Protocol summary

Study aim
Determining the effect of counseling with a positive approach on sexual satisfaction and marital satisfaction of women of childbearing age in the COVID-19 pandemic
Design
A single blind RCT study on 72 women of childbearing age (36 in the intervention group and 36 in the control group) in which participants will be divided into two groups receiving the consultation and the control groups using the website www.random.org through block randomization with blocks of size four and six and the 1: 1 allocation ratio.
Settings and conduct
Sampling will be done from Tabriz health centers. Participants will complete the Anxiety, Sexual Satisfaction and Marital Satisfaction Questionnaires before the intervention and 4 weeks after the end of the counseling sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Marriage; Being sexually active; Score 43 to 53 in anxiety; Sexual satisfaction score less than 100; Failure to receive individual counseling services during the study. Non-inclusion criteria: history of physical illnesses affecting sexual desire (disability, chronic physical illness such as MS); Cancer, stressful variables such as illness of a family member (cancer) or death of a first-degree family; Having mental illness in patient, his spouse or a family member according to the patient statement
Intervention groups
Intervention group: Receiving counseling with a positive psychology approach will be done during 8 90-minute group counseling sessions. Control group: There will also be a counseling session on methods of preventing sexually transmitted diseases.
Main outcome variables
Sexual satisfaction, marital satisfaction, latent and overt anxiety score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171007036615N8
Registration date: 2021-11-28, 1400/09/07
Registration timing: registered_while_recruiting

Last update: 2021-11-28, 1400/09/07
Update count: 0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Positive psychology (optimistic) based Counseling on Sexual and Marital Satisfaction among Reproductive Aged Women during Corona Pandemic: A randomized controlled clinical trial
Public title
The Effect of Positive psychology (optimistic) based Counseling on Sexual and Marital Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married and the spouse be alive Being sexually active Get a score of 43 to 53 in anxiety Sexual satisfaction score less than 100 Not receiving individual counseling services during participation in treatment sessions
Exclusion criteria:
Having a history of physical illnesses affecting sexual desire (having organ damage, having a chronic physical illness) Presence of physical and debilitating diseases such as cancer, MS and ... Stressful variables such as disability or illness of a family member (cancer, retardation, etc.) Mental illness of the patient, spouse or family member according to the patient report Occurrence of recent traumatic events and acute stressful problems such as the death of a first-degree family in recent months (death of child, father, etc.) Smoking, alcohol and drugs and other drugs that affect the body and mind Use of drugs that reduce sexual desire (antidepressants: fluoxetine, sertraline, paroxetine. Antihistamines: chlorpheniramine, drugs that affect blood pressure: clonidine, captopril, benzodiazepines such as alprazolam (Xanax) and .... Premature menopause Marital disputes affecting sexual relations (severe marital disputes that have led to divorce petitions)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into two groups using the website www.random.org and through random blocking with blocks of four and six and a ratio of 1: 1 to two groups (group receiving counseling and control group) Blocking will be done by a person not involved in sampling and data analysis. To hide the allocation, the type of intervention will be written on paper and placed inside the consecutively numbered envelopes (Allocation Concealment). The envelopes will be opened in order of entry of participants by the person not involved in sampling.
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 Tabriz University of Medical Sciences
Street address
Tabriz college of Nursing and Midwifery, South Shariati St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-08-26, 1400/06/04
Ethics committee reference number
IR.TBZMED.REC.1400.677

Health conditions studied

1

Description of health condition studied
Sexual and Marital Satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Apparent and covert anxiety score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Spielberger Anxiety questioner

2

Description
Sexual satisfaction score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Larson questioner

3

Description
Marital satisfaction
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Enrich questioner

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 8 90-minute sessions of positivity-based counseling with the content of appreciation, communication techniques, forgiveness, positive thinking, positive and effective communication, emphasis on individual abilities, etc. will be done in face-to-face and virtual group sessions.
Category
Behavior

2

Description
Control group: A contraceptive counseling session will be held for an average of 60-90 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Teymouri Health Center
Full name of responsible person
Dr. Kolsoom Masoumi Jarchloo
Street address
Behind Jihad Keshavarzi, Amirkabir alley, not far from Firooz alley, Laleh intersection, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3443 8061
Email
mahdiearab1376@gmail.com

2

Recruitment center
Name of recruitment center
Marandian Health Center
Full name of responsible person
Dr. Laleh Sadeghi
Street address
Haj Ghaffar Alley, old 17 Shahrivar St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3555 3015
Email
mahdiearab1376@gmail.com

3

Recruitment center
Name of recruitment center
Eram Health Center
Full name of responsible person
Dr. Elham Gholamalipour
Street address
Al-Mahdi Street, District 8, Eram Town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3232 5127
Email
mahdiearab1376@gmail.com

4

Recruitment center
Name of recruitment center
Manzaria Health Center
Full name of responsible person
Dr. Mohammad Reza Mohammad Alizadeh Niazi
Street address
Etesami Alley, Abadani Maskan, Abu Rihan Crossroads, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 2334
Email
mahdiearab1376@gmail.com

5

Recruitment center
Name of recruitment center
Shahid Monampour Health Center
Full name of responsible person
Dr Ali Agahi
Street address
Saffron, Saffron Bazaar
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3331 8281
Email
mahdiearab1376@gmail.com

6

Recruitment center
Name of recruitment center
Ibn Sina Health Center
Full name of responsible person
Dr. Ahmad Namdari
Street address
in front of Imam Hossein Mosque, 18 meters from Idem, Taleghani town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6151
Email
mahdiearab1376@gmail.com

7

Recruitment center
Name of recruitment center
Noor Health Center
Full name of responsible person
Dr. Hamid Mottaghi Khosroshahi
Street address
8th Negarestan St. (Fajr), Noor Town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3448 5638
Email
mahdiearab1376@gmail.com

8

Recruitment center
Name of recruitment center
Shahid Yahyawi Health Center
Full name of responsible person
Dr. Mahtab Montazer Bavil Aliai
Street address
Azadi St., Shahid Jediri St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3334 0444
Email
mahdiearab1376@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Vice Chancellor for Technology Research, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mahdiearab1376@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
b.mehrabi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
b.mehrabi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
b.mehrabi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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