comparison between effects of face-to-face and online pelvic physiotherapy for vaginismus treatment in pain reduction and sexual function of women with vaginismus
Design
Parallel randomized controlled clinical trail
Settings and conduct
This study will take place in the pelvic floor physiotherapy center of the university.
The third researcher as assessor will be expert in pelvic floor physiotherapy and will not be informed about the treatment groups.
Participants/Inclusion and exclusion criteria
inclusion criteria: Participants will be entered into the intervention group (in-person treatment) and control group (online treatment) based on DSM-5 criteria. Participants will be in the age of 20-40 years with severity of vaginismus 3 or 4 according to the Lamont classification. exclusion criteria: secondary vaginismus, non-cooperation to continue the treatment process and follow-up evaluation, untreated vaginal infection, wound in the perineum, anal wound, neuromuscular diseases such as myasthenia gravis, vulvodynia, urinary tract problems.
Intervention groups
1- The intervention group including face-to-face pelvic floor physiotherapy
2- The control group including online treatment
In both groups, interventions will be carried out for 4 weeks by a pelvic floor physiotherapist.
Main outcome variables
successful intercourse report by the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140811018760N8
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of in person pelvic floor physiotherapy for vaginismus with not in person online treatment: A randomized clinical trail
Public title
The comparison of in person pelvic floor physiotherapy for vaginismus with not in person online treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The study subjects are women suffering from vaginismus who will refer to the mentioned centers in 2023-2024. Based on DSM-5 criteria, the participants will enter the intervention group (in-person treatment) and the control group (not in-person treatment). Participants will be 20-40 years with severity of vaginismus 3 or 4 according to the Lamont classification (5-8).
Exclusion criteria:
Secondary vaginismus, lack of cooperation to continue treatment and follow-up evaluation, untreated vaginal infection, perineal ulcer, anal ulcer, neuromuscular diseases such as myasthenia gravis, vulvodynia, urinary tract problems.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random block method with block sizes of 4 and 6 and with allocation ratio of 1:1 will be allocated to two groups. For Allocation Concealment, the type of intervention received will be written on a piece of paper and placed inside sealed envelopes numbered consecutively. The envelopes will be opened in the order in which the participants enter the study and the type of group of people will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study cannot be blinded due to the type of interventions regarding the patient and the therapist, so it will be one-sided blind and the assessor will be blinded to the treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
school of rehabilitation, Daneshgah Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.110
Health conditions studied
1
Description of health condition studied
vaginismus
ICD-10 code
N94.2
ICD-10 code description
Vaginismus
Primary outcomes
1
Description
successful and painless penetration report
Timepoint
At the beginning(before the start of intervention) and 14 days and 6 months after the start of the intervention
Method of measurement
patient report
Secondary outcomes
1
Description
vaginismus severity
Timepoint
at the beginning (before the start of intervention) and 14 days and 6 months after beginning of the intervention
Method of measurement
Lamont scale
2
Description
pain intensity
Timepoint
at the beginning (before the start of intervention) and 14 days and 6 months after beginning of the intervention
Method of measurement
numerical pain score (NPS)
3
Description
sexual function
Timepoint
at the beginning (before the start of intervention) and 14 days and 6 months after beginning of the intervention
Method of measurement
female sexual function index
Intervention groups
1
Description
Intervention group: In both the intervention and control groups, participants will be taught a simple and understandable form of pelvic floor anatomy. perineal massage, breathing techniques and pelvic floor muscle relaxation training, use of silicone dilators or self-made tools (using cotton swab, cotton and latex cover like condom) will be done by the pelvic floor physiotherapist in the clinic . In the intervention group, specific techniques will be used to insert silicone dilators by the participants, under direct supervision of the therapist. content of the training will be same in both groups. Face-to-face treatment sessions will be 4 sessions in two weeks. duration of sessions will depend on the therapist's diagnosis and the patient's needs. In both groups, successful penetration will be considered as treatment, and pain and sexual function of both groups will be evaluated before and after the intervention. Follow-up will be conducted 6 weeks after The last treatment session by a telephone interview to examine pain intensity and sexual function in both groups.
Category
Rehabilitation
2
Description
Control group: In both intervention and control groups, people will be taught a simple and understandable form of pelvic floor anatomy. perineal massage, breathing techniques and pelvic floor muscle relaxation training, use of silicone dilators or self-made tools (using cotton swab, cotton and latex cover like condom) will be done by the patient at home. In the control group, the treatment will be online and in a single session. During an online visit session, the anatomy of the pelvic floor is first taught, and then we ask the participant to perform all the mentioned techniques after making dilators. Every three days, she will be asked about her progress and if needed, guidance for continuation of the treatment will be provided. The content of the training will be the same in both groups. online treatment will also be done using video calls from available and possible platforms for the therapist (Skype, WhatsApp, etc.) 4 sessions in two weeks. duration of sessions will depend on the therapists diagnosis and patients need. In both groups, successful penetration will be considered as treatment, and pain and sexual function of both groups will be evaluated before and after the intervention. Follow-up will be conducted 6 weeks after The last treatment session by a telephone interview to examine pain intensity and sexual function in both groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical sciences, Faculty of rehabilitation
Full name of responsible person
Fariba Ghaderi
Street address
Faculty of rehabilitation, Daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Email
ghaderimailbox@gmail.com
2
Recruitment center
Name of recruitment center
Pelvic floor physiotherapy clinic - Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Street address
Pelvic floor physiotherapy clinic - Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 41 3329 9799
Email
ghaderif@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Faculty of rehabilitation, daneshgah Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3337 5359
Email
ghaderimailbox@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
Professor- PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Email
ghaderif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
Professor- PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Email
ghaderif@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
Professor- PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Email
ghaderif@tbzmed.ac.ir
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