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

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ClinicalTrials.gov Identifier: NCT05945095
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Dilek Kaloglu Binici, Artvin Coruh University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mothers Cesarean Section Complications Other: Gum chewing group Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
Actual Study Start Date : March 27, 2023
Estimated Primary Completion Date : December 27, 2023
Estimated Study Completion Date : May 20, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
Gum chewing group
 Other: 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.
No Intervention: Control group
Routine care


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: "change" is being assessed. up to 10-12 hours after cesarean section ]
    VAS is used to measure perceived pain. VAS is a 10cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The mother is asked to mark their current pain level on the line


Secondary Outcome Measures :
  1. Richard-Campbell Sleep Scale (RCUI) [ Time Frame: in the morning the day after the cesarean section ]

    The Turkish validity and reliability study of the scale, which was developed by Richards in 1987, was carried out by Özlü and Özer in 2015.

    Each item of the six-item scale, which evaluates the depth of night sleep, the duration of falling asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment, is evaluated on a chart between 0-100 using the visual analog scale technique.

    A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep.

    The total score of the scale is evaluated over 5 items, and the sixth item, which evaluates the noise level in the environment, is excluded from the total score evaluation.

    As the score of the scale increases, the sleep quality of the patients also increases.

    The Cronbach's alpha value of the scale is 0.91.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • Exclusion Criteria:
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945095


Contacts
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Contact: Dilek KALOĞLU BİNİCİ, PhD 5058110022 dkaloglu@artvin.edu.tr
Contact: Enes BULUT 5464213863 bulutts61@artvin.edu.tr

Locations
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Turkey
Artvin State Hospital Recruiting
Artvin, Turkey, 08000
Contact: Dilek KALOĞLU BİNİCİ, PhD    5058110022    dkaloglu@artvin.edu.tr   
Contact: Enes BULUT, PhD    5464213863    bulutts61@artvin.edu.tr   
Principal Investigator: Hava ÖZKAN         
Sponsors and Collaborators
Artvin Coruh University
Investigators
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Principal Investigator: Dilek KALOĞLU BİNİCİ, PhD Artvin Coruh University
More Information
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Publications of Results:

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Responsible Party: Dilek Kaloglu Binici, Principal Investigator (PhD Research Nurse), Artvin Coruh University
ClinicalTrials.gov Identifier: NCT05945095    
Other Study ID Numbers: Gum after cesarean section
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilek Kaloglu Binici, Artvin Coruh University:
General anesthesia,
Sleep Quality
Chewing Gum, Pain,
Cesarean section,