Determine the effect of Communication Skills Training on Marital Satisfaction in Wives of Men are in Drugs Withdrawal Period
Design
Randomized field trial with a control group, and a sample size of 40 wives of men are in drugs withdrawal
Settings and conduct
there are 1 governmental drug addiction center with a population of about 600 people and 70 private drug addiction centers with a population of about 150 people in Gorgan. we divide the society into two governmental and private classes and consider each center as a cluster according to the geographical location of the addiction centers (north, center, south). Then, we select 10 women from government centers and 30 women from private centers in a two-stage cluster sampling and randomly based on the score of the questionnaire. they are categorized by Block random allocation method into two groups of control and intervention. The intervention group is invited to 8 communication skills training sessions, while the control group does not receive any counseling. In the case of statistical analyzer, there is blindness and they do not know about the intervention and control of the codes. Complete the demographic information form and Enrich marital satisfaction questionnaire with the supervision of a research collaborator (assessor of the questionnaire).
Participants/Inclusion and exclusion criteria
Wives of Men are in Drugs Withdrawal Period؛ Ages between 18 to 45 years old؛ At least one year of common life؛
Intervention groups
The experimental group will trained in 8 weeks group sessions on communication skills. Every session will last 90 minutes. The control group does not receive the sessions. Participants will complete an Enrich Marital Satisfaction Questionnaire before and after the end of the intervention
Main outcome variables
Marital satisfaction score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171026037015N5
Registration date:2018-09-30, 1397/07/08
Registration timing:registered_while_recruiting
Last update:2018-09-30, 1397/07/08
Update count:0
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Houri Alijani
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0360
Email address
alijani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Communication Skills Training on Marital Satisfaction in Wives of Men are in Drugs Withdrawal Period
Public title
Evaluation of Effectiveness of Communication Skills Training on Marital Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 to 45 years old
At least one year of common life
Being a single wife
The desire to participate in the study
The Enrich Score 120 and Lower
Exclusion criteria:
The presence of chronic psychological illnesses of couples (using a structured psychiatric interview)
Experience of severe stressful events during the past 6 months (a car crash or death of one of first grad relatives, Strong conflict in the family, especially divorce)
History of participation in psychotherapy classes and communication skills
Drug abuse of woman
Pregnancy
Lactation
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the fact that there are 1 state drug addiction center with a population of about 600 people and 70 private drug addiction centers with a population of 150 people in Gorgan, they first divide the society into two public and private classes and according to the geographical location Addiction treatment centers (north, center, south) consider each center as a cluster. Then, by choosing two-stage cluster sampling, 10 from the government center and 30 from private centers, we will randomly match and according to the graphic variables and type of use and duration of use and ..., and with the use of Using block random allocation method, we allocate ten selected from the state center to the letter A and five others to the letter B. Similarly, we divide 30 selected individuals from the private sector into two groups. Now, using a throwing coin of a group as an intervention group and a control group will enter the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistical analyzer and The outcome evaluator is not informed about intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Hirkan Blvd, The Shast kola Ave, Deputy of Research and Technology, Golestan University of Medical Sciences, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.GOUMS.REC.1397.068
Health conditions studied
1
Description of health condition studied
Wives of Men are in Drugs Withdrawal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Marital satisfaction score
Timepoint
Marital Satisfaction Score Measurement before the beginning of the first Communication Skills Training session and immediately and one month after the last session
Method of measurement
Enrich Marital Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive Communication Skills Training at 8 sessions of 90 minutes, which will be held in groups of 5 to 10 people. Training include active listening, empathy, respect for the other side, explicit, important relationship in marital relationship, conflict resolution patterns…
Category
Behavior
2
Description
Control group: Control group: No intervention received
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Clinics of Gorgan City
Full name of responsible person
Roghaieh Hajigholikhany
Street address
Abozar 7, Iranmehr Ave, Pegah Drug Clinic, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4918685346
Phone
+98 17 3222 2043
Email
roghaieh.gholikhany@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Shast kola Ave., Hirkan Blvd., Deputy of research and technology., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4915767446
Phone
+98 17 3245 1354
Email
roghaieh.gholikhany@yahoo.com
Web page address
Grant name
Grant code / Reference number
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
Roghaieh Hajigholikhany
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4914716179
Phone
+98 17 3443 0763
Email
roghaieh.gholikhany@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Fatemeh Seifi
Position
Professor Assistant and Faculty Member of Golestan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Shast kola Ave, Hirkan Blvd, Faculty of Nursing Midwifery, Golestan University of Medical Sciences, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
f_seifi2016@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Roghaieh Hajigholikhany
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4914716179
Phone
+98 17 3443 0763
Email
roghaieh.gholikhany@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
The data will be available for scientific research with reference to the research. In order to access the data, they can reply to the person's e-mail address.
From where data/document is obtainable
En responsible person's email address: roghaieh.gholikhany@yahoo.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.