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Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes

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History
# Registration date Revision Id
2 2025-02-07, 1403/11/19 330353
1 2024-05-10, 1403/02/21 301293
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  • Protocol summary

    Determining the effect of couples relationship enhancement counseling on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    Determining the effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    تعیین تاثیر مشاوره غنی‌سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو
    تعیین تاثیر برنامه مشاوره غنی‌سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو

  • General information

    empty
    The word 'program' was missing in the title, and the word 'counseling' was translated as 'training' in English. Therefore, the title has been revised accordingly.
    empty
    در عنوان کلمه "برنامه" فراموش شده بود و همچنین کلمه "مشاوره" در ترجمه انگلیسی "آموزش" ترجمه شده است. به همبن دلیل عنوان مجدد ویرایش شد.
    Effect of couples relationship enhancement training on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    تاثیر مشاوره غنی سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو
    تاثیر برنامه مشاوره غنی سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو
    Effect of couples relationship enhancement training on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
    تاثیر مشاوره غنی‌سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو
    تاثیر برنامه مشاوره غنی‌سازی روابط زوجین بر عملکرد جنسی، کیفیت زندگی جنسی و رضایت جنسی زنان مبتلا به دیابت نوع دو

  • Recruitment centers

    #1
    Name of recruitment center - English: Mehrgan clinic in Qom city and Seyyed al-Shohda (Shahid Hinduyan ) clinic
    Name of recruitment center - Persian: درمانگاه مهرگان شهر قم و درمانگاه سیدالشهدا (شهید هندویان)
    Full name of responsible person - English: Zohre Khalajinia
    Full name of responsible person - Persian: زهره خلجی نیا
    Street address - English: School of Nursing and Midwifery; East No 2 Alley; Moalem Blvd; Qom
    Street address - Persian: قم؛ بلوار معلم؛ کوچه شماره 2 شرقی؛ دانشکده پرستاری مامایی
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3715835155
    Phone: +98 912 251 6033
    Fax:
    Email: zkh6033@yahoo.com
    Web page address:
    Name of recruitment center - English: Seyyed al-Shohda (Shahid Hinduyan ) clinic
    Name of recruitment center - Persian: درمانگاه سیدالشهدا (شهید هندویان)
    Full name of responsible person - English: Amir Hossein Mantazer
    Full name of responsible person - Persian: امیر حسین منتظر
    Street address - English: Qom - 7 Tir Street - between 12th and 14th alley - in front of Tejarat Bank - Shahid Hinduyan Building
    Street address - Persian: قم -خیابان 7 تیر - بین کوچه 12 و 14 - مقابل بانک تجارت - ساختمان شهید هندویان
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3715835155
    Phone: +98 25 3670 8545
    Fax:
    Email: zkh6033@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohre Khalajinia
    Full name of responsible person - Persian: زهره خلجی نیا
    Street address - English: School of Nursing and Midwifery; East No 2 Alley; Moalem Blvd; Qom
    Street address - Persian: قم؛ بلوار معلم؛ کوچه شماره 2 شرقی؛ دانشکده پرستاری مامایی
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3715835155
    Phone: +98 912 251 6033
    Fax:
    Email: zkh6033@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rahim Aali
    Full name of responsible person - Persian: رحیم عالی
    Street address - English: Shahid Lotfi Niaser Alley, Jahad Daneshgahi Alley, Safashehr Street
    Street address - Persian: قم -خیابان صفاشهر- کوچه جهاد دانشگاهی- کوچه شهید لطفی نیاسر
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3716993456
    Phone: +98 25 3285 2720
    Fax:
    Email: research@mail.muq.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
Design
Clinical trial with parallel groups, randomized on 23 couples. Simple randomization method is used for randomization.
Settings and conduct
1- Location of the study: Mehrgan diabetes association center of Qom and Seyyed al-Shohda Clinic (Shahid Hinduyan) are the research environment of this study. 2- The study population: Women with type 2 diabetes. 3- Type of blinding: due to the nature of the study, there is no possibility of blinding and only blinding of the statistician will be done.
Participants/Inclusion and exclusion criteria
23 couples in which only the woman has diabetes with the age range of 35 to 55 years will be included in the study, and women with psychiatric disorders and other chronic diseases will be excluded from the study.
Intervention groups
The first group (intervention) will be assigned to the group receiving couples relationship enhancement counseling and the second group (control) will be assigned to the group receiving regular programs.
Main outcome variables
Sexual function; sexual life quality; sexual satisfaction

