CClinicalTrials.gg
RecruitingNCT05945095Updated Jul 14, 2023

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

An interventional study of Gum chewing group in Mothers and Cesarean Section Complications, sponsored by Artvin Coruh University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by Artvin Coruh University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Mothers
  • Cesarean Section Complications

Keywords

  • General anesthesia,
  • Sleep Quality
  • Chewing Gum, Pain,
  • Cesarean section,
03

In context

Lead sponsor

Artvin Coruh University is the lead sponsor of 26 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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:
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Gum chewing group

    Other: Gum chewing group

  • No intervention
    Control group

    Routine care

Interventions

  • OtherGum 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.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS)

    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

    Time frame: "change" is being assessed. up to 10-12 hours after cesarean section

Secondary outcomes

  1. Richard-Campbell Sleep Scale (RCUI)

    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.

    Time frame: in the morning the day after the cesarean section

07

Study locations

1 of 1 sites recruiting
  • Artvin State Hospital
    Artvin, 08000, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27747876 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05945095
Lead sponsor
Artvin Coruh University
Responsible party
Dilek Kaloglu Binici (Principal Investigator (PhD Research Nurse), Artvin Coruh University) — Principal investigator
First posted
Jul 14, 2023
Start date
Mar 27, 2023
Primary completion
Dec 27, 2023 (estimated)
Completion
May 20, 2024 (estimated)
Last update
Jul 14, 2023

Study contacts

Dilek KALOĞLU BİNİCİ, PhD
Contact
dkaloglu@artvin.edu.tr
5058110022
Enes BULUT
Contact
bulutts61@artvin.edu.tr
5464213863
Dilek KALOĞLU BİNİCİ, PhD
principal investigator · Artvin Coruh University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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