Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279455
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-12-28
Brief Title:
Pelvic Floor Muscle Exercise During Pregnancy
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Evaluation of the Effect of Pelvic Floor Muscle Exercise During Pregnancy on Sexual Function Lower Urinary Tract Symptoms and Birth Process
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function lower urinary tract symptoms and birth process The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital Power analysis was performed to determine the number of samples to be included in the study It was determined that 29 pregnant women should be included in each group experimental and control Considering the possibility of data loss 50 pregnant women were included in each group As a result of the exclusion of 8 women who withdrew from participating in the study 5 women due to risky pregnancies bleeding preeclampsia and gestational diabetes and 17 women due to cesarean delivery the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained Pregnant women in the experimental group were gestational aged 18-20 Two sessions of training were given on female reproductive and urinary system anatomy physiological changes during pregnancy and their effects on sexual life and pelvic floor muscle exercises using the Pelvic Floor Health Sexual Life Training Booklet during Pregnancy and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy Pregnant women were asked to perform pelvic floor muscle exercises 3 sets a day 3 days a week for 12 weeks starting from the 20th week of pregnancy and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic Pregnant women who apply to the outpatient clinic are examined by nurses with their vital signs taken and anamnesis taken by the physician Recommendations are made regarding the complaints of pregnant women Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above
Detailed Description:
Purpose of the research This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function lower urinary tract symptoms and birth process
Type of Research This research is of randomized controlled prospective type
Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital Department of Gynecology and Obstetrics between December 2022 and October 2023
Population and Sample of the Research The population of the research consisted of pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital Department of Gynecology and Obstetrics GPower 3197 Program was used to determine the sample number of pelvic floor muscle exercise experimental group and control groups The Female Sexual Function Index was taken as the main parameter in the study As a result of the power analysis performed with α005 and power of 95 effect size 07 the sample was calculated as 29 pregnant women for each group Considering that there may be losses during the study period it was decided to include a total of 100 pregnant women between the ages of 18-40 including the experimental group n 50 and the control group n 50
The numbers to be included in the sample were determined using the randomization program wwwrandomizerorg
As a result of the exclusion of 8 women who withdrew from participating in the study 5 women due to risky pregnancies bleeding preeclampsia and gestational diabetes and 17 women due to cesarean delivery the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained
Research data were collected with Personal Information Form between 18-20th week of pregnancy Female Sexual Function Index between 18-20th week of pregnancy and 32nd week of pregnancy Mid-term Evaluation Form 26th week of pregnancy International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form ICIQ-FLUTS LF between 18-20th week of pregnancy and 32nd week of pregnancy Birth Process Follow-up Form between 3-7th days after birth and Pelvic Floor Muscle Exercise Follow-up Form 20-32 between weeks of pregnancy
Type of Research This research is of randomized controlled prospective type
Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital Department of Gynecology and Obstetrics between December 2022 and October 2023
Population and Sample of the Research The population of the research consisted of pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital Department of Gynecology and Obstetrics GPower 3197 Program was used to determine the sample number of pelvic floor muscle exercise experimental group and control groups The Female Sexual Function Index was taken as the main parameter in the study As a result of the power analysis performed with α005 and power of 95 effect size 07 the sample was calculated as 29 pregnant women for each group Considering that there may be losses during the study period it was decided to include a total of 100 pregnant women between the ages of 18-40 including the experimental group n 50 and the control group n 50
The numbers to be included in the sample were determined using the randomization program wwwrandomizerorg
As a result of the exclusion of 8 women who withdrew from participating in the study 5 women due to risky pregnancies bleeding preeclampsia and gestational diabetes and 17 women due to cesarean delivery the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained
Research data were collected with Personal Information Form between 18-20th week of pregnancy Female Sexual Function Index between 18-20th week of pregnancy and 32nd week of pregnancy Mid-term Evaluation Form 26th week of pregnancy International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form ICIQ-FLUTS LF between 18-20th week of pregnancy and 32nd week of pregnancy Birth Process Follow-up Form between 3-7th days after birth and Pelvic Floor Muscle Exercise Follow-up Form 20-32 between weeks of pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None