This study was conducted to evaluate the effectiveness of counseling with mindfulness based cognitive therapy approach on women marital stress and their sexuality function.
Design
The study group includes women of reproductive age (aged 15-49) who are inclined to enter the study and have Inclusion criteria.This Study is a
semi-experimental research with Pretest - Post Test Design and a Control Group and with Convenience Sampling Method. Among those who were willing to participate in the study, 50 subjects with higher scores in the Marital Stress Questionnaire and lower scores the Sexual Function Questionnaire were selected. then Subject are Divided in two Groups Randomly. Including 50 subject Experimental group (25subject) and Control Group (25subject) .
Settings and conduct
After determining the intervention group with randomization, the subjects in the Diabetes Center of Yazd spent mindfulness workshop in 8 consecutive week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being willing to Participate in the Study; Marital Status; Age 15-49؛ Have at least Ability to read and write؛ without the use of psychiatric drugs; do not participate in another workshop courses Simultaneously with this Course; Being Committed to Doing Homework and to Attend Regular Meetings either in Time or in the Place of Mindfulness Workshop. Exclusion criteria: Pregnancy; Divorce; a History of Severe Mental Illness; having severe illness such as cancer
Intervention groups
the 50 samples were divided into two groups and the intervention group received 8 sessions of the Mindfulness Workshop. The control group also included 25 subject who did not attend any of the Mindfulness workshop, but the questionnaires of the project were similar to the intervention group and The same intervals are completed.
Main outcome variables
Marital stress, sexual function, Mindfulness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170326033140N2
Registration date:2018-02-12, 1396/11/23
Registration timing:retrospective
Last update:2018-02-12, 1396/11/23
Update count:0
Registration date
2018-02-12, 1396/11/23
Registrant information
Name
ferdows mohammadalian
Name of organization / entity
shahid sadoughi university of medical sciences and healthservices
Country
Iran (Islamic Republic of)
Phone
+98 35 3628 5402
Email address
f.mohammadalian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2017-12-23, 1396/10/02
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-09-16, 1396/06/25
Actual recruitment end date
2017-10-17, 1396/07/25
Trial completion date
empty
Scientific title
The Effectiveness of Group Counseling Mindfulness-Based Cognitive Therapy on Marital Stress and Sexual Function in Women of Reproductive Age
Public title
The effectivnes of Mindfulness-Based Cognitive Therapy on Marital Stress and Sexual Function in Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being willing to Participate in the Study
Marital Status
Age 15-49
Have at least Ability to read and write
not using of psychiatric drugs
Not attending in another workshop courses Simultaneously with this Course
Being Committed to Doing Homework and to Attend Regular Meetings either in Time or in the Place of Mindfulness Workshop
Exclusion criteria:
Pregnancy
Divorce
a History of Severe Mental Illness
having severe illness Such as Cancer
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Among those who were willing to participate in the study, 50 subjects with higher scores in the Marital Stress Questionnaire and lower scores the Sexual Function Questionnaire were selected .then Subject are Divided in two Groups Randomly . Including 50 subject Experimental group (25subject)and Control Group(25subject) .
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
Shahid Sadoughi University of Medical Sciences and Health Services
Street address
Sahid Bahonar sq, Central department of Shahid Sadoughi University of Medical Sciences and Health Services'Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.SSU.REC.1395.193
Health conditions studied
1
Description of health condition studied
Sexual Function
ICD-10 code
F66.2
ICD-10 code description
Sexual Relationship Disorder
2
Description of health condition studied
Marital Stress
ICD-10 code
Z63.0,Z63.
ICD-10 code description
Problems in Relationship With Spouse or Partner
Primary outcomes
1
Description
Marital Stress
Timepoint
Before Intervention, in Eighth Week of Intervention, Four Week after Finish Workshop
Method of measurement
Marital Stress Questioner ESTM
2
Description
Sexual Function
Timepoint
Before Intervention, in Eighth week of Intervention, Four Week after Finish Workshop
Method of measurement
Sexual Function Questioner
Secondary outcomes
1
Description
Mindfulness
Timepoint
First Of Study and in end of Study (Eighth Week)
Method of measurement
Mindfulness Questioner
Intervention groups
1
Description
Intervention Group Have 90 Minutes Workshop Once a Week That Continue 8 Week and Control Group Do Not Have Intervention .
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Reserch Center and Clinics
Full name of responsible person
Dr Masoud Rahmanian, Endocrinologist
Street address
Bahonar sq, Yazd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
DRC@SSU.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ALI SALARI
Street address
Yazd, Safaieh Nursingand Midwifery School
City
YAZD
Province
Yazd
Postal code
916877443
Phone
+98 35 3824 1751
Email
MICROB_50@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
ferdows mohammadalian
Position
MSc Student Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Sadoughi University of Medical Sciences, Alem Sq, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916998949
Phone
+98 35 3824 1757
Fax
Email
FSMDAN1393@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Ph.D in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, Safaieh Nursing and Midwifery School,Yazd Department of Midwifery
City
Yazd
Province
Yazd
Postal code
916877443
Phone
+98 35 3824 1751
Fax
Email
MAH-BOKAIE@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ferdows Mohammadalian
Position
MSc Student Counseling in Midwifery Nursing and Midwifery School, Department of Midwifery, Shahid Sa
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, Safaieh Nursingand Midwifery School,Yazd
City
YAZD
Province
Yazd
Postal code
8916998949
Phone
+98 35 3824 1751
Fax
Email
FSMDAN1393@GMAIL.COME
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
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