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Completed

NCT Number: NCT05343520

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

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.

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Key information

Conditions

Genito-Pelvic Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Exercise Pregnancy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gulcin Bozkurt

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Pelvic floor muscle exercises

Behavioral

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 outcomes

  1. 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.

    Time frame: Only 30th week of gestation

    Pelvic Floor Muscle Exercises effect measured with Descriptive Form

  2. 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.

    Time frame: 30th week of gestation

    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

  3. 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.

    Time frame: 6th postpartum week

    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

  4. 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.

    Time frame: 30th week of gestation

    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.

  5. 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.

    Time frame: 6th postpartum week

    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.

  6. 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.

    Time frame: Postpartum 72 nd hour

    Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.

  7. 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.

    Time frame: 6th postpartum week

    Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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