The Effect of Coffee and Hot Water on Gastroıntestınal Functıons

August 7, 2023 updated by: Seher Gürdil Yılmaz, Mersin University

The Effect of Coffee and Hot Water Consumptıon on Gastroıntestınal System Functıons After Cesarrean Sectıon

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.

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.

Detailed Description

Objective: 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.

Materials and Methods: The study is in a randomized controlled experimental design. Patients who had an uncomplicated cesarean section under general anesthesia, were older than 18 years of age, completed the 37th week of pregnancy, did not have any gastrointestinal system disease that could affect the results of the study, and did not use drugs, and who could understand and speak Turkish were included in the study. 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.

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.
77

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
      • Mersin, Turkey
        • Mersin University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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: Double

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: Coffee group (Group 1)
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
4th hour, 8th hour and 12th hour of after the surgery, the patients in the coffee group received 10 gr. granulated coffee.
Experimental: Hot water group (Group 2)
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
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
No Intervention: Control group (Group 3)
No application was made to the control group.

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
First bowel sound time listened with stethoscope
Time Frame: 24 hours
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
Time Frame: 24 hours
Nausea, vomiting, first gas and first defecation times were determined by the patient's statement.
24 hours

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.
Mersin 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.
February 1, 2022

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.
February 1, 2022

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.
July 15, 2023

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).
July 14, 2023

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 7, 2023

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 8, 2023

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 8, 2023

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 7, 2023

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, 2023

More Information

Terms related to this study

Keywords

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.
  • MersinUniversityy

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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