Protocol summary

Study aim
Determining the effect of problem-solving skills training on women IUI candidates
Design
49 women with iui candidate and admission criteria were assigned to two groups of intervention and control by simple random method. subsequently, the intervention group was trained in problem- solving skills and the control group did not receive any training.
Settings and conduct
An experimental study was a pre-test and post-test type and conducted in Moheb Yas Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Women candidates for IUI; minimum reading and writhing education; no history of any psychological counseling; no history of antidepressant and anti-anxiety medication; no drug addiction; failure to receive other assisted reproductive techniques.
Intervention groups
Problem-solving skills training
Main outcome variables
anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171216037912N1
Registration date: 2018-02-11, 1396/11/22
Registration timing: retrospective

Last update: 2018-02-11, 1396/11/22
Update count: 0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Fateme Zarekia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0310
Email address
f.zarekya@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-08-22, 1394/05/31
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
2015-08-22, 1394/05/31
Actual recruitment end date
2015-12-16, 1394/09/25
Trial completion date
empty
Scientific title
Problem Solving Skills Training Effect on Women's Anxiety of Intra Uterine Insemination Candidates
Public title
Problem Solving Skills Effect on Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for IUI Minimum reading and writhing education No history of any psychological counseling No history of antidepressant and anti-anxiety medication No drug addiction Failure to receive other assisted reproductive techniques
Exclusion criteria:
Gain score less than 8 from the Beck Anxiety Inventory Failure of the treatment process due to oocyte growth
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Actual sample size reached: 49
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 49 female candidates of iui were matched in different levels of anxiety and were randomly assigned to two groups of intervention and control. Randomization was done as a draw. In this way, candidates in each of the three levels of anxiety, were randomly assigned to each other through a lottery in each intervention and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Golestan University of Medical Science
Street address
Sixty Kola
City
Gorgan
Province
Golestan
Postal code
49165-567
Approval date
2015-08-20, 1394/05/29
Ethics committee reference number
IR.GOUMS.REC.1394.72

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Those who received Beck Anxiety Inventory (8 and above) were included in the study. The subjects were ranked according to the levels of anxiety and were randomly assigned to intervention (25 subjects) and control (n = 24).
Timepoint
From the beginning of the sampling and teaching the problem-solving skills to the intervention group, by the end of the training and the Beck anxiety inventory questionnaire were completed by all intervention and control group participants, 15 weeks were spent.
Method of measurement
Beck anxiety inventory (BAI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Moheb Yas Hospital
Full name of responsible person
Fatemeh Zarekia
Street address
North Villa Rd
City
Tehran
Province
Tehran
Postal code
3361696586
Phone
+98 21 4216 0000
Email
f.zarekya@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gorgan University of Medical Sciences
Street address
Shast Kolla
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
rhrc@goums.ac.ir
Grant name
36470000
Grant code / Reference number
92158105
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Zarekia
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan University of Medical Sciences, Shast Kola
City
Gorgan
Province
Golestan
Postal code
3361696586
Phone
+98 26 4422 9469
Email
f.zarekya@goum.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Zarekia
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan University of Medical Sciences, Shast Kola
City
Gorgan
Province
Golestan
Postal code
567-49165
Phone
+98 26 4422 9469
Email
f.zarekia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Zarekia
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gorgan University of Medical Sciences, Shast Kola
City
Gorgan
Province
Golestan
Postal code
۳۳۶۱۶۹۶۵۸۶
Phone
+98 26 4422 9469
Email
f.zarekia@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Some sample sized are not satisfied.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...