The Effect of Coffee and Hot Water on Gastroıntestınal Functıons

• ClinicalTrials.gov Identifier: NCT05980975
• Recruitment Status: Completed
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Mersin University
• Information provided by (Responsible Party): Seher Gürdil Yılmaz, Mersin University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COFFEE; Gastrointestinal Motility and Defecation Conditions	Other: Coffee; Other: Hot water	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Coffee and Hot Water Consumptıon on Gastroıntestınal System Functıons After Cesarrean Sectıon
• Actual Study Start Date: February 1, 2022
• Actual Primary Completion Date: February 1, 2022
• Actual Study Completion Date: July 15, 2023

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cesarean section is performed only on women.
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Turkey

Mersin University

Mersin, Turkey

Sponsors and Collaborators

Mersin University

More Information

• Responsible Party: Seher Gürdil Yılmaz, Lecturer doctor, Mersin University
• ClinicalTrials.gov Identifier: NCT05980975
• Other Study ID Numbers: MersinUniversityy
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seher Gürdil Yılmaz, Mersin University:

cesarean section; coffee; bowel sound; flatulence