Determining the effectiveness of sexual rehabilitation training on anxiety and sexual satisfaction of women with spinal cord injuries
Design
In this study, the type of research is quasi-experimental with the control group. The sampling method is continuous and then randomly to be placed in two groups of control and intervention and the sample size in each group is 50 people. Data collection before and one Will be performed one month after the intervention.
Settings and conduct
The population of this study will be all people with spinal cord injuries who refer to the Iranian Spinal Cord Injury Support Association. And will include an introductory session and 2 training sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria of Women with spinal cord injuries:
Age 18 to 55 years
No underlying diseases
Having literacy
Lack of psychological diseases
Do not use drugs
Passing the spinal shock stage
Willingness to participate in the study
Exclusion criteria:
Absence from attending training sessions
Death of the patient
Intervention groups
Training intervention using video is based on a booklet that includes topics introducing spinal cord injury/sexual disorders caused by spinal cord injury/body image after the lesion and its recovery/regulation of bladder and intestinal activity/prevention of pressure ulcers/pain management/Spasticity/Appropriate environment/Time of use and side effects of medications and personal hygiene. In order to maintain ethics, the booklet will be given to the control group at the end of the intervention.
Main outcome variables
Anxiety is an adaptive reaction to the occurrence of coping behaviors to face potential risks and in this study, is based on the score obtained from the BAI.
Sexual satisfaction is the degree to which people are satisfied with their sexual activity. In this study, sexual satisfaction is the score of Larson Sexual Satisfaction Q.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210915052483N1
Registration date:2022-05-23, 1401/03/02
Registration timing:retrospective
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
mahsa soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3378 1332
Email address
mahsasoli74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
2021-10-25, 1400/08/03
Actual recruitment end date
2022-03-01, 1400/12/10
Trial completion date
2022-03-01, 1400/12/10
Scientific title
Evaluation of the effect of sexual rehabilitation training on anxiety and sexual satisfaction of spinal cord injury women
Public title
sexual rehabilitation training of women with spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 years old
Not having underlying diseases such as heart and lung diseases
Having literacy (if not literate, having a literate caregiver present in the patient's cognitive rehabilitation process)
Not having psychological illnesses According to the patient's statements
not using drugs
Passing the stage of spinal shock (having muscle tone and deep tendon reflexes)
Willingness to participate in the study
Exclusion criteria:
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:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
تThe allocation of samples to the two groups will be randomly using Random allocation software. In this way, in addition to simple randomization, this software is also able to generate a random sequence by blocking method, which is the good for our study because the sample size of intervention and control group is the same.
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 Iran University of Medical Sciences
Street address
13th floor, Block A,Central Headquarters of the Ministry of Health, Treatment and Medical Education, Iran TV Street, Ghods Town (West) - between South Flamek and Zarafshan,
City
Tehran
Province
Tehran
Postal code
1965441874
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.IUMS.REC.1400.399
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety is measured by the Beck Anxiety Inventory. A score of 0 to 21, a sign of very mild anxiety 22 to 35 indicates moderate anxiety and above 36 severe anxiety .Sexual satisfaction will be measured by the Larson Sexual Satisfaction Questionnaire. A score less than 50 indicates sexual dissatisfaction, 51-75 indicates low satisfaction, 76-100 indicates moderate satisfaction, and more than 100 indicates high sexual satisfaction.
Timepoint
Data collection will be done before and one month after the intervention.
Method of measurement
In this study, anxiety will be measured with Beck Anxiety Inventory and sexual satisfaction will be measured with Larson Sexual Satisfaction Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Control group:
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
protection center of spinal cord disables of Iran
Full name of responsible person
Ali zarrabi
Street address
Rehabilitation and Training Center for the Spinal Cord Injured of Jalaipour Martyrs, in front of Drapery Bazaar, Atashneshani St, behind Shahid Akbarabadi Hospital, Molavi St
City
Tehran
Province
Tehran
Postal code
1168753991
Phone
+98 21 5598 0650
Email
info@irannokhaa.ir
Web page address
https://www.irannokhaa.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hosein Keivani
Street address
fifth floor of the headquarters, Iran University of Medical Sciences, Hemmat Highway next to Milad Tower,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Fax
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadayi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran School of Nursing and Midwifery, Rashid Yasemi St, above Vanak Sq, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1606
Fax
+98 21 8888 2885
Email
Seyedoshohadaee.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadayi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran School of Nursing and Midwifery, Rashid Yasemi St, above Vanak Sq, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1606
Email
Seyedoshohadaee.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadayi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran School of Nursing and Midwifery, Rashid Yasemi St, above Vanak Sq, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1606
Fax
+98 21 8888 2885
Email
Seyedoshohadaee.m@iums.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
Undecided - It is not yet known if there will be 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
All data from the information of the questionnaires filled out by the participants, including the demographic questionnaire, Beck Anxiety Questionnaire and Larson Sexual Satisfaction Questionnaire, and the analysis of the answers as well as the informed satisfaction filled out by the participants are possible without mentioning the participants' information.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The use of documentation in similar studies is permitted.