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

Primary Purpose

Cesarean Section Complications

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Paula Method Exercises
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section Complications focused on measuring Distantion, Paula Method Exercises,, Flatulence, Abdominal Pain, Post Cesarean Care, Gas

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz Univercity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2022
Last Updated
March 8, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05283707
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Distantion, Paula Method Exercises,, Flatulence, Abdominal Pain, Post Cesarean Care, Gas

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Paula Method Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of bowel movements
Description
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.
Time Frame
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.
Title
Visual Analogue Scale
Description
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.
Time Frame
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.
Title
First gas extraction time
Description
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.
Time Frame
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.
Title
First defecation extraction time
Description
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.
Time Frame
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiye Demir Işık
Organizational Affiliation
Akdeniz Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz Univercity
City
Antalya
State/Province
Konyaaltı
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19281321
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.
Results Reference
background
PubMed Identifier
22510279
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.
Results Reference
background
PubMed Identifier
32471333
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.
Results Reference
background
PubMed Identifier
33249611
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. Erratum In: J Adv Nurs. 2021 Nov;77(11):4598.
Results Reference
background
PubMed Identifier
15660184
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.
Results Reference
background

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

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