Determining the effect of group counseling based on life skills on sexual intimacy of reproductive age women
Design
A randomized clinical trial with control and intervention groups, with a sample size of 118 people
Settings and conduct
This study will be conducted as a randomized controlled trial on all married women referring to Khalkhal health centers who are willing to participate in the study.
At first, the eligible samples were entered into the study with the easy sampling method, and the block method (blocks of four) will be used to randomly assign the samples to two intervention and control groups. Thus, in blocks of 4, two allocations to the intervention group and two allocations to the control group were considered, and there were a total of 6 cases. The blocks of four created will be selected in such a way that the sample size is 118 people.
Participants/Inclusion and exclusion criteria
Entry criteria: age between 18 to 40 years old; getting a score of 60 and below from the sexual intimacy questionnaire (low sexual intimacy).
Non-entry criteria: mentioning sexual abuse or harassment before marriage; absence of physical and mental illness
the presence of special conditions that prevent normal sexual relations with the spouse; taking neuropsychiatric drugs
infertility for any reason; medical prohibition for having children; menopause; previous attendance at sex education classes
smoking, tobacco and drugs.
Intervention groups
In the intervention group, counseling will be provided to the test group in the form of 5 groups of 10 people and one group of 9 people. The intervention will be implemented for 8 sessions (two sessions per week) for the test group. There will be no intervention in the control group.
Main outcome variables
Sexual intimacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201113049377N3
Registration date:2023-05-16, 1402/02/26
Registration timing:prospective
Last update:2023-05-16, 1402/02/26
Update count:0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
Parvin Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 6258
Email address
p.mohebbi11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on life skills on sexual intimacy in women of reproductive age
Public title
The effect of counseling on sexual intimacy of reproductive age women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years old
Getting a score of 60 and below from the sexual intimacy questionnaire (low sexual intimacy)
Exclusion criteria:
Mentioning sexual abuse or harassment before marriage
Absence of physical and mental illness
The presence of special conditions that prevent normal sexual relations with the spouse
Taking neuropsychiatric drugs
Infertility for any reason
Medical prohibition for having children
Menopause
Previous attendance at sex education classes
Smoking, tobacco and drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the eligible samples were entered into the study with the easy sampling method, and the block method (blocks of four) will be used to randomly assign the samples to two intervention and control groups. Thus, in blocks of 4, two allocations to the intervention group and two allocations to the control group were considered, and there were a total of 6 cases. Blocks of four created will be selected in such a way that the sample size reaches 118 people. In order to hide the random allocation, the method of sealed opaque envelopes with a random sequence will be used. The tool for generating the sequence will be the table of random numbers.
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 of Zanjan University of Medical Sciences
Street address
Ostad Sobooti Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-04-25, 1402/02/05
Ethics committee reference number
IR.ZUMS.REC.1402.035
Health conditions studied
1
Description of health condition studied
Women of reproductive age
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual intimacy
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Bagarozzi Sexual Intimacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, counseling will be provided to the test group in the form of 5 groups of 10 people and one group of 9 people. The intervention will be implemented for 8 sessions (two sessions per week) for the test group.
Category
Lifestyle
2
Description
Control group: There will be no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Khalkhal city
Full name of responsible person
Iraj Etebar
Street address
Mozaffar St
City
Ardabil
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 2187
Email
m.beh@khalums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hossein Mostafavi
Street address
Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6142
Email
mostafavih@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, School of Nursing and Midwifery, Haj Ahmed Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
p.mohebbi11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, School of Nursing and Midwifery, Haj Ahmed Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
p.mohebbi11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Roya Salmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, School of Nursing and Midwifery, Haj Ahmed Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
roya.salmani72@yahoo.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