The effectiveness of PLISSIT, a sexual counseling model on sexual function and sexual adaption of women with spinal codr injury refered to Brain and spinal injury Repair Research Center(BASIR), Institution of Neouroscience
Spinal cord injury is a common disability around the world and is a terrible event for patient, family and community. This situation can effect on several aspects of the patients including sexual life. Sexual dysfunctions following spinal cord injury usually occur due to autonomous sensory and motor nerves that may present as vaginal lubrication disturbance in women and erection disorder in men. Despite the medical treatment for the rehabilitation of patients, sexual adaption is a serious problem. Sexual adaptation in spinal cord injured patients include individual and interpersonal aspects. The aim of this study is assessment of the effectiveness of PLISSIT sexual counseling on sexual function and sexual adaption of women with spinal cord injury. This study is Randomised Clinical Trial (RCT) on 50 women with spinal cord injuries having at least one sexual problem that will be recruited purposefully. Random allocation to intervention and control groups will be done after obtaining informed consent. Intervention group will receive three 45 minute individual counseling sessions and control group just will receive routine care. The participants will be assessed for sexual function and adaptation, before, two weeks, and 8 weeks after intervention, and data collection will be done by FSFI and SAQ questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061631662N3
Registration date:2017-07-30, 1396/05/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-30, 1396/05/08
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of PLISSIT, a sexual counseling model on sexual function and sexual adaption of women with spinal codr injury refered to Brain and spinal injury Repair Research Center(BASIR), Institution of Neouroscience
Public title
The effectiveness of PLISSIT, a sexual counseling model on sexual function and sexual adaption of women with spinal codr injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: participating in sessions regularly; having sexual activity; incomplete spinal cord injury; ability to read and write; to be available in the future month; having Iranian nationality; not having sexual disorder and chronic disease in partner.
Exclusion criteria: become pregnant; marriage conflicts; occurring bitter events (death,...); well-known disease influence on sexual function; use some drugs that influence on sexual function.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
North Takeghani-Azimiyeh
City
Karaj
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.ABZUMS.REC.1396.5
Health conditions studied
1
Description of health condition studied
Spinal cord injury
ICD-10 code
G80-G83
ICD-10 code description
Cerebral palsy and other paralytic syndromes
Primary outcomes
1
Description
Sexual function
Timepoint
Before, 4 weeks , and 8 weeks after intervention
Method of measurement
FSFI questionnaire
2
Description
Sexual adaptation
Timepoint
Before, 4 weeks , and 8 weeks after intervention
Method of measurement
SAQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive three 45 minute PLISSIT based (the first three stages) individual sexual counseling sessions weekly.
Stage1: Permission
Stage 2: Limited information
Stage3: Specific suggestions
Category
Behavior
2
Description
The control group will receive routine care (an educational pamphlet ).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Spinal injury Repair Research Center (BASIR)-TUMS
Full name of responsible person
Mona Rezaei Fard
Street address
Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
North Taleghani street-Azimyeh
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences- School of Nursing and Midwifery
Full name of responsible person
Razieh Lotfi
Position
PhD.
Other areas of specialty/work
Street address
1st Golestan-Eshteraki Boulevard-Baghestan-Karaj
City
Karaj
Postal code
Phone
+98 26 3430 4433
Fax
Email
raziehlotfi@abzums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery-Alborz University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
PhD.
Other areas of specialty/work
Street address
1st Golestan street-Eshteraki Boulevard-Baghestan
City
Karaj
Postal code
Phone
+98 26 3430 4433
Fax
Email
raziehlotfi@abzums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery- Alborz University of Medical Sciences
Full name of responsible person
Mona Rezaei fard
Position
BSc.
Other areas of specialty/work
Street address
1st Golestan- Eshteraki Boulevard- Baghestan
City
Karaj
Postal code
Phone
+98 26 3430 4433
Fax
Email
raziehlotfi@abzums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)