Clinical trial NCT05283707: The Effect of Paula Method Exercises on Post-cesarean Section Distension
Official title: The Effect of "Paula Method Exercises" on the Prevention of Postoperative Distention and Pain Due to Distention After Cesarean Section: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Distantion
Paula Method Exercises,
Flatulence
Abdominal Pain
Post Cesarean Care
Gas
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Aim:To examine the effect of "Paula Method Exercises" after cesarean section on the prevention of postoperative distention and pain due to distension. The gastrointestinal system problems experienced by all individuals undergoing abdominal surgery are important as they affect both the mother and the baby during the post-cesarean section period.

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. Equal numbers of 80 women who agreed to participate in the study were assigned to the intervention and control groups (https://www.random.org) using the simple randomization method using a simple random numbers table. Women in the intervention and control groups received standard postoperative care in the clinic after cesarean section. In addition, 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, and the "Paula Method Exercises Card" and "Paula Method Exercises Practice Video" were used, which facilitated the practice of the exercises. Paula Method Exercises were applied to the women in the intervention group by the researcher for 10-15 minutes on postoperative day 0, day 1 and day 2. The data of the study were collected with the "Descriptive Information Form", "Postoperative Follow-up Form" and "McGill Pain Scale Short Form". To both research groups; "Postoperative Follow-up Form" and "McGill Pain Scale Short Form" were applied between 6th and 8th hours, 1st and 2nd days after cesarean section. After the data are collected, the women in the control group will be given Paula Method Exercises training before discharge.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of bowel movements
timeFrame: 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.
measure: Visual Analogue Scale
timeFrame: 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.
measure: First gas extraction time
timeFrame: 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.
measure: First defecation extraction time
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz Univercity
state: Konyaaltı
Study officials:
affiliation: Akdeniz Univercity
name: Rabiye Demir Işık
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.