Determining the effect of self-care application on the quality of life of women with pelvic organ prolapse
Design
A randomized clinical trial, with a control group with parallel groups, on 64 patients. Without blinding, randomization will be done by random allocation software.
Settings and conduct
Place of conducting this study: Women's Clinic of Imam Reza Hospital (AS); Women's Clinic of Hazrat Qaim Hospital; Women's Clinic of Umm El Benin Hospital; Gynecology Clinic in Mashhad. It will be done on 64 women with pelvic organ prolapse. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having symptoms of pelvic organ prolapse; Physician confirmation by examination for prolapse ≤III according to POP-Q; Literate to read and write, have a smartphone or tablet under the Android system, the ability to use a smartphone. Exclusion criteria: suffering from any type of urinary incontinence with a moderate to high degree based on the ICIQ-UI SF questionnaire; celibacy; use of neuroleptics; use of antagonists; pregnancy; history of hip surgery in the past year; History of pelvic physiotherapy in the last year.
Intervention groups
Intervention group: women with pelvic organ prolapse ≤III according to POP-Q, who meet the criteria for entering the research and install, study and implement the self-care application in addition to routine care and recommendations، Control group: women with pelvic organ prolapse ≤III according to POP-Q, who met the criteria for entering the research and received education related to prolapse face-to-face and pamphlets.
Main outcome variables
Quality of Life; Knowledge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230923059497N1
Registration date:2023-12-02, 1402/09/11
Registration timing:registered_while_recruiting
Last update:2023-12-02, 1402/09/11
Update count:0
Registration date
2023-12-02, 1402/09/11
Registrant information
Name
Zohra Mosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3375 4017
Email address
mousaviz991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-27, 1402/09/06
Expected recruitment end date
2024-02-18, 1402/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care application compared to routine care on the quality of life of patients with pelvic organ prolapse.
Public title
The effect of using the application on the quality of life of women with pelvic organ prolapse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of pelvic organ prolapse
Physician confirmation by examination for prolapse less or equal to III according to POP-Q
Having a smartphone or tablet under the Android system
The ability to use a smartphone
Literate to read and write
Exclusion criteria:
Suffering from any type of urinary incontinence with a moderate to high degree based on the ICIQ-UI SF questionnaire
Use of neuroleptics
Use of antagonists
pregnancy
Celibacy
History of pelvic physiotherapy in the last year
History of pelvic surgery in the last year
Childbirth in the past year
Use of pessary
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
People will be randomly divided into intervention and control groups. In this study, permutation blocks method will be used to generate the sequence of random assignment of people to the studied groups. The sequence of random allocation of people will be done using Random Allocation Software and the block size of four. There are six blocks in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Shahid Doctor Khwarazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-06-30, 1402/04/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.070
Health conditions studied
1
Description of health condition studied
pelvic organ prolapse.
ICD-10 code
N81.81
ICD-10 code description
Perineocele
Primary outcomes
1
Description
The score obtained in the quality of life questionnaire for prolapse disorders
Timepoint
The beginning of the study (before the start of the intervention) and two months after its start
Method of measurement
Quality of life questionnaire for prolapse disorders
2
Description
Degree of prolapse
Timepoint
The beginning of the study (before the start of the intervention) and two months after its start
Method of measurement
POP-Q system
Secondary outcomes
1
Description
The score obtained in the prolapse knowledge questionnaire.
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the intervention
Method of measurement
Prolapse knowledge questionnaire.
2
Description
The score obtained in the incontinence questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the intervention
Method of measurement
Incontinence knowledge questionnaire
Intervention groups
1
Description
"Intervention group:" These people watch and practice pelvic floor muscle strengthening exercises with the application 30 minutes a day for 2 months and have access to the educational content in the application and the quality of life form related to pelvic organ prolapse. They will complete the research at the beginning and 2 months after receiving the application.
Category
Rehabilitation
2
Description
Control group: These women will receive face-to-face prolapse education and pamphlets and will complete the quality of life form related to pelvic organ prolapse at the beginning of the study and 2 months after receiving the pamphlet and face-to-face education. .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Zohra Mosavi
Street address
Imam Reza Hospital; Imam Reza Square; Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1377591766
Phone
+98 51 3842 6082
Email
mousaviz991@mums.ac.ir
2
Recruitment center
Name of recruitment center
Umm al-Binin Hospital
Full name of responsible person
Zohra Mosavi
Street address
At the corner of Ayatollah Behjat 16; Zarineh intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۴۴۶۶۳۵۹۵
Phone
+98 51 3223 1065
Email
oah.it@mums.ac.ir
Web page address
3
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Zohra Mosavi
Street address
At the beginning of Ahmad Abad Street, Dr. Ali Shariati Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
https://quaem.mums.ac.ir
4
Recruitment center
Name of recruitment center
Gynecology clinic
Full name of responsible person
Zohra Mosavi
Street address
Nesl Omid clinic, second floor, Pasteur 5; Pasteur; Ahmedabad,
City
Mashhad
Province
Razavi Khorasan
Postal code
1377591766
Phone
+98 51 3846 7145
Fax
+98 51 3847 4012
Email
nasle.omid96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor; Qureshi Building; next to Hoizeh Cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology of Mashhad University of Medical Sciences and Health Services
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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hadizadeh talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Doctor Khwarazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
HadizadehZ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hadizadeh talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Doctor Khwarazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
3-38591511 051
Fax
Email
HadizadehZ@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohra Mosavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Doctor Khwarazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
: 9137913199
Phone
0098513754017
Email
mousaviz991@mums.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