Determining the effect of online narrative therapy on the mental image of the reproductive system in infertile women
Design
A randomized controlled trial of phase 3 on 64 infertile women. Excel software rand function was used for randomization.
Settings and conduct
First, a list of infertile women will extract from the gynecologist's and family physician's offices. At this stage, a checklist containing the inclusion and exclusion criteria will be prepared and a telephone call will be made to the first person from the extracted list. In case of compliance with the initial checklist and consent to participate in the project, her name will be registered in a list and the rest of the steps will be implemented. These steps will apply to everyone on the list. Next, the Genital self image will determine in these women. Then, those who have a negative Genital self image and have a score less than 23 on the Goldberg General Health Scale will include (subjects who have a score of 23 or higher refer to a psychiatrist), and finally 64 people who are eligible, after obtaining informed consent to participate in the research, enter the study. Finally, these subjects will allocate into two groups of 32 people by blocked randomization method.
Participants/Inclusion and exclusion criteria
Iranian women between the ages of 18 and 40 who are literate and live with their husbands and did not become pregnant after a year of regular and unprotected intimacy. Willing to participate in the study.
Intervention groups
In the intervention group, five 90-minute sessions in groups, the narrative therapy counseling package will be performed online. The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.
Main outcome variables
Genital self-image
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N11
Registration date:2021-11-15, 1400/08/24
Registration timing:prospective
Last update:2021-11-15, 1400/08/24
Update count:0
Registration date
2021-11-15, 1400/08/24
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-30, 1400/09/09
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of online narrative therapy and routine care on the genital self-image of infertile women.
Public title
The effect of online narrative therapy on the genital self-image of infertile women. A randomized controlled clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Having literacy and literacy
Speaking Persian
Having an age between 18-49 years
Having Primary infertility for more than one year confirmed by a gynecologist and infertility specialist
Having a smart phone and internet
getting a registered marriage
Having a written consent to participate in the research
Being generally healthy based on the Goldberg General Health Questionnaire
Exclusion criteria:
Couples' addiction to drugs and alcohol
The occurrence of a stressful accident in the past six months
Use of drugs affecting sexual function
Having obvious physical disabilities and Mentally affecting sexual function
History of pelvic surgery or radiation to the genitals
Having an adopted child
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking method will be used for random assignment of samples to two groups of 32. For this purpose, 16 blocks of four will be considered. The six possible blocks are TTCC TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in the range 0 to 6) and according to the production values of one of the blocks (for a production number between 0 to 1 CTTC block, for a production number between 1 to 2 blocks CTCT and so on) will be selected and samples will be assigned.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moallem Square, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences
City
SARI
Province
Mazandaran
Postal code
48178-57344
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.MAZUMS..REC.1400.10428
Health conditions studied
1
Description of health condition studied
Infertile women with a negative genital self image
ICD-10 code
MB27.3
ICD-10 code description
Disturbance of body image
Primary outcomes
1
Description
Genital self-image
Timepoint
Before, immediately and 45 days after the intervention
Method of measurement
Genital self-image Scale
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before, immediately and 45 days after the intervention
Method of measurement
Hudson Sexual Satisfaction Questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, 5 90-minute sessions (1 session per week) as a group, in 4 groups of 7 people and a group of 4 people, narrative therapy counseling package (compilation of therapy package based on the theory of narrative therapy and concepts and principles The theory has been narrative therapy) will be implemented online and using the WhatsApp platform, by a master student in midwifery counseling, which is supervised by a research team including: a reproductive health specialist and a PhD student in clinical psychology. It should be noted that participants prepare their narration in writing (file typed in word or handwritten photo) and send it to the researcher in privatebmessage on the WhatsApp platform. The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.
Category
Treatment - Other
2
Description
Control group: The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
gynecologist office, Sari health centers and Sari family physicians offices
Full name of responsible person
Dr Aghil Barzegar
Street address
Amir Mazandarani St. - Kargar Square - Sari Health Center
City
SARI
Province
Mazandaran
Postal code
4816711447
Phone
+98 11 3339 8913
Fax
+98 11 3339 8046
Email
fateme.shahriari.midwife@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Akbar Hedayatizadeh Imran
Street address
Moallem Square - Moallem Street - Research Center of Mazandaran University of Medical Sciences
City
SARI
Province
Mazandaran
Postal code
4816717887
Phone
+98 11 9333 3038
Email
akbar_hedayati@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghara Khani
Position
Associate Professor, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.
City
SARI
Province
Mazandaran
Postal code
4817857344
Phone
+98 11 3336 8915
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghara Khani
Position
Associate Professor, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Amir Mazandarani St. - Vesal Alley - Nasibeh School of Nursing and Midwifery
City
SARI
Province
Mazandaran
Postal code
4817857344
Phone
+98 11 3336 8915
Email
s.khani@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghara Khani
Position
Associate Professor, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Amir Mazandarani St. - Vesal Alley - Nasibeh School of Nursing and Midwifery
City
SARI
Province
Mazandaran
Postal code
4817857344
Phone
+98 11 3336 8918
Email
s.khani@mazums.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
Yes - There is 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
Research-related information is shared with the aim of keeping individuals' names and identities confidential and adhering to the 31 Code of Ethics.
When the data will become available and for how long
2022
To whom data/document is available
All researchers and research enthusiasts
Under which criteria data/document could be used
For review and supplementary research and For use by therapists of infertile women
From where data/document is obtainable
If the article is published according to the address of the magazine, you can refer to that magazine. Also, for additional information, you can access the responsible author by e-mail khanisog343@gmail.com and the e-mail of the midwifery student by e-mail fateme.shahriari.midwife@gmail.com.
What processes are involved for a request to access data/document
She /He must first send an email to the author of the article and submit her request, and if the author and the research team deem it appropriate, the documents and files will be provided in a short time.