Clinical trial NCT05945095: The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
Official title: The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mothers
Cesarean Section Complications
Keywords: General anesthesia,
Sleep Quality
Chewing Gum, Pain,
Cesarean section,
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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:

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: "change" is being assessed. up to 10-12 hours after cesarean section
Secondary outcomes:
measure: Richard-Campbell Sleep Scale (RCUI)
timeFrame: in the morning the day after the cesarean section
Other outcomes:
Locations:
city: Artvin
country: Turkey
facility: Artvin State Hospital
Study officials:
affiliation: Artvin Coruh University
name: Dilek KALOĞLU BİNİCİ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.