The Effect of Paula Method Exercises on Post-cesarean Section Distension

NCT05283707 | Unknown DMC

• 1 other identifier: Akd-3739
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. Method: The study was planned as a double-blind, randomized controlled experimental study. The study was carried out between November 2021 and February 2022 with women who had undergone cesarean section at Akdeniz University Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study. The number of individuals to be sampled from the population was determined by the G Power analysis and 80 women were included in the sample. The data of the study were collected using the Introductory Information Form, the Postoperative Follow-up Form, and the McGill Pain Scale Form. The women in the intervention group were given training on how to do the Paula Method Exercises in the postoperative period in line with the "Paula Method Exercises Training Plan" by the researcher. Conclusion: It is predicted that the findings obtained from the data of the study will guide nursing care practices and new researches for the relief of gas and distension after cesarean section.

Conditions

Cesarean Section Complications

Keywords

Distantion; Paula Method Exercises,; Flatulence; Abdominal Pain; Post Cesarean Care; Gas

Outcome Measures

Primary Outcomes (4)

• Number of bowel movements

  An increase in womens' number of bowel movements is a measure of outcome. This increase will be counted by listening with a stethoscope. For the first measurement, bowel sounds will be heard 2 times between 6-8 hours after cesarean section, before and after the intervention. For the second measurement, bowel sounds will be listened to 2 times in the morning on the post-op 1st day after cesarean section, before and after the intervention. For the third measurement, bowel sounds will be listened to 2 times in the morning on the post-op 2nd day after cesarean section, before and after the intervention. Bowel sounds will be listened to 6 times in total. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will decrease the time to pass gas and defecation (in hours) and increase the bowel sounds (in numbers). Significance level is set at p\<0.05 in analyzes.

  Bowel sounds will be listened to 6 times. The first measurement will be done between 6-8 hours after cesarean section, the second measurement will be done in the morning on the post-op 1st day, and the third in the morning on the 2nd post-op day.

• Visual Analogue Scale

  Application of Paula Method Exercises in the postoperative period after cesarean section; It is predicted that the Visual Analogue Scale score will decrease in the evaluation of pain due to distention. The minimum value is 0, the maximum value is 10. A low score indicates the success of the attempt. Significance level is set at p\<0.05 in analyzes.

  Pain will be evaluated 6 times. The first measurement will be made between 6-8 hours after cesarean section, the second measurement will be made in the morning on the 1st postoperative day, and the third in the morning on the 2nd day after the operation.

• First gas extraction time

  Until the patient has his first gas; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p\<0.05.

  Until you take your first gas; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.

• First defecation extraction time

  Until the patient has his first defecation; The first measurement is between 6-8 hours, the second measurement is made on the 1st day after cesarean section, and the third measurement is made in the morning on the 2nd post-operative day. It is predicted that the application of Paula Method Exercises in the postoperative period after cesarean section will reduce the time of first flatulence. The level of significance in the analyzes was determined as p\<0.05.

  Until you take your first defecation; The first measurement will be made between 6-8 hours after cesarean section, the second will be made on the 1st post-operative day, and the third will be made on the 2nd day after the operation.

Study Arms (2)

Intervention Group

EXPERIMENTAL

* Continuation of standard post-cesarean section care in the clinic. * Implementation of Paula Method Exercises Training Plan 6-8 hours after cesarean section (Paula Method Exercises Practice Card PEUK, Paula Method Exercises Video, Paula Method Exercises Flipcard) * Paula Method Exercises; by the researcher, after cesarean section 0.day 6-8 hours, 1st day morning, 2nd day morning. * Paula Method Exercises; It was applied by the researcher to the patient on the 0th day 6-8 hours, the 1st day in the morning, and the 2nd day in the morning after the cesarean section. * 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds before and after Paula Method Exercises, application of "McGill Pain Scale Short Form", * Evaluation of first flatulence after cesarean section and first defecation

Behavioral: Paula Method Exercises

Control Group

NO INTERVENTION

* Continuation of standard post-cesarean section care in the clinic. * 6-8 hours on day 0, morning on day 1, morning on day 2 after cesarean section Evaluation and recording of bowel sounds, application of "McGill Pain Scale Short Form", * Evaluation of first flatulence after cesarean section and first degassing

Interventions

Paula Method Exercises BEHAVIORAL

The Paula Method Exercises were administered by the researcher for 6 to 8 hours, for 10 to 15 minutes on the post-op first day and post-op second day, to women who had a cesarean section.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-45, who are planned to have an elective Cesarean Section (CD) under spinal anesthesia,
• Admitted to the service within six hours after cesarean section,
• No chronic Charles Bonnet Syndrome (CBS) disease,
• No history of serious (ilostomy, cholastomy, irritable bowel syndrome, etc.) disease related to the gastrointestinal tract,
• Those who volunteered to participate in the study and whose consent was obtained,
• No complications developed during or after the surgery,
• Women who do not have intellectual disability or perception problems and do not have communication difficulties will be included in the study.
• In order not to affect the research results; If there are women in the intervention and control group in the same hospital room, the last woman who was hospitalized in the same room will be excluded from the study.

You may not qualify if:

• Enema made,
• Any complication developed and taken to the intensive care unit,
• Not complying with the application process,
• The state of consciousness is not clear / will not be able to participate in the applications,
• Women who cannot communicate for any reason (hearing/speech/hearing, etc.) will be excluded from the research.
• Discharged before two days after cesarean section

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Univercity

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

Location

Related Publications (5)

• Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Shveiky D, Paltiel O. Randomized trial of circular muscle versus pelvic floor training for stress urinary incontinence in women. J Womens Health (Larchmt). 2009 Mar;18(3):377-85. doi: 10.1089/jwh.2008.0950.

  PMID: 19281321 BACKGROUND

• Liebergall-Wischnitzer M, Paltiel O, Hochner Celnikier D, Lavy Y, Manor O, Woloski Wruble AC. Sexual function and quality of life of women with stress urinary incontinence: a randomized controlled trial comparing the Paula method (circular muscle exercises) to pelvic floor muscle training (PFMT) exercises. J Sex Med. 2012 Jun;9(6):1613-23. doi: 10.1111/j.1743-6109.2012.02721.x. Epub 2012 Apr 17.

  PMID: 22510279 BACKGROUND

• Liebergall-Wischnitzer M, Shvieky D, Lavy Y, Woloski Wruble A, Noble A, Vaknin A. Paula Method (Circular Muscle Exercise) for Urinary Incontinence Symptoms of Women with Multiple Sclerosis: A Pilot Study. J Altern Complement Med. 2020 Jul;26(7):652-653. doi: 10.1089/acm.2020.0069. Epub 2020 May 29. No abstract available.

  PMID: 32471333 BACKGROUND

• Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29.

  PMID: 33249611 BACKGROUND

• Liebergall-Wischnitzer M, Hochner-Celnikier D, Lavy Y, Manor O, Arbel R, Paltiel O. Paula method of circular muscle exercises for urinary stress incontinence--a clinical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Sep-Oct;16(5):345-51. doi: 10.1007/s00192-004-1261-6. Epub 2005 Jan 20.

  PMID: 15660184 BACKGROUND

MeSH Terms

Conditions

Flatulence; Abdominal Pain; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rabiye Demir Işık

  Akdeniz Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 17, 2022
• Study Start: November 1, 2021
• Primary Completion: January 28, 2022
• Study Completion: December 30, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

TU (1)