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

NCT05343520 | Completed

• 1 other identifier: 13022260-300-76447
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Genito-Pelvic Pain; Pelvic Floor Muscle Exercise; Pregnancy

Keywords

Pain; Exercise; Pregnancy; Genito-Pelvic; Postpartum

Outcome Measures

Primary Outcomes (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.

  Pelvic Floor Muscle Exercises effect measured with Descriptive Form

  Only 30th week of gestation

• 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

  30th week of gestation

• 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

  6th postpartum week

• 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.

  30th week of gestation

• 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.

  6th postpartum week

• 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.

  Postpartum 72 nd hour

• 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.

  6th postpartum week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Pelvic floor muscle exercises

Control Group

NO INTERVENTION

The control group were filled only data collection forms

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Gulcin Bozkurt

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 20445961 BACKGROUND

• 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.

  PMID: 19170851 BACKGROUND

• 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.

  PMID: 10955426 BACKGROUND

• 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.

  PMID: 20446346 BACKGROUND

• 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.

  PMID: 18818022 BACKGROUND

• 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.

  PMID: 18307483 BACKGROUND

• 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.

  PMID: 27872022 BACKGROUND

• 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.

  PMID: 12028982 BACKGROUND

• 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.

  PMID: 27921161 BACKGROUND

• 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.

  PMID: 35678835 DERIVED

MeSH Terms

Conditions

Pain; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Husniye DINC KAYA, assoc.prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: December 30, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

TU (1)