The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality

NCT ID: NCT05945095

Last Updated: 2023-07-14

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-05-20

Brief Summary

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The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday.

Pain levels of mothers in both groups will be evaluated every two hours after delivery.

In addition, the amount of analgesic use will be compared and comments will be made on the level of pain. The sleep quality of the postpartum women will be questioned the day after the cesarean section.

Detailed Description

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The study will be conducted on mothers who had planned cesarean section. The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups.

Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.

In the data collection process of the research, the "personal information form" consisting of 24 questions and developed by the researchers as a result of the literature review, the "Richard-Campbell Sleep Scale" and the "Visual Comparison Scale (VAS)" will be used.

Prenatal interviews will be conducted with the pregnant women and their status of meeting the following inclusion criteria will be evaluated, and all pregnant women who comply with the criteria and agree to participate in the study will be asked questions regarding the prenatal period in the personal information form.

After the birth, the information about the surgery in the personal information form will be completed.

Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.

The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday. Pain levels of mothers in both groups will be evaluated every two hours after delivery.

In addition, the amount of analgesic use will be compared and comments will be made on the level of pain.

The sleep quality of the postpartum women will be questioned the day after the cesarean section.

Gastrointestinal system functions will be followed in the postoperative period and will be evaluated by asking questions about gas output and defecation time in the personal information form.

After the mothers in both groups have defecated, the data collection process will be completed from the mother concerned.

The data obtained will be entered into the SPSS (Statistical Package for the Social Sciences) 22.0 package program and evaluated with appropriate statistical analysis.

Inclusion Criteria for Research:

be 18 years or older, having a planned cesarean section, to receive general anesthesia during surgery, chronic constipation and no history of diarrhea be at least a primary school graduate, and is not a communication problem.

Conditions

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Mothers Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups.

Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

Gum chewing group

Group Type EXPERIMENTAL

Gum chewing group

Intervention Type OTHER

The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.

Control group

Routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gum chewing group

The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be eighteen years of age or older,
* Having a planned cesarean section,
* To receive general anesthesia in the surgery,
* No history of chronic constipation and diarrhea,
* At least primary school graduate
* Communication is not a problem.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Artvin Coruh University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Kaloglu Binici

Principal Investigator (PhD Research Nurse)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek KALOĞLU BİNİCİ, PhD

Role: PRINCIPAL_INVESTIGATOR

Artvin Coruh University

Locations

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Artvin State Hospital

Artvin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dilek KALOĞLU BİNİCİ, PhD

Role: CONTACT

5058110022

Enes BULUT

Role: CONTACT

5464213863

Facility Contacts

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Dilek KALOĞLU BİNİCİ, PhD

Role: primary

5058110022

Enes BULUT, PhD

Role: backup

5464213863

References

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Pereira Gomes Morais E, Riera R, Porfirio GJ, Macedo CR, Sarmento Vasconcelos V, de Souza Pedrosa A, Torloni MR. Chewing gum for enhancing early recovery of bowel function after caesarean section. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD011562. doi: 10.1002/14651858.CD011562.pub2.

Reference Type RESULT
PMID: 27747876 (View on PubMed)

Other Identifiers

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Gum after cesarean section

Identifier Type: -

Identifier Source: org_study_id

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