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The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period

Primary Purpose

Genito-Pelvic Pain, Pelvic Floor Muscle Exercise, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic floor muscle exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Genito-Pelvic Pain focused on measuring Pain, Exercise, Pregnancy, Genito-Pelvic, Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria for the study:

  • Pregnant patients who want to join the study,
  • Are primipara, not diagnosed with risky pregnancy,
  • Are 30 weeks of gestation,
  • Have no genito-pelvic pain pre-pregnancy,
  • Have no vulvar varicosities,
  • Are over the age of 18 and have no communication barrier (speaking Turkish)

Exclusion Criteria:

-

Sites / Locations

  • Gulcin Bozkurt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

30 pregnant women in the experimental group, pelvic floor muscle exercise was explained in detail and an exercise brochure was given in addition. Pelvic floor muscle exercises were taught by the researcher G.Y. In order for the exercise to be continued or applied correctly, the experimental group was interviewed by phone every 2 weeks. Information was given about continuing pelvic floor muscle exercises beginning from the 30th week of pregnancy until the postpartum 6th week.

The control group were filled only data collection forms

Outcomes

Primary Outcome Measures

When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Muscle Exercises effect measured with Descriptive Form
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
April 20, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05343520
Brief Title
The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period
Official Title
The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Abstract Introduction and hypothesis The goal of the study is figuring out the effect of pelvic floor muscle exercises on genito-pelvic pain levels during the postpartum period. Methods The data of the study, which was carried out in a randomized controlled experimental design, were collected in the antenatal policlinic of a public hospital between June-December 2019. There were 60 pregnant women in the experimental and control groups. Pelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th week of gestation to the 6th postpartum week. The control group was not given pelvic floor muscle exercises training and only data collection forms were filled. During the study, the Descriptive Form, Verbal Category Scale, Pelvic Floor Distress Inventory-20, and Labour and Postpartum Information Form were applied to the pregnant women in both groups.
Detailed Description
Introduction Some important changes are observed on the pelvic floor musculature during the pregnancy and labour. Stretching occurs in nerve, muscle, fascia and ligament structures in the pelvic floor. This affects the pelvic floor musculature, causing dysfunction and pelvic pain. As a result of the study by Paterson et al. (2009), women stated that genito-pelvic pain started during pregnancy. Women reported that genito-pelvic pain was localized only on both sides of the genital area during pregnancy, and the pain was only in the genital area in the first days of the postpartum period. It is estimated that genito-pelvic pain occurs in approximately 22% of pregnancy [3]. Acute genito-pelvic postpartum pain is a common problem regardless of vaginal delivery or caesarean section. Acute postpartum genito-pelvic pain rates can be up to 85%. This rate is observed as 92% one day after caesarean and vaginal delivery. Postpartum pain due to acute injuries from birth usually gets better in the first 2-3 months. However, for some new mothers, acute genito-pelvic pain may persist longer after delivery. Considering that there are over 100 million births per year worldwide, the risk of women experiencing genito-pelvic pain increases accordingly. According to these estimations, at least one million women worldwide may suffer from persistent postpartum genito-pelvic pain for one year or more after giving birth. Acute genito-pelvic pain, on the other hand, negatively affects the recovery of the perineal region in the postpartum period, problems in bladder and bowel functions, and activities of daily living. Pelvic floor muscle exercises strengthen the pelvic floor muscles and increase urethral sphincter pressure. Strengthened pelvic floor muscles provide cushioning support to the pelvic organs and prevent pelvic organ prolapse and urinary incontinence by increasing urethral sphincter pressure (and promoting urethral muscle hypertrophy). They are also involved in sexual function and continence. Pelvic floor muscle exercises are exercises that provide the strength, endurance, contraction, relaxation or development of the pelvic floor muscles. In line with this literature, this study was conducted to determine the effect of pelvic floor muscle exercises applied during pregnancy on the level of genito-pelvic pain after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genito-Pelvic Pain, Pelvic Floor Muscle Exercise, Pregnancy
Keywords
