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Comparision of the effectiveness of biofeedback and pelvic floor exercises on the improving chronic pelvic pain and quality of sexual life in women with endometriosis

Protocol summary

Study aim
Comparing the effectiveness of biofeedback and pelvic floor exercises on improving chronic pelvic pain and quality of sexual life in women with endometriosis
Design
RCT, parallel groups, Bilaterally blind,randomized, phase 2 on 96 patients, random numbers table is used for randomization
Settings and conduct
This RCT is Bilaterally blind,at the participant and data analyst level, which will be conducted on 96 women with endometriosis visiting women's clinics affiliated to SUMS. The participants will be randomly divided into 3 groups of 32 people. group A (control), only routine care, group B (intervention), in addition to routine care of pelvic floor exercises, and group C (intervention), in addition to routine care, will receive biofeedback, the relevant questionnaires including demographic characteristics, visual scale Pain and quality of sexual life of Simond women in 2005 before and 8 weeks after the intervention will be provided to the participants and the obtained data will be analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married, age between 18 and 45 years old, having minimum literacy and... Exclusion criteria: severe endometriosis, use of hormonal drugs, indication for surgery, suffering from spine diseases, discopathy, cardiovascular failure and pulmonary, myopathy, cancer and...
Intervention groups
Participants are randomly assigned to 3 groups, group A, will receive only routine care to relieve chronic pelvic pain, and group B will receive pelvic floor exercise program according to the protocol to relieve chronic pelvic pain in addition to routine care.will receive In group C , in addition to routine care to relieve chronic pelvic pain, in order to properly learn Kegel exercise,10 biofeedback sessions for 30 minutes will receive
Main outcome variables
Measurement of chronic pelvic pain and quality of sexual life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240619062179N1
Registration date: 2024-07-07, 1403/04/17
Registration timing: prospective

Last update: 2024-07-07, 1403/04/17
Update count: 0
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
Masumeh Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7169
Email address
masome.ghasemian.1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effectiveness of biofeedback and pelvic floor exercises on the improving chronic pelvic pain and quality of sexual life in women with endometriosis
Public title
Effectiveness Of Biofeedback And Pelvic Floor Exercises With Endometriosis Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being married Having minimal reading and writing literacy Suffering from mild to moderate endometriosis Suffering from chronic pelvic pain for at least 3 months Reluctance to take hormone medication or contraindications to hormone therapy Aged between 18 and 45 years Surgery not indicated Suffering from spine diseases, discopathy, heart-disease and pulmonary failure, myopathy, cancer Increased intracranial pressure Not history of pelvic surgeries body mass index less than 30
Exclusion criteria:
The unwillingness of the participants to continue the interventions The occurrence of certain diseases or hip fractures after the start of the intervention (people who suffer during the interventions) Not complete more than 10% of the questionnaire Not participate in biofeedback sessions (at least 5 sessions) Not doing home exercises
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to three treatment groups (A, B, C), the permutation block method without placement will be used. 6 egg balls of the same color are prepared and the letter A is placed on two balls, the letter B is placed on two balls, and the other two balls are placed The letter C will be written and we pour it into a cloudy and non-transparent bag and stir it. Without looking at the bag, the researcher takes out one of the balls from the bag and puts it aside, and then takes out the other balls from the bag in the same way, we will repeat this 16 times until 96 people enter the study. become.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done at the level of the participants and the data analyst. For this purpose, a code will be assigned to each participant, and the participants and the data analyst will not know which of the intervention and control groups each participant is in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of Nursing and Midwifery Faculties,Management and Medical Information
Street address
Faculty of Nursing and Midwifery,Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.028

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified

Primary outcomes

1

Description
Chronic pelvic pain
Timepoint
Before the start of the intervention and 8 weeks after the start of the intervention
Method of measurement
Visual Analogue Scale

2

Description
quality of sexual life
Timepoint
Before the start of the intervention and 8 weeks after the start of the intervention
Method of measurement
Questionnaire of the sexual life quality of women, Simond et al., 2005

Secondary outcomes

empty

Intervention groups

1

Description
Control group: (Group A) will receive only routine care(NSAID if needed) to relieve chronic pelvic pain.
Category
Treatment - Other

2

Description
InterventionIn group (B): addition to routine care, will receive the pelvic floor exercise program according to the protocol. Five exercises to strengthen and restrain the pelvic floor muscles, selected from the National Health Service protocol, along with Kegel exercises in the form of 150 isometric contractions (5 cycles of 30, which is to hold the contractions in the first three cycles for one second, the fourth cycle for five seconds and the fifth cycle for thirty seconds), it should be noted that Kegel exercises are started in the lying position, until the patients are able to do it in To acquire sitting and standing.This protocol will be taught to the patients by the researcher and they will perform pelvic exercises for 8 sessions (once a week) under the supervision of the researcher, as well as perform pelvic exercises in the intervals of the sessions, for 8 consecutive weeks daily at home, recommendation becomes In addition, in the first training session of pelvic floor exercises, each of the participants will be given a training book for pelvic exercises to perform home exercises.
Category
Treatment - Other

3

Description
Intervention group: (group C) in addition to routine care to relieve chronic pelvic pain, in order to properly learn Kegel exercises (contraction of pelvic floor muscles), 10 biofeedback sessions (first two weeks, twice a week and then once a week) for 30 minutes, they will receive. The vaginal probe (ground electrode) of the Farmed biofeedback device will be placed on the ASIS bone and no additional surface electrode will be used, it will be placed in the lithotomy position for the patients, and after inserting the probe, they will be asked to be in the lateral decubitus position and during biofeedback, perform Kegel exercises according to the protocol taught to them in the form of 150 isometric contractions (5 cycles of 30).Also, patients are asked to do Kegel exercises daily at home for 8 consecutive weeks in between biofeedback sessions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Zahra Rastegari
Street address
Namazi,Square,Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Zahra Rastegari
Street address
Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
info@sums.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Zahra Rastegari
Street address
next to Faculty Medical,Karimkhan Zand Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1099
Email
FaghihiHsp@sums.ac.ir

4

Recruitment center
Name of recruitment center
Haxrat Zainab Hospital
Full name of responsible person
Zahra Rastegari
Street address
Haxrat Zainab Hospital,Defa Moghadas intersection,Shiraz
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6811
Email
Zeinabhp@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seyed Vahid Hosseini
Street address
In front of Fars Regional Electric Company,next to Hazrat Fatemeh Al-Zahra Mosque,Karimkhan Zand Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rastegari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh(PBUH),entrance of Namazi Hospital,Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
rastegari.zahra2015@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rastegari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh(PBUH),entrance of Namazi Hospital,Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
rastegari.zahra2015@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Ghasemian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh(PBUH),entrance of Namazi Hospital,Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
masome.ghasemian.1998@gmail.com

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
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