Investigating the effect of counseling based on problem-solving therapy on sexual function of women undergoing complete abdominal hysterectomy by virtual group method
Determining the effect of problem-solving counseling on sexual function in women who have undergone complete abdominal hysterectomy
Design
A parallel clinical trial with control group, block randomized without blinding by referring to the online site of random allocation on 60 patients
Settings and conduct
Location: Yazd Social Security Hospital. The female sexual function questionnaire is filled in at the beginning, eight and twelve weeks after the start of the study by the intervention and control group. Classes will be done virtually by installing one of the authorized messaging software. People ask their questions in the form of online chat and receive the necessary advice. It is possible to chat privately and send SMS after class.
Participants/Inclusion and exclusion criteria
Entry requirements: Smartphone access; Maximum 55 years; Complete abdominal hysterectomy due to benign disease; Three months to a year after the hysterectomy; Living in the same house with your spouse and not intending to divorce; The only wife of her husband. No entry conditions: Participate in simultaneous psychological and psychiatric interventions; Consumption of psychiatric drugs according to the patient; Addiction of yourself or your spouse according to the patient; Use of hormone replacement therapy
Intervention groups
The intervention group undergoes virtual sexual function training with a problem-solving approach in eight ninety-minute sessions. The control group receives male and female genital anatomy training and sexual response cycle as a pamphlet. , and after the intervention, they are consulted if they wish.
Main outcome variables
Women's sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220601055048N1
Registration date:2022-06-12, 1401/03/22
Registration timing:prospective
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
Faeghe Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8104
Email address
f.dehghan@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of counseling based on problem-solving therapy on sexual function of women undergoing complete abdominal hysterectomy by virtual group method
Public title
The effect of virtual group counseling with problem solving approach on sexual function of women who have had hysterectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing
Smartphone and Internet access
Maximum 55 years
Complete abdominal hysterectomy
Hysterectomy due to benign disease
Three months to a year after the hysterectomy
Live in the same house with their spouse during the research period and do not intend to divorce
The only wife of her husband
Exclusion criteria:
Participate in simultaneous psychological and psychiatric interventions
Taking psychiatric medication to the person's own expression
Addiction of the person or spouse to the person's own expression
Use of hormone replacement therapy
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization by visiting the random allocation online site:
The sample size consists of 60 women, who are assigned a number for each woman by visiting the online site of random allocation. Then each sample is randomly assigned to one of the two treatment groups A and B through the blocks available at http://randomization.com. This means that the allocation of samples to each of the two groups does not occur in A and B, respectively, but in the order in which the software output is placed.
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
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services, Shahid Dr. Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.SSU.REC.1400.254
Health conditions studied
1
Description of health condition studied
Sexual function of women undergoing complete abdominal hysterectomy due to benign disease
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
Women's sexual function score, which is measured by the Mohammadi Women's Sexual Function Questionnaire.
Timepoint
Calculation of female sexual function score at the beginning of the study (before the intervention), eight and twelve weeks after the start of the study
Method of measurement
Using Mohammadi et al.'s questionnaire, women's sexual function is measured in six areas. A higher score indicates better sexual performance.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives counseling based on the problem-solving treatment on sexual function online or offline through the mobile social application channel. Meetings are once a week for 90 minutes and a total of 8 sessions.
Category
Treatment - Other
2
Description
Control group: The control group receives the anatomy training of the male and female reproductive system and the sexual response cycle in the form of a pamphlet, and after the intervention, it is consulted if desired.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye kargar (Social Security) hospital, Yazd
Full name of responsible person
Ali Paydar
Street address
Namaz Sq., Modares Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
8915451135
Phone
+98 35 3182 2000
Fax
Email
shohadakargar.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
International Branch of Shahid Sadoughi University of Medical Sciences and Health Services,Yazd, km 5 of Bafgh Old Road, Yazd
City
Yazd
Province
Yazd
Postal code
8944158318
Phone
+98 35 3836 7634
Email
international@ssu.ac.ir
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
Dr. Mahshid Bakaie
Position
PhD in Reproductive Health, Faculty Member and Director of Midwifery Counseling Group
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing, Bouali Alley, Timsar Fallahi St., Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
Email
mah_bokaie@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, Faculty Member and Director of Midwifery Counseling Group
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing, Bouali Alley, Timsar Fallahi St., Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
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
Dr. Mahshid Bokaie
Position
PhD in Reproductive Health, Faculty Member and Director of Midwifery Counseling Group
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Midwifery Nursing, Bouali Alley, Timsar Fallahi St., Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916878397
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
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