- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945095
The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dilek KALOĞLU BİNİCİ, PhD
- Phone Number: 5058110022
- Email: dkaloglu@artvin.edu.tr
Study Contact Backup
- Name: Enes BULUT
- Phone Number: 5464213863
- Email: bulutts61@artvin.edu.tr
Study Locations
-
-
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Artvin, Turkey, 08000
- Recruiting
- Artvin State Hospital
-
Contact:
- Dilek KALOĞLU BİNİCİ, PhD
- Phone Number: 5058110022
- Email: dkaloglu@artvin.edu.tr
-
Contact:
- Enes BULUT, PhD
- Phone Number: 5464213863
- Email: bulutts61@artvin.edu.tr
-
Principal Investigator:
- Hava ÖZKAN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Routine care
|
|
|
Experimental: Experimental group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
"change" is being assessed. up to 10-12 hours after cesarean section
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
in the morning the day after the cesarean section
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilek KALOĞLU BİNİCİ, PhD, Artvin Coruh University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Gum after cesarean section
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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