Protocol summary

Study aim
Determining the effect of counseling approach based on admission and commitment on sexual quality of life and sexual self-efficacy in women of reproductive age
Design
Randomized clinical trial with control group
Settings and conduct
After obtaining the necessary permissions from the Research and Technology Dept. and the Ethics Committee of the University, eligible women referring to the two selected health centers of Isfahan are invited. After considering the entry and exit criteria of the study, 58 were targeted Then, according to the random numbers table, the subjects are divided into two equal groups of intervention and control. After obtaining informed consent, women's sexual quality of life questionnaires (SQOL-F) and Waziri and Lotfi's sex-self-efficacy questionnaire and demographic information questionnaire are completed by the subjects. It will consist of eight 90-minute weekly counseling sessions After completing the classes and one month later, the questionnaires were completed again and the results were analyzed using SPSS software. demographicˌ
Participants/Inclusion and exclusion criteria
The desire to participate in the study, being Iranian, living in Isfahan, age 25-40, having literacy and reading skills, married and having a spouse, the only person to be a spouse. According to the person, alcohol and drug addiction, use of drugs affecting sexual function, diseases affecting sexual function, psychiatric disorders and pregnancy.
Intervention groups
Women aged 25 to 40 are spouses
Main outcome variables
مشاوره گروهی با رویکرد اکت بر میزان خودکارآمدی جنسی وکیفیت زندگی جنسی زنان همسر دار 25تا 40 ساله تاثیر دارد

General information

Reason for update
Acronym
َACT.Acceptance Commitment Therapy
IRCT registration information
IRCT registration number: IRCT20181208041893N1
Registration date: 2019-05-13, 1398/02/23
Registration timing: retrospective

Last update: 2019-05-13, 1398/02/23
Update count: 0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Marziehsadat Rajaeizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 0520
Email address
ms.rajaeizadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-30, 1398/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Sexual Self Efficacy and Sexual Quality of Life in Reproductive age women
Public title
The Effectiveness of Acceptance and Commitment Therapy on Sexual Self Efficacy and Sexual Quality of Life in Reproductive age women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Being Iranian Resident of esfahan Age 25 - 40 years Having reading and writing skills Married and having a spouse Only being a spouse
Exclusion criteria:
Drug addiction and alcohol in themselves or in spouse According to Fred, Taking effective drugs on sexual function Diseases Affecting Sexual Function Psychiatric disorders Being pregnant
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Of the patients referred to the selected clinics of Isfahan University of Medical Sciences, 58 subjects were selected by available sampling which had the criteria for entering the study, and then, after obtaining informed consent, using the random numbers table, they would be divided into equal and equal groups of intervention and control.
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 Shahid Sadoughi University of Medical Sciences, Yazd Sciences, Translations of s
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Thaisar Fallahi Avenue، Safaiyeh،Yazd
City
yazd
Province
Yazd
Postal code
03538241757
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.SSU.REC.1397.111

Health conditions studied

1

Description of health condition studied
Sexual Self Efficacy and Sexual Quality of Life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sex quality quality score and self-efficacy score
Timepoint
Measure the quality of life quality score and self-efficacy score before and after the month after the consultation
Method of measurement
Women's Quality of Life QOL-F Questionnaire and Sexual Self-Efficacy Questionnaire (Text in Persian) Vaziri and Lotfi

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A female partner of 25 to 40 years of age who has low sexual self-efficacy and low quality of life
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Isfahan province
Full name of responsible person
Marzieh al-Sadat Rajaeizadeh
Street address
no.25 ،allay Golbaran، Bozorgmehr Ave ،22 Bahman Ave
City
ٍEsfahan
Province
Isfehan
Postal code
8158687451
Phone
+98 31 3267 0520
Email
marzirajaeizadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1757
Email
marzirajaeizadeh@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
Marzieh al-sadat Rajaeizadeh
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 38241757035
Email
marzirajaeizadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mahshid Bokaie
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 38241757035
Email
mah_bokaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Marzieh Al-sadat Rajaeizadeh
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 38241757035
Email
marzirajaeizadeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The results of the clinical study will be published as a article
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
all researchers
Under which criteria data/document could be used
Scientific use with reference to article
From where data/document is obtainable
Email:ms.rajaeizadeh@ssu.ac.ir
What processes are involved for a request to access data/document
Up to one week after correspondence by email
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