Ayatollah Mousavi hospital will be selected as the Infertility Center of Zanjan. 517 cases from about 2,000 cases will be chosen with a systematic random method. Infertile women will be contacted for completing a questionnaires. The questionnaire will be completed with self – report method. If it is not possible to complete the questionnaire by person, trained interviewers will be completed it by phone. Among those willing to participate in counseling sessions, 50 available people will be divided to intervention (n = 25) and control (n = 25) groups using blocked randomization design. The control group will receive no counseling.The intervention group will be divided into two groups of 8 and one group of 9 participants. The intervention group will receive 9 sessions of 90-minute group counseling based on the choice theory. All sessions will be held in the Mousavi hospital preparation for childbirth classes by researcher. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counseling sessions, main points of each session will be presented. For the single blinding two months after the last session, the questionnaire will be completed in both the intervention and control groups by trained interviewers, who are unaware of the group assignment of people, .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061428352N2
Registration date:2016-09-15, 1395/06/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-15, 1395/06/25
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on choice theory on irrational parenthood cognition and marital quality in infertile women
Public title
The effect of group counseling based on choice theory on irrational parenthood cognition and marital quality in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria;
Irrational parenthood cognition and marital quality scores between 25 and 75 percent of the total score; Primary infertility type based on the history; Female or mixed infertility type based on the history; Lack of psychological problems in couple based on the history; Living in zanjan city; Not receiving medication for psychological problems in the last 6 months; Passing at least 6 months to 15 years or more after first diagnosis of infertility; Aged between 15-40 years old; No substance abuse in couples; At least secondary school education in women; Employment of husbands; Having a cell phone; Having tendency to participate regularly in counseling sessions; Lack of children from previous marriage in couple
Exclusion criteria:
Having no tendency to participate in counseling sessions and absence of two session; Not filling out 20 percent of questionnaires by participants; Diagnosing of mental disorders at any stage of the study
Age
From 15 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
study will be done in two phases; descriptive and experimental
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ethics committee of Zanjan University of Medical Sciences, First floor, North Side Azadi Boulevard, Zanjan
City
Zanjan
Postal code
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
zums.rec.1395.99
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Inability to achieve a pregnancy sterility, female NOS
Primary outcomes
1
Description
Irrational parenthood congition
Timepoint
At baseline and two month after the intervention
Method of measurement
Irrational parenthood congition scale
2
Description
Marital quality
Timepoint
At baseline and two month after the intervention
Method of measurement
Marital quality scale based on Glasser choice theory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1:
The intervention group of 25 persons will be divided into two groups of 8 and one group of 9 participants. The intervention group will receive 9 sessions of 90-minute group counseling based on the choice theory. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counseling sessions, main points of each session will be presented.
Category
Behavior
2
Description
Intervention 2:
The control group of 25 persons will receive no counseling.