NCT05980975

Brief Summary

The aim of this study is to examine the effects of coffee and hot water consumption on gastrointestinal system functions after cesarean section performed under general anesthesia. The study is in a randomized controlled experimental design. The sample of the study consisted of 25 participants in the coffee group (Group 1), 26 participants in the hot water group (Group 2) and 27 participants in the control group (Group 3). After cesarean section, at the 4th, 8th and 12th hours of the operation, the first intervention group (coffee group) received 2 gr. granulated coffee, the second intervention group (hot water group) was given 100 ml of 50-60 C0 sugar-free hot water, the third group (control group) was given no intervention other than routine applications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

July 14, 2023

Last Update Submit

August 7, 2023

Conditions

COFFEEGastrointestinal Motility and Defecation Conditions

Keywords

cesarean sectioncoffeebowel soundflatulence

Outcome Measures

Primary Outcomes (2)

  • First bowel sound time listened with stethoscope

    After cesarean section, the four quadrants of the abdomen were listened to every hour for the first 12 hours and every 4 hours for the next 12 hours by the investigator, and the first bowel sound time was determined by the investigator.

    24 hours

  • First gas output, first defecation output, nausea and vomiting by the patient's statement checklist

    Nausea, vomiting, first gas and first defecation times were determined by the patient's statement.

    24 hours

Study Arms (3)

Coffee group (Group 1)

EXPERIMENTAL

Then, at the 4th hour, 8th hour and 12th hour of the surgery, the patients in the coffee group received 10 gr. granulated coffee.

Other: Coffee

Hot water group (Group 2)

EXPERIMENTAL

The patients in the hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of the operation.

Other: Hot water

Control group (Group 3)

NO INTERVENTION

No application was made to the control group.

Interventions

CoffeeOTHER

4th hour, 8th hour and 12th hour of after the surgery, the patients in the coffee group received 10 gr. granulated coffee.

Coffee group (Group 1)
Hot waterOTHER

hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of after the operation

Hot water group (Group 2)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCesarean section is performed only on women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cesarean section performed by the physician determined in the research
  • Over 18 years old,
  • Completing the 37. gestational week,
  • Do not have any gastrointestinal system disease that may affect the results of the research and do not use drugs,
  • Able to understand and speak Turkish,
  • Women who voluntarily participated in the study

You may not qualify if:

  • Cesarean section performed by a different physician than the physician determined in the study.
  • Younger than 18,
  • Not completing the 37.gestational week
  • Having any gastrointestinal system disease that may affect the research results and using medication
  • Can't understand or speak Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatulence

Interventions

Coffee

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer doctor

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 8, 2023

Study Start

February 1, 2022

Primary Completion

February 1, 2022

Study Completion

July 15, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

TU(1)