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The impact of online solution-focused group counseling on the sexual quality of life and marital adjustment of women after hysterectomy

Protocol summary

Study aim
Determining the effect of Online Solution-Focused Group Counseling on Sexual Quality of Life and Marital Adjustment in Women After Hysterectomy
Design
This is a randomized, unblinded, parallel-group, controlled clinical trial conducted on 104 patients. The randomization was performed using the website https://www.sealedenvelope.com.
Settings and conduct
Sessions will be held via Google Meet over a period of 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Hysterectomy for benign reasons 2. Married and sexually active 3. Having just one partner 4. Within 2 months to 1 year post-surgery 5. Access to internet and communication tools 6. Not using hormone replacement therapy 7. Not receiving other educational programs 8. Not taking psychiatric medications 9. No history of mental illness 10. No medical conditions 11. No experience of traumatic or stressful events in the past six months 12. Sexual Quality of Life score less than 80 or Marital Adjustment score less than 100 Exclusion Criteria: 1. Unwillingness to continue participation 2. Absence from more than one session 3. Failure to complete assignments for more than two sessions 4. Experiencing severe stressful events during the study
Intervention groups
The intervention group will receive six online sessions of solution-focused counseling. These sessions will utilize solution-focused principles to investigate the impact of solution-focused counseling on sexual quality of life and marital adjustment in women after hysterectomy. The control group will receive their usual services and will receive the study's educational and counseling package at the end of the study.
Main outcome variables
Sexual Quality of Life After Hysterectomy Marital Adjustment After Hysterectomy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240601061975N1
Registration date: 2024-06-08, 1403/03/19
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Mohadese Farahmandnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6730
Email address
farahmandniam4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of online solution-focused group counseling on the sexual quality of life and marital adjustment of women after hysterectomy
Public title
The impact of online solution-focused group counseling on the sexual quality of life and marital adjustment of women after hysterectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Hysterectomy for benign reasons (bleeding, mass, prolapse, pelvic pain, and adenomyosis) Being married and sexually active Having just one partner Being within 2 months to one year post-operation Having access to the internet and communication tools Not using hormonal replacement therapy (HRT) Not receiving other educational programs Not consuming psychiatric drugs No history of mental illness Absence of medical conditions (cardiac disorders, high blood pressure, respiratory diseases, thyroid disorders, epilepsy, overt diabetes) No recent experience of stressful and unpleasant events in the past six months (serious illness of self or immediate family members, death of a loved one, accidents, severe family conflicts, divorce, migration, expulsion, unemployment, bankruptcy) Quality of sexual life score less than 80 or marital adjustment score less than 100
Exclusion criteria:
Unwillingness to continue the collaboration Absence from more than one session Failure to complete assignments for more than two sessions Experiencing significant stressful events during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to study groups using a block randomization method with block sizes of 2 and 4. This will be done using the website https://www.sealedenvelope.com/.
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 School of Nursing & Midwifery - Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Khwarazmi Complex, School of Nursing and Midwifery, 2nd Floor, Room C26
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-05-14, 1403/02/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.016

Health conditions studied

1

Description of health condition studied
Sexual Quality of Life After Hysterectomy, Marital Adjustment After Hysterectomy
ICD-10 code
(http://ap
ICD-10 code description
Z90.7Acquired absence of genital organ(s)F52.1Sexual aversion and lack of sexual enjoymentZ70.0Counselling related to sexual attitudeZ70.1Counselling related to patient's sexual behaviour and orientationZ70.8Other sex counsellingZ71.8Other specified couns

Primary outcomes

1

Description
Changes in the Average Scores of Individuals on the Simon's Sexual Quality of Life Questionnaire for Women
Timepoint
At the beginning of the study, immediately and one month after the completion of the consultation sessions.
Method of measurement
Simon's Sexual Quality of Life Questionnaire

2

Description
Changes in Average Marital Adjustment Scores of Spouses
Timepoint
At the beginning of the study, immediately and one month after the completion of the consultation sessions.
Method of measurement
Dyadic adjustment scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive 6 online coaching sessions based on the Solution-Focused approach.
Category
Lifestyle

2

Description
Control group: It does not receive any intervention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Majid Hosseini
Street address
Ibn Sina Street, Imam Reza Hospital Square, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir/

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Gholamali Mamouri
Street address
Ahmadabad Street, Ghaem Hospital, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
b.qhaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fateme Hajiabadi
Street address
Azadi Square, Eastern Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Khwarazmi Educational Complex, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Web page address
https://nurse.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Zahra Hadizade Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Azadi Square, Eastern Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Khwarazmi Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
hadizadehz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Zahra Hadizade Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Azadi Square, Eastern Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Khwarazmi Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
hadizadehz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadese Farahmandnia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad University of Medical Sciences Dormitory, Baharestan 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3884 6730
Fax
Email
farahmandniam4012@mums.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
The study data includes sexual quality of life scores, marital adjustment scores, demographic characteristics, and information related to hysterectomy awareness questionnaires. This data will be reported solely as numbers and average scores; the names of participants will remain confidential with the researcher.
When the data will become available and for how long
Access will begin, along with the printing of related research papers.
To whom data/document is available
The thesis will be accessible to medical researchers and students in Mashhad, and related articles will be available to all researchers.
Under which criteria data/document could be used
Individuals affiliated with scientific organizations and institutions may use this material for their research, upon request and with proper attribution and referencing of the relevant study.
From where data/document is obtainable
Contact the responsible author via email.
What processes are involved for a request to access data/document
After receiving an applicant's email, which includes their introduction and type of request, the responsible writer will review the necessary information and send it to the applicant as soon as possible.
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