Determining the effect of progressive muscle relaxation technique on sexual dysfunction in women with multiple sclerosis in Rafsanjan city in 2023
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 80 patients, a simple lottery randomization method was used.
Settings and conduct
Obtaining a score of less than 28 from the FSFI questionnaire designed is considered as having a sexual disorder; the progressive muscle relaxation technique is one of the complementary treatments that is used as the contraction and expansion of 16 groups of muscles.
Participants/Inclusion and exclusion criteria
• Age 20-45 years
• Obtaining a score less than 28 from the FSFI questionnaire
• More than six months have passed since the diagnosis of the disease
• Married and having intermittent sex with her husband and not intending to divorce
• Extended Disability Status Scale (EDSS) score less than equal to 4.5
• Absence of pregnancy and menopause
• Not using sleeping pills, alcohol, drugs, etc.
• Non-use of common complementary treatments at the same time
• Not using any kind of sexual drugs
• Not having other chronic and acute physical and mental illnesses
• The husband's absence of known sexual disorders
• Not being in the acute stage of the disease
Intervention groups
Intervention group: performing progressive muscle relaxation on sexual performance
Control group: no intervention will be done.
Main outcome variables
Sexual performance score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230610058439N1
Registration date:2023-08-28, 1402/06/06
Registration timing:prospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Shaghayegh Azarang rooy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5801 3622
Email address
azarang98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of progressive muscle relaxation on sexual dysfunction in women with multiple sclerosis in Rafsanjan, 2023
Public title
Investigation the effect of progressive muscle relaxation on sexual dysfunction in women with multiple sclerosis in Rafsanjan, 2023
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-45
Obtaining a score less than 28 from the FSFI questionnaire
More than six months have passed since the diagnosis of the disease
Married and having intermittent sex with her husband' and not intending to divorce
Ability to perform daily personal tasks without assistance from others
Extended Disability Status Scale (EDSS) score less than equal to 4.5
Absence of pregnancy
No menopause
Not using sleeping pills, alcohol, drugs and drugs affecting sexual function
Not using common complementary treatments such as yoga, Pilates, meditation at the same time
Not using any kind of sexual drugs
Not having other chronic and acute physical and mental diseases according to the medical record
The husband's absence of known sexual disorders
Not being in the acute stage of the disease
Not having cognitive disorders
Exclusion criteria:
Unwillingness to cooperation
Having lethargy and weakness or reduced level of consciousness
being admitted to the hospital
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sampling will be purposeful and based on the study entry criteria, for this purpose, the eligible samples will be selected and divided into two groups based on the average score obtained from the FSFI questionnaire. Then, the allocation of samples in two intervention and control groups will be done by simple random drawing
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling is first purposeful and selected based on the criteria for entering the study, then based on the score obtained from the FSFI questionnaire, they are divided into two intervention and control groups, and finally they will be allocated to the two groups by a simple random method. The intervention group will receive progressive muscle relaxation training and no intervention will be performed on the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-05-14, 1402/02/24
Ethics committee reference number
IR.RUMS.REC.1402.022
Health conditions studied
1
Description of health condition studied
Sexual dysfunction in women with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Sexual performance score in the 19-question questionnaire of intimacy and sexual activity in multiple sclerosis (MSISQ19)
Timepoint
The measurement of the sexual function score will be before the intervention and 6 weeks after the intervention of muscle relaxation.
Method of measurement
The sexual performance score is measured using a 19-question questionnaire of multiple Sclerosis Intimacy and Sexuality
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Jacobson method of progressive muscle relaxation will be practiced every day for 20 minutes up to 6 weeks at home, at night before going to sleep. The subjects will be asked to wear comfortable clothes. Take out the watch, jewelry, etc. and lie down in a quiet and alone environment without noise or disturbing factors or sit on a chair with complete comfort and then do the sixteen muscle groups, starting from the hands, forearms, and arms. , shoulders, forehead, eyes and nose bridge, cheeks and jaw, mouth, neck, chest, waist or back, stomach, hips, thighs, legs, soleus muscle and finally the whole body, along with the tail Contract for 5 seconds (so that the client notices the contraction and stiffness of the muscle) and then expand and relax the muscles during exhalation for 10 seconds.
Category
Other
2
Description
Control group: no intervention will be done in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Diseases Department of Ali Ibn Abi Talib Hospital
Full name of responsible person
Shaghayegh Azarang rooy
Street address
Taleghani Blvd., Ayatollah Saidi Square, Hazrat Ali Ibn Abitalib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
aliebn_hospital@rums.ac.ir
Web page address
https://aliebn.rums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Sode Khanamani Falahatipur
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Web page address
https://rums.ac.ir/#anchor8
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse St., School of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
azarang98@gmail.com
Web page address
https://nm.rums.ac.ir/#anchor4
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse St., School of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
azarang98@gmail.com
Web page address
https://nm.rums.ac.ir/#anchor4
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse St., School of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
azarang98@gmail.com
Web page address
https://nm.rums.ac.ir/#anchor4
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