- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07764367
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- 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
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Karabük, Turkey (Türkiye), 78100
- Karabuk Training and Research Hospital
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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
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 |
Intervention / Treatment |
|---|---|
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Experimental: chewing gum group
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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.
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No Intervention: no initiative
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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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.
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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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).
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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.
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 10, 2024
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
August 2, 2026
First Submitted That Met QC Criteria
August 11, 2026
First Posted (Actual)
August 13, 2026
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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