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

NCT ID: NCT05283707

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention Group

* 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

Group Type EXPERIMENTAL

Paula Method Exercises

Intervention Type 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.

Control Group

* 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paula Method Exercises

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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Rabiye DEMIR ISIK

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabiye Demir Işık

Role: PRINCIPAL_INVESTIGATOR

Akdeniz Univercity

Locations

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Akdeniz Univercity

Antalya, Konyaaltı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19281321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22510279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32471333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33249611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15660184 (View on PubMed)

Other Identifiers

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Akd-3739

Identifier Type: -

Identifier Source: org_study_id

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