Protocol summary

Study aim
Determination of the effectiveness of choice theory on marital intimacy and sexual satisfaction of newly married women
Design
The present study is a randomized controlled clinical trial.
Settings and conduct
In order to carry out the present research, the researcher selected 5 out of 14 health centers of Ardabil City in a randomized way. After obtaining the necessary permissions and determining the target community and preparing the required research questionnaires and taking into account ethical considerations, these centers will be identified. Then, marital Intimacy Inventory and sexual satisfaction questionnaires will be provided to women who come to these centers, A total of 70 women who have scored lower grades (less than 67 for sexual satisfaction and less than 60 for marital intimacy) in these two questionnaires will be included. The subjects are randomly assigned to two groups of 35 individuals (intervention and control groups). After planning and familiarizing the intervention group with the present plan, the group's real-life therapy sessions will be conducted in 8 sessions. One week and, then, one month after the completion of the sessions, sexual satisfaction and marital intimacy questionnaires will be completed by the participants.
Participants/Inclusion and exclusion criteria
In Married women who have been living with thier spouse in between 6 months to 5 years. Women aged between 18 to 35. Women who have no children. Women with scores below 17 in (sammit) quistionaire;women with scires below 50 in (jensi) quistionaire Women without any physical or psychological disorder Women who can write and read in persian
Intervention groups
New married women
Main outcome variables
Reality thrapy on marital intimacy and sexual satisfaction of newly married women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190622043969N1
Registration date: 2019-10-25, 1398/08/03
Registration timing: retrospective

Last update: 2019-10-25, 1398/08/03
Update count: 0
Registration date
2019-10-25, 1398/08/03
Registrant information
Name
Afsoun Farhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 2570
Email address
afsounfarhady@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of reality therapy with choice theory approach on marital intimacy and sexual satisfaction of young married women
Public title
Effectiveness of reality therapy on marital intimacy and sexual satisfaction of women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who have been living with thier spouse in between 6 months to 5 years. Women aged between 18 to 35. Women who have no children. Women with scores below 17 in (sammit) quistionaire;women with scires below 50 in (jensi) quistionaire Women without any physical or psychological disorder Women who can write and read in perisan
Exclusion criteria:
Women who are pregnant during the research Absence more than twice Women who have no desire to participate
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Once participants in research are determined،they are randomly assigned into intervention and control group using quartile blockes
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
Shahroud Medical scince university
Street address
Hafte tir squar،Shahroud Medical scince university
City
Shahroud
Province
Semnan
Postal code
5615786346
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.SHMU.REC.1398.028

Health conditions studied

1

Description of health condition studied
marital intimacy and sexual satisfaction of women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Marital intimacy
Timepoint
pre-intervention, one weak after intervention, one month after intervention
Method of measurement
Marital Intimacy Scale

2

Description
Sexual Satisfaction
Timepoint
pre-intervention, one weak after intervention, one month after intervention
Method of measurement
Sexual Satisfaction Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training program for the intervention group will be presented in 8 sessions for 90 minutes. The intervention principle in the intervention group is on the basis of the effectiveness of the reality therapy with the theory of choice technique intervention. During the training sessions, combination methods such as face-to-face teaching, group discussion, and distribution of pamphlet are used. The training of newly married women will be done according to the protocol presented in a group of 35 participants.Another considerable issue in this area is training group members to discuss their needs. They are trained to cooperate with each other in a way which leads to both parties satisfaction. In order for couples to assess their own needs and that of their spouse, they are trained to be aware of the qualitative world of themselves and their spouse. Some of the questions used to explore the qualitative world of the person are: If you could choose a place to be there, where would you choose? What would you like to do if you secretly heard someone telling good thing about you, what would you like to hear from him? Evaluating the content of previous sessions and post-test performance. While reviewing the main points of the previous session and answering the questions and issues facing the members in the previous session, evaluating the members in terms of understanding concepts such as behavior selection, internal and external control, qualitative world, basic needs, behavior evaluation, seven behaviors and seven destructive behaviors are dealt with.Researchers believe that if couples do not meet and understand each other’s needs and fail to find a positive solution to achieve these needs, this will lead to stress, frustration, anger and ultimately marital distress ( Atari, Hosseinpour & Rahnavard, 2009). In other words, the existence of serious and pervasive problems of couples in maintaining and developing a close relationship and meeting each other’s expectations and needs can lead to dissatisfaction between the couple and family disruption. Due to detrimental effects of this issue on couples and other family members, it is urgent to address and solve this problem (Taqavi, Taiarpour, and Hashemizadeh, 1977). Thus, regarding the importance satisfying sexual needs of the couples within the context of marital relationship and the role these needs play in developing a healthy relationship between couples ( Crawford & Anger, 2004), it seems quite essential to provide counseling and psychotherapy training and intervention to enrich couple’s relationship and prevent marriage instability. Theory based reality therapy is one of those approaches which emphasizes the importance of responsibly satisfying needs and their role in the personal and interpersonal life of an individual. Despite extensive research background in effectiveness of reality therapy on different aspects of marital life and newly-married couples, there is not enough studies or research about the efficiency of this approach in Iran. Since the field of counseling in midwifery is new in Iran, there is no study or research to investigate the effectiveness of reality therapy based on the ‘theory of choice’ among newly-married couples. Conducting research on this topic seems essential in midwifery counseling.The difference between our study and the previous ones is in different research variables. The effectiveness of choice-based reality theory on the sexual satisfaction of newly-married women has not been established in Iran. And since our aim is not to develop a new protocol; therefore, the choice-based reality therapy protocol will be used for selected couples. The details are as follows:Session 1: introduction and stating the general principles of the sessionSession 2: conceptualizing marital issues using the principle of controllingSession3: conceptualizing marital issues using the essential needs principleSession 4: conceptualizing marital issues using the qualitative world principleSession 5: introduction to behavioral systemSession 6: evaluating current behaviorSession 7: marriage problem solving circleSession 8: evaluating the educational content of previous sessions and post test
Category
N/A

2

Description
A 3-session training course will be provided according to the researcher's commitment and to observe the research ethics in order to thank the control group attendance
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers Ardabil City
Full name of responsible person
Dr.Omran Khosravi
Street address
Abuzar Street
City
Ardabil City
Province
Ardabil
Postal code
5615813165
Phone
+98 45 3277 1070
Email
Farhadi.a@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohamad Hasan Emamin
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5014
Email
emamian@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
Afsoun farhadi
Position
MS Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3932 5018
Email
afsounfarhady@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahrbano Salehin
Position
Phd of Reprodactive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3932 1850
Email
drbsalehin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Afsoun Farhadi
Position
MS Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
5615786346
Phone
+98 23 3239 1805
Email
Farhadi.a@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
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
All potential data shall be shared once the individuals' identification is eliminated
When the data will become available and for how long
Data is accessible 9 months after publication
To whom data/document is available
Data will be only available for researchers in institutes and universities
Under which criteria data/document could be used
individual who have already obtained permissions can ask unidentifiable data from researchers
From where data/document is obtainable
Afsoun Farhadi, Shahroud University of Medical Sciences
What processes are involved for a request to access data/document
9 months after publication
Comments
N/A
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