General information

Reason for update
The word 'program' was missing in the title, and the word 'counseling' was translated as 'training' in English. Therefore, the title has been revised accordingly.
Acronym
IRCT registration information
IRCT registration number: IRCT20240415061491N1
Registration date: 2024-05-10, 1403/02/21
Registration timing: prospective

Last update: 2025-02-12, 1403/11/24
Update count: 1
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Azam Mohsennejad saniani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3885 2944
Email address
azammohsennejad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
Public title
Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
35 to 55 years old Being married and having a sexual partner Being literate in reading and writing At least one year has passed since their illness and they have laboratory criteria with FBS ≥ 126 or HbA1C ≥ 6.5 Good blood sugar control status (average FBS ≤ 130 mg/dL in the last three months) Having sexual activity during the last 6 months or at least six months of cohabitation People who answered positively to at least one of the questions in the sex screening form
Exclusion criteria:
Attending another study at the same time History of participating in psychological training classes aimed at improving sexual problems History of psychiatric disorders Experiencing recent crises in life Using any type of sedative, alcohol and drugs in couples History of severe marital disputes and going to court Breastfeeding Menopause History of mastectomy or complete hysterectomy History of psychiatric disorders Suffering from other acute or chronic diseases in couples (blood pressure, heart, kidney, liver and thyroid diseases) Use of oral contraceptives and corticosteroids
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to one of two study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the study, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
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
Research Ethics Committees of Qom University of Medical Sciences
Street address
School of Nursing and Midwifery, East No. 2 Alley, Moalem Blvd.
City
Qom
Province
Ghoum
Postal code
3715835155
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.MUQ.REC.1403.010

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Quality of sexual life
Timepoint
Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
Method of measurement
Women's sexual life quality questionnaire

2

Description
Sexual satisfaction
Timepoint
Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
Method of measurement
Larson's sexual satisfaction questionnaire

3

Description
Sexual performance
Timepoint
Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
Method of measurement
Women's sexual performance scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Couples relationship enrichment intervention will take place during six 90-minute sessions. The executive protocol of marital relationship enrichment sessions (RET) will be conducted in the form of couple counseling and in the presence of husband and wife, and the enrichment package will be based on similar interventions taken from two treatment books based on communication enrichment and the book of sex education sessions taken from my wife's book with comments from Specialists will be specially designed.
Category
Lifestyle

2

Description
Control group: The control group receives only the usual treatments.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyyed al-Shohda (Shahid Hinduyan ) clinic
Full name of responsible person
Amir Hossein Mantazer
Street address
Qom - 7 Tir Street - between 12th and 14th alley - in front of Tejarat Bank - Shahid Hinduyan Building
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3670 8545
Fax
Email
zkh6033@yahoo.com

2

Recruitment center
Name of recruitment center
Mehrgan clinic in Qom city
Full name of responsible person
Ali Ziyai
Street address
Qom, at the end of Inghelab Street (Char Mardan), 48 Alley
City
Qom
Province
Ghoum
Postal code
3715856791
Phone
+98 25 3760 2212
Fax
Email
zkh6033@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
Shahid Lotfi Niaser Alley, Jahad Daneshgahi Alley, Safashehr Street
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
research@mail.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, East No. 2 Alley, Moalem Blvd.
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3778 0001
Email
zkh6033@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, East No. 2 Alley, Moalem Blvd.
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3778 0001
Email
zkh6033@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Khalajinia
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, East No. 2 Alley, Moalem Blvd.
City
Qom
Province
Ghoum
Postal code
3715835155
Phone
+98 25 3778 0001
Email
zkh6033@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Still undecided - no release schedule yet
When the data will become available and for how long
Still undecided - no release schedule yet
To whom data/document is available
People working in scientific and research institutions
Under which criteria data/document could be used
If all group members agree, the file can be accessed.
From where data/document is obtainable
Dr Zohre Khalajinia
What processes are involved for a request to access data/document
The applicant should send an email to Dr. Khaljinia. It will be sent if agreed.
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