NCT07125742

Brief Summary

This randomized controlled trial aims to evaluate the effects of chewing gum, fennel tea, and ginger tea consumption on intestinal motility and postpartum comfort in women following cesarean section. The primary research questions to be answered are: Do chewing gum, fennel tea, or ginger tea accelerate the onset of bowel sounds after cesarean section? Do these interventions affect the time to first gas passage, defecation, and feeling of hunger? Are there differences among these interventions in terms of their impact on abdominal distension and postpartum comfort? Researchers will compare the effects of the interventions between three groups: chewing gum, fennel tea, and ginger tea. Participants: Women who underwent cesarean section and voluntarily agreed to participate in the study. A total of 96 participants were randomly assigned into three groups of 32 each. Interventions and procedures: Starting 6 hours after cesarean section (following first oral fluid intake), at the 8th and 10th hours: The chewing gum group was asked to chew sugar-free gum for 15 minutes at each time point. The fennel tea group received 2 g of fennel steeped in 150 ml boiling water for 10 minutes. The ginger tea group received 2 g of fresh ginger steeped in 150 ml boiling water for 10 minutes. Bowel sounds were auscultated before and 60 minutes after each intervention. The time of first gas passage, first defecation, and first feeling of hunger was recorded. Abdominal distension was assessed using a Visual Analog Scale (VAS) six times in total (before and 60 minutes after each intervention). Postpartum Comfort Scale was applied to all participants at the 12th hour post-cesarean. All data were collected by the researchers. Randomization was supported by a healthcare professional not involved in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

November 18, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

August 6, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

WomenFennelChewing GumGingerCesarean

Outcome Measures

Primary Outcomes (2)

  • Assessment of postoperative abdominal distension severity following cesarean section using the Visual Analog Scale (VAS)

    In this study, the primary outcome is the determination of the severity of abdominal distension after cesarean section using the Visual Analog Scale (VAS). VAS is a subjective tool frequently used in epidemiological and clinical research to measure the intensity of various symptoms, particularly pain. Its validity and reliability have been previously established. The scale used in this study is the simplest vertical form, 10 cm in length. In other words, the number 0 represents "no abdominal distension", while the number 10 indicates "the worst level of abdominal distension." Using this scale, participants were asked to assess the severity of their abdominal distension.

    Postoperative 6th, 7th, 8th, 9th, 10th, and 11th hours

  • Evaluation of the time to return of postoperative intestinal motility

    Postoperative intestinal motility: In all groups, the times to first bowel movement, first flatus, first defecation, and first sensation of hunger after cesarean section were evaluated.

    Postoperative 48 hour

Secondary Outcomes (1)

  • Assessment of the Postnatal Comfort Scale

    Postoperative 12 hour

Study Arms (4)

Chewing gum

EXPERIMENTAL

Starting 6 hours after cesarean section (following first oral fluid intake), at the 8th and 10th hours: The chewing gum group was asked to chew sugar-free gum for 15 minutes at each time point.

Other: Chewing gum

Fennel Tea

EXPERIMENTAL

Starting 6 hours after cesarean section (following first oral fluid intake), at the 8th and 10th hours: fennel tea group received 2 g of fennel steeped in 150 ml boiling water for 10 minutes.

Other: Fennel Tea

Ginger Tea

EXPERIMENTAL

Starting 6 hours after cesarean section (following first oral fluid intake), at the 8th and 10th hours: The ginger tea group received 2 g of fresh ginger steeped in 150 ml boiling water for 10 minutes.

Other: Ginger Tea

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

The chewing gum group was asked to chew sugar-free gum for 15 minutes at each time point.

Chewing gum

Fennel Tea: The fennel tea group received 2 g of fennel steeped in 150 ml boiling water for 10 minutes.

Fennel Tea

Ginger Tea: The ginger tea group received 2 g of fresh ginger steeped in 150 ml boiling water for 10 minutes.

Ginger Tea

Eligibility Criteria

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

You may qualify if:

  • The participant mother's voluntary participation in the study and provision of written and verbal informed consent,
  • Having undergone general anesthesia,
  • Having at least basic reading and writing skills,
  • Being between 38-42 gestational weeks,
  • According to the mother's statement and medical records, having no history of asthma, liver disease, cancer, epilepsy, or similar conditions,
  • No history of allergies,
  • Body Mass Index (BMI) between 18.50-24.99 kg/m².

You may not qualify if:

  • The participant mother's unwillingness to continue cooperating in the study,
  • Having received spinal anesthesia,
  • Being under 18 years of age,
  • Being over 45 years of age,
  • Inability to chew gum,
  • Experiencing nausea or similar side effects during the consumption of fennel or ginger,
  • The mother's refusal to consume fennel or ginger tea or to chew gum during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak University

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatulence

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Şeyma ÇATALGÖL, Dr

    Uşak University, Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 15, 2025

Study Start

November 18, 2024

Primary Completion

August 16, 2025

Study Completion

August 16, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations