NCT07764367

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 2, 2026

Last Update Submit

August 11, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Bowel motility (time to pass gas and stool)

    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

    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)

    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).

Study Arms (2)

chewing gum group

EXPERIMENTAL
Other: chewing gum

no initiative

NO INTERVENTION

Interventions

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.

chewing gum group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk Training and Research Hospital

Karabük, 78100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 13, 2026

Study Start

December 10, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations