Protocol summary
-
Study aim
-
The effects of Pelvic floor rehabilitation in treatment of women with dyspareunia
-
Design
-
Two arm parallel group randomized controlled trial with blinded outcome assessment, sample size 64
-
Settings and conduct
-
Dyspareunia patients from Alzahra hospital and physiotherapy center who met the criteria were included in the study.
Treatment was done by one of the researchers and assessment was done by another one who was blinded to group allocation.
-
Participants/Inclusion and exclusion criteria
-
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
-
Intervention groups
-
Intervention Group: Pelvic floor physiotherapy (n=32)
Control group: No treatment(n=32)
-
Main outcome variables
-
pain;
pelvic floor muscles and deep abdominals strength and endurance;
female sexual functional index (FSFI).
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2014070118311N1
Registration date:
2014-08-09, 1393/05/18
Registration timing:
prospective
Last update:
2019-04-25, 1398/02/05
Update count:
1
-
Registration date
-
2014-08-09, 1393/05/18
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for Research,Tabriz University Of Medical Sciences
-
Expected recruitment start date
-
2014-07-11, 1393/04/20
-
Expected recruitment end date
-
2016-09-20, 1395/06/30
-
Actual recruitment start date
-
2014-09-21, 1393/06/30
-
Actual recruitment end date
-
2016-09-20, 1395/06/30
-
Trial completion date
-
2016-09-20, 1395/06/30
-
Scientific title
-
The effect of pelvic floor physical therapy on sexual function and pelvic floor muscle strength and endurance in women complaining dyspareunia
-
Public title
-
The effect of pelvic floor physical therapy on dyspareunia
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Women with pain in the genital area before, during, or after vaginal intercourse, and pain was greater than 8 on a 10-cm visual analogue scale (VAS).
Exclusion criteria:
If the women had any history of other pathophysiological conditions, such as infections, tumors, major psychiatric illnesses, vaginismus, vestibulodynia, vulvar dermatological conditions, painful bladder syndrome or interstitial cystitis, endometriosis, pregnancy, surgery on pelvic organs, or any ongoing treatment for dyspareunia, they were excluded from the study.
-
Age
-
From 20 years old to 50 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
64
Actual sample size reached:
64
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
participants were randomly assigned to one of two groups using
a block randomization procedure . The allocation sequence was generated by random allocation software.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
Blinding only occurred for assessor and statistician. Because of the nature of the intervention and control, participants and physiotherapist couldn’t be blinded.
blinded assessor did the assessment procedure including questionnaires and examination.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2014-06-26, 1393/04/05
-
Ethics committee reference number
-
5/4/2979
Health conditions studied
1
-
Description of health condition studied
-
Dyspareunia
-
ICD-10 code
-
N94.1
-
ICD-10 code description
-
Dyspareunia
Primary outcomes
1
-
Description
-
dyspareunia
-
Timepoint
-
Before and after intervention
-
Method of measurement
-
VAS
2
-
Description
-
Female sexual function index (FSFI)
-
Timepoint
-
before and after intervention
-
Method of measurement
-
Questionnaire
Secondary outcomes
1
-
Description
-
PFM strength
-
Timepoint
-
before after intervention
-
Method of measurement
-
oxford scale- vaginal examination
2
-
Description
-
PFM endurance
-
Timepoint
-
before after intervention
-
Method of measurement
-
oxford scale- vaginal examination
Intervention groups
1
-
Description
-
Patients had 10 physiotherapy sessions for three months
-
Category
-
Rehabilitation
2
-
Description
-
Control group: no treatment ( waiting list)
-
Category
-
N/A
1
-
Sponsor
-
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is no further information
-
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
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Yes - There is 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
-
Title and more details about the data/document
-
study protocol- data set
-
When the data will become available and for how long
-
starting 6 months after publication
-
To whom data/document is available
-
only available for people working in academic institutions
-
Under which criteria data/document could be used
-
data analysis with referencing this study
-
From where data/document is obtainable
-
researcher email
ghaderimailbox@gmail.com
-
What processes are involved for a request to access data/document
-
sending an email
-
Comments
-