town
City
Tabriz
35
Recruitment center
Name of recruitment center
Sina
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Azadi street
City
Tabriz
36
Recruitment center
Name of recruitment center
Bagmishe Shahrak
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Bagmishe town
City
Tabriz
37
Recruitment center
Name of recruitment center
Valiasre jonobi
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Shahid mahalati street
City
Tabriz
38
Recruitment center
Name of recruitment center
Silab
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Abbasi street
City
Tabriz
39
Recruitment center
Name of recruitment center
Dadgostari kooy
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Sahand town
City
Tabriz
40
Recruitment center
Name of recruitment center
Mashin sazi
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
santo road
City
Tabriz
41
Recruitment center
Name of recruitment center
Baghiyatollah
Full name of responsible person
Jahanbakhsh-Rogayyeh
Street address
Bahar
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chencellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research deputy, Tabriz university of medical sciences, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chencellor for Research, Tabriz 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
Tabriz Univercity of Medical Sciences-Faculty of Nursing and Midwifery Tabriz
Full name of responsible person
Rogayyeh Jahanbakhsh
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South shariati
City
Tabriz
Postal code
Phone
+98 41 1555 8876
Fax
Email
jrogayye156@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Tabriz university of Medical sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-charandabi
Position
Assistant Professor/Phd in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
alizades@tbzmed.ac.ir; smoalch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz university of medical sciences
Full name of responsible person
Rogayyeh Jahanbakhsh
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
jrogayye156@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)