Pain, Exercise, Pregnancy, Genito-Pelvic, Postpartum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The pregnant women who met the sampling criteria were assigned to the experimental or control groups with the numbers given by the generator on the website www.random.org. Odd numbers represented the experimental group, while even numbers represented the control group. In order to prevent the interaction of the pregnant women in the experimental and control groups with each other, a special examination room was arranged in the Antenatal Polyclinic and the study was carried out there. Pelvic floor muscle exercise was taught by the researcher (GY). Since the researcher knew which group the pregnant women in the sample were in, the study was single-blind. However, statistical analysis is double-blind because the statistics of the data are made by a different person.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
30 pregnant women in the experimental group, pelvic floor muscle exercise was explained in detail and an exercise brochure was given in addition. Pelvic floor muscle exercises were taught by the researcher G.Y. In order for the exercise to be continued or applied correctly, the experimental group was interviewed by phone every 2 weeks. Information was given about continuing pelvic floor muscle exercises beginning from the 30th week of pregnancy until the postpartum 6th week.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group were filled only data collection forms
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle exercises
Intervention Description
Pelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th gestational week to the 6th postpartum week.
Primary Outcome Measure Information:
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Pelvic Floor Muscle Exercises effect measured with Descriptive Form
Time Frame
Only 30th week of gestation
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
Time Frame
30th week of gestation
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
Time Frame
6th postpartum week
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Time Frame
30th week of gestation
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Time Frame
6th postpartum week
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
Time Frame
Postpartum 72 nd hour
Title
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Description
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
Time Frame
6th postpartum week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant Women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for the study: Pregnant patients who want to join the study, Are primipara, not diagnosed with risky pregnancy, Are 30 weeks of gestation, Have no genito-pelvic pain pre-pregnancy, Have no vulvar varicosities, Are over the age of 18 and have no communication barrier (speaking Turkish) Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husniye DINC KAYA, assoc.prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Gulcin Bozkurt
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20445961
Citation
Bortolini MA, Drutz HP, Lovatsis D, Alarab M. Vaginal delivery and pelvic floor dysfunction: current evidence and implications for future research. Int Urogynecol J. 2010 Aug;21(8):1025-30. doi: 10.1007/s00192-010-1146-9. Epub 2010 May 6.
Results Reference
background
PubMed Identifier
19170851
Citation
Paterson LQ, Davis SN, Khalife S, Amsel R, Binik YM. Persistent genital and pelvic pain after childbirth. J Sex Med. 2009 Jan;6(1):215-21. doi: 10.1111/j.1743-6109.2008.01063.x.
Results Reference
background
PubMed Identifier
10955426
Citation
Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x.
Results Reference
background
PubMed Identifier
20446346
Citation
Vermelis JM, Wassen MM, Fiddelers AA, Nijhuis JG, Marcus MA. Prevalence and predictors of chronic pain after labor and delivery. Curr Opin Anaesthesiol. 2010 Jun;23(3):295-9. doi: 10.1097/aco.0b013e32833853e8.
Results Reference
background
PubMed Identifier
18818022
Citation
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Results Reference
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PubMed Identifier
18307483
Citation
Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
Results Reference
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PubMed Identifier
27872022
Citation
Rosen NO, Pukall C. Comparing the Prevalence, Risk Factors, and Repercussions of Postpartum Genito-Pelvic Pain and Dyspareunia. Sex Med Rev. 2016 Apr;4(2):126-135. doi: 10.1016/j.sxmr.2015.12.003. Epub 2016 Jan 11.
Results Reference
background
PubMed Identifier
12028982
Citation
Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002 May 25;324(7348):1258-62. doi: 10.1136/bmj.324.7348.1258. No abstract available.
Results Reference
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PubMed Identifier
27921161
Citation
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
Results Reference
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PubMed Identifier
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Citation
Yetiskin G, Dinc Kaya H. The effect of pelvic floor muscle exercises applied during pregnancy on genito-pelvic pain level in postpartum period. Int Urogynecol J. 2022 Oct;33(10):2791-2799. doi: 10.1007/s00192-022-05225-2. Epub 2022 Jun 9.
Results Reference
derived

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The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period

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