Evaluation the Effects of Chewing Gum

August 11, 2026 updated by: Pınar AKBAŞ, Karabuk University

Evaluating the Effects of Chewing Gum on Bowel Function, Postpartum Comfort and Satisfaction With Caesarean Birth: A Randomized Controlled Trial

This study was conducted as a randomized controlled trial to evaluate the effects of gum chewing in the early postpartum period on bowel function, postpartum comfort, and postpartum satisfaction in women. The sample consisted of 66 women, 33 in the experimental group and 33 in the control group. Data were collected using a pre-assessment form, a demographic information form, a bowel function monitoring form, a postpartum comfort scale, and a maternal satisfaction scale (cesarean delivery). While the control group received no intervention other than standard postoperative care, the experimental group underwent gum chewing at 4, 6, and 8 hours postpartum.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Karabük, Turkey (Türkiye), 78100
        • Karabuk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18-45 years
  • Women who underwent cesarean section under epidural or spinal anesthesia

Exclusion Criteria:

  • Cesarean delivery under general anesthesia
  • Jaw or oral membrane problems that may prevent chewing gum
  • Any systemic or chronic disease
  • Any mental or psychiatric illness
  • History of chronic constipation
  • Any communication problems, including mental, auditory, or visual impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: chewing gum group
Other: chewing gum
In addition to routine post-cesarean care, women in the experimental group were given commercially available sugar-free, aspartame-free, sorbitol-free, xylitol-free, soft, and easy-to-chew gum to chew from the 4th hour post-operatively until they switched to Diet I. Since oral feeding was started at the 6th hour in the clinic where the study was conducted, women in the experimental group were given gum to chew at the 4th, 6th, and 8th hours after cesarean section, with each chewing session lasting between 15 and 30 minutes. The women were instructed to chew their gum at the 6th hour post-cesarean and then drink water before starting oral feeding. The gum used in one period was not repeated in the next period; a new pack of gum was used. In this way, each woman chewed a total of 3 pieces of gum.
No Intervention: no initiative

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bowel motility (time to pass gas and stool)
Time Frame: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
Maternal Satisfaction With Caesarean Birth Measured Using the Scale for Measuring Maternal Satisfaction-Caesarean Birth
Time Frame: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
This measurement was evaluated using the Maternal Satisfaction Assessment Scale at Birth (Cesarean Birth). Developed by Güngör and Beji (2009) to assess the experiences of women in the early postpartum period after cesarean delivery, this scale consists of 42 items on a 5-point Likert scale with 10 sub-dimensions: perception of the healthcare team, preparation for cesarean section, reassurance, participation in decision-making and information sharing, meeting the baby, postpartum care, hospital room, hospital facilities, respect for privacy, and meeting expectations. Each item on the scale is scored between 1 (strongly disagree) and 5 (strongly agree). Twelve items (8, 9, 10, 19, 20, 21, 22, 34, 35, 37, 40, 41) are reverse-scored. The highest possible score is 210, and the lowest is 42. As the score on the scale increases, the level of satisfaction also increases.
2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
Postpartum Comfort Level Measured Using the Postpartum Comfort Scale (PCS)
Time Frame: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
This measurement was evaluated using the Postpartum Comfort Scale. It is a scale developed by Karakaplan and Yıldız, based on Kolcaba's general comfort scale, and adapted for our country. It was developed to evaluate the comfort of women who have had cesarean and vaginal deliveries. The scale consists of 34 items with 3 sub-dimensions: sociocultural, psychospiritual, and physical, using a 5-point Likert scale. Each item is scored between 1 (strongly disagree) and 5 (strongly agree). The highest possible score on the scale is 170, and the lowest is 34. The Postpartum Comfort Scale and sub-dimension scores are evaluated based on the total score, and as the score increases, the comfort level of the women increases.
2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karabuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-KAEK-82
  • KBÜBAP-25-YL-030 (Other Grant/Funding Number: Karabük University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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