Protocol summary

Study aim
Determine and compare the effectiveness of group and paired-group counseling based on cognitive-behavioral approach on stress in infertile women
Design
Three groups of clinical trials with control group, the total number of participants were 78 infertile women in three groups with 26 individuals in each group, with parallel, double blind, randomized groups
Settings and conduct
The statistical population is referring to infertility centers of Sari city, which are diagnosed by their infertility gynecologist and are under medical treatment. After three groups of group counseling, group counseling and control group were randomly selected, counseling was conducted for two intervention groups. Questionnaires are filled up for each of the three groups before and after the intervention. Then the results are compared and compared.
Participants/Inclusion and exclusion criteria
Entry requirements: Primary infertility, the age range of 20-35 year olds, the length of infertility between 1 and 7 years, the residence in the city of Sari, as well as the possibility of continuous participation in group or paired counseling sessions, having a minimum stress score of 46 Newton's questionnaire, lack of previous pregnancy history, lack of history of admission due to mental disorders, lack of presence in support groups, lack of attendance counseling sessions and paired treatment outside the study, lack of attendance in classes of relaxation, unnecessary surgical procedures to resolve Infertility in men and women
Intervention groups
The intervention group is a group where group counseling sessions are held to improve their stress and the control group is also selected to compare with them.
Main outcome variables
The rate of change in stress score in the intervention group and its comparison with the control group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180128038533N1
Registration date: 2018-05-20, 1397/02/30
Registration timing: registered_while_recruiting

Last update: 2018-05-20, 1397/02/30
Update count: 0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Hosna Meskar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 1353
Email address
meskar@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of group and couple-group cognitive-behavioral counselling on stress in infertile women
Public title
Comparison of efficacy of group and couple-group cognitive-behavioral counselling on stress in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primary infertility the age range of 20-35 year olds the length of infertility between 1-7 years The residence in the city of Sari, and the possibility of continuous participation in group or couple counseling sessions Having a minimum stress score of 46 according to the Newton questionnaire Not having previous pregnancy history Not having a history of admission due to mental disorders Not present in support groups Not attending counseling sessions and Couples Therapy Outside Research Not attending relaxation classes No need for surgical procedures for the elimination of infertility in males and females
Exclusion criteria:
History of hospitalization due to mental disorders Use of any psychiatric medication
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is used to equalize the sample size in all studied groups from blocks of 6 in a way that will be located in each block of 6 people. Random sequence generation is done by random allocation software and by someone outside the research team. Individuals will be placed in the 6-block blocks in the order of days.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, interventional and analyst, do not know which participants are in the group. Participants will organize their training sessions in different days and locations. Intervener blinding is used to assign individuals to groups from another person. We do not inform the analyst of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahrood University of Medical Sciences & Health Services. May 7th. Semnan. Shahrood city. Iran
City
Shahrood
Province
Semnan
Postal code
36147-73947
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
ir.shmu.rec.1396.142

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
The percentage of high stress participants
Timepoint
The questionnaire is filled out once before the intervention and once after the end of the eighth session and once a month after the end of the intervention.
Method of measurement
Newton fertility inventory questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The first group is consisted of infertile women who participate in two hours cognitive-behavioral group counseling for 8 sessions.
Category
Behavior

2

Description
Intervention group:The second group is consisted of infertile women who participate in two hours cognitive-behavioral couple-group counseling for 8 sessions.
Category
Behavior

3

Description
Control group:A group with no educational intervention is selected and compared to the intervention group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Maryam
Full name of responsible person
Sepide Peyvandi
Street address
Next to the Half Sha'ban Hospital. Pasdaran Blvd. Imam square. Sari city. Mazandaran province. Iran
City
Sari
Province
Mazandaran
Postal code
4818814635
Phone
+98 11 3334 3333
Email
info@ivfsari.com

2

Recruitment center
Name of recruitment center
Imam Khomeini Center
Full name of responsible person
Dr.Zamanian
Street address
Imam Khomeini Hospital. Razi street. Sari city. Mazandaran province. Iran
City
Sari
Province
Mazandaran
Postal code
4818814635
Phone
+98 11 3336 1700
Email
meskar@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahrood University of Medical Sciences & Health Services. May 7th. Semnan. Shahrood city. Iran
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Hosna Meskar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences & Health Services. May 7th. Semnan. Shahrood city. Iran
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
meskar@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nahid Bolbol Haghighi
Position
professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences & Health Services. May 7th. Semnan. Shahrood city. Iran
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
nbhaghighi349@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hosna Meskar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences & Health Services. May 7th. Semnan. Shahrood city. Iran
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
meskar@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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