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Investigating the effect of psycho-sexual counseling based on the Schover model on the Sexual self-concept and sexual distress of hysterectomy women

Protocol summary

Study aim
Determining the effect of psychological-sexual counseling on sexual self-concept and sexual distress of hysterectomized women
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 100 patients. Hundreds of envelopes are placed inside the box for random allocation.
Settings and conduct
Using the random allocation method, two test and control groups are divided. One hundred envelopes are placed in the box, 50 of them will enter the intervention group if they choose the envelope containing the number 1, and 50 will enter the control group if the envelope contains the number 2. Counseling will be given to the intervention group during 4 weekly sessions at Kausar Medical Training Center, and the concerns and questions of the participants will be answered in these sessions. At the end, the control group is given a booklet of necessary training that was given to the intervention group.
Participants/Inclusion and exclusion criteria
Hysterectomy due to benign indications, Not menopausal, married, Absence of vaginismus, No addiction, satisfaction, Reluctance to continue,
Intervention groups
The intervention group will be given weekly sexual counseling during 4 sessions, in these sessions the challenges, concerns and questions of the participants will be answered. At the end, the control group is given a booklet of necessary training that was given to the intervention group.
Main outcome variables
Sexual self-concept and sexual distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230507058109N1
Registration date: 2023-07-15, 1402/04/24
Registration timing: retrospective

Last update: 2023-07-15, 1402/04/24
Update count: 0
Registration date
2023-07-15, 1402/04/24
Registrant information
Name
Zeinab Maloum
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3552 1720
Email address
zeinab.maloom75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-19, 1402/02/29
Expected recruitment end date
2023-05-26, 1402/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of psycho-sexual counseling based on the Schover model on the Sexual self-concept and sexual distress of hysterectomy women
Public title
Investigating the effect of psycho-sexual counseling based on the Schover model on the Sexual self-concept and sexual distress of hysterectomy women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Be of reproductive age (18-49 years old) 6-3 months have passed since hysterectomy Subtotal and total hysterectomy without oophorectomy Have not gone through menopause before hysterectomy Be married and living His partnership with his wife should continue (not about to divorce) Not having chronic diseases such as mental disorders, physical disabilities, AIDS and hepatitis according to the patients themselves Hysterectomy due to benign indications Having at least one child Do not have vaginitis Do not have a history of vaginismus No addiction to psychoactive drugs or narcotics in couples
Exclusion criteria:
1- Absence of consent Participant does not want to continue the study Absence of even one of the counseling sessions Participant attends educational or sexual counseling sessions outside the study environment
Age
From 18 years old to 49 months old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random allocation method (envelope), the final participants are divided into two test groups (50 people) and control (50 people). For random allocation, 100 envelopes are placed inside the box, 50 of these envelopes contain the number 1 and the other 50 contain the number 2. The participants choose one of the envelopes in the pack, if they choose the envelope containing the number 1. Enter the intervention group and if the envelope contains the number 2, enter the control group.
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 Urmia University of Medical Sciences
Street address
Zakir St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Approval date
2023-05-19, 1402/02/29
Ethics committee reference number
IR.UMSU.REC.1402.025

Health conditions studied

1

Description of health condition studied
Hysterectomy women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual self-concept
Timepoint
Before and one month after the intervention
Method of measurement
Sexual self-concept questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: hysterectomized women, psycho-sexual counseling based on the Skover model during 4 weekly sessions of 90-120 minutes, the content of these sessions will include: evaluation of activity, performance and sexual relations, evaluation of concomitant diseases, mental , disabilities and examining the skills to deal with these challenges and treatments received.. Also, hysterectomy description and psychological and sexual consequences, examination of common sexual problems after hysterectomy (decrease in the frequency of sexual activity, decrease in vaginal moisture, decrease in sexual satisfaction, decrease Sexual desire and stimulation, inability to reach orgasm, pain during intercourse, change in sensation (numbness, pain or itching), change in reaching orgasm after hysterectomy, change in body function or mental image of the body following removal of the uterus, complications side related to disease or treatment), assessment of common psychological factors after hysterectomy (distorted body image, anxiety, depression, anger, impaired sense of femininity following loss of uterus and fertility, fear of injury and loss Other organs or exacerbation of the current situation, lack of coping skills, history of sexual, emotional or psychological abuse in the past, wrong cultural-social beliefs and superstitions of pre-existing sexual patterns), familiarity with sexual function and internal and external male organs and Woman, getting to know the pattern of sexual response, describing the physiological changes of men and women during sexual activity, definitions of sexual desire, arousal, slippage, climactic climax, answering possible questions of clients, evaluating communication factors after hysterectomy (change in personal or professional roles E. Difficulties in communication, decrease in the quality of communication with a life partner, difficulty in maintaining intimacy, lack of a life partner, social determinants in relation to self-care (recommendation from others), lack of suitable conditions for establishing a private environment based on life conditions. - Clarifying and clarifying expectations, correcting misconceptions and superstitions about sex, techniques for writing down needs and expectations from sex, solutions to deal with psychological-sexual changes after surgery - providing necessary information and training about sensory focus techniques, Advice on stretching exercises and pelvic floor exercises to improve sexual function, suitable positions to reduce pain during intercourse, ways to reduce vaginal irritation and irritation, available treatments to reduce vaginal dryness and urinary incontinence, nutritional recommendations, sleep hygiene education and performing stretching and sports exercises and recommending daily walks, sleep and bedroom hygiene, explaining the components of Sternberg's love triangle - explaining the role of commitment, love and intimacy in an effective relationship with a spouse, familiarizing and emphasizing the importance of flirting and behaviors after marriage Intercourse, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance of flirting and making love, examining the determining factors in the quality of relationships, teaching creation skills and maintaining intimacy (counseling to improve the way of talking, listening empathetically and sharing feelings in creating intimacy), finding the roots of situational/pervasive sexual desire reduction and providing a solution.. It should be noted that the content of counseling and providing information during group counseling will be advanced based on the needs and demands of the group members.
Category
Lifestyle

2

Description
Control group: Hysterectomy women, these people are not given any counseling, but after the end of the intervention, an educational package is provided to them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar educational and therapeutic center
Full name of responsible person
Zeinab Maloum
Street address
Zakir St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 939 800 7443
Email
zeinab.maloom75@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saber Gholi Zade
Street address
Zaker St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 939 800 7443
Email
zeinab.maloom75@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Zeinab Maloum
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zaker St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 939 800 7443
Email
zeinab.maloom75@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zeinab Maloum
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zaker
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 61 3552 1720
Fax
Email
zeinab.maloom75@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zeinab Maloum
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zaker
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 61 3552 1720
Email
zeinab.maloom75@yahoo.com

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
Only part of the data is shared
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
For research work
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Email me
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