Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section:

April 5, 2024 updated by: HÜMEYRA YÜKSEL, TC Erciyes University

Effect of Coffee Consumption on Postoperative Pain and Intestinal Motility After Caesarean Section: Randomized Controlled Study

Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.

Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women's pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours.

Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section.

Key Words: Caesarean Section, Coffee, Pain, Motility

Study Overview

Status

Not yet recruiting

Detailed Description

Cesarean section is one of the most common surgical operations in obstetrics and gynecology. While the caesarean section rate is 25-40% in developed countries such as the United States, Ireland, England and China, this rate is 48% in Turkey. For this reason, post-cesarean pain and delayed bowel motility are among the common problems due to the surgical intervention. Post-cesarean pain can delay return to normal daily activities and negatively affect the mother's psychological health, breastfeeding, and mother-infant bonding. In addition to pain, delayed bowel motility due to changes in the autonomic nervous system is among the most common problems experienced after cesarean section. Appropriate health care provided by medical personnel during the postpartum period can enable the woman to be discharged early. Therefore, non-invasive, low-cost and uncomplicated methods should be preferred to reduce pain in the postoperative period and ensure the first spontaneous passing of gas and early defecation. In the literature review, although there is no study determining the effect of drinking coffee on pain in the postoperative period, there are studies stating that coffee can contribute to early GI motility in the postoperative period after abdominal surgery and shorten the time for passing gas, defecation and discharge. Therefore, this research will be conducted as a randomized controlled experimental study with the aim of minimizing the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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 Contact

Study Contact Backup

Study Locations

    • Karatay
      • Konya, Karatay, Turkey, 42000
        • KTO Karatay Unıversty
        • Principal Investigator:
          • HÜMEYRA YÜKSEL, Ph.D Student
        • Sub-Investigator:
          • Hafize Tüzmen, Ph.D student
        • Sub-Investigator:
          • Merve Yazar, Ph.D student
        • Sub-Investigator:
          • Jule Horasanlı, MD
        • Sub-Investigator:
          • Serap Sayar, Assis. Prof.

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Giving birth by cesarean section under spinal anesthesia,
  • Postoperative pain intensity of 4 or more,
  • Within the first 48 hours after surgery
  • 4 hours have passed since the first analgesia was administered to women who came to the clinic after cesarean section.

Exclusion Criteria:

  • Complicated birth
  • Development of any complications after surgery

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: caffeine group
Participants who meet the inclusion criteria after cesarean section and are assigned to the caffeinated coffee group by randomization method will be informed about the research and their verbal and written consent will be obtained. Immediately before coffee application (6-12-18 hours after surgery), women's pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. At the same time, the women's bowel sounds, gas passing and defecation will be recorded during these hours.
After cesarean section, patients will be allowed to drink coffee.
Active Comparator: control group
No application will be made to the participants in this group. After the cesarean section, women will be evaluated for pain with VAS at 6-12-18 hours and half an hour after 6-12-18 hours, and their bowel sounds, flatulence and defecation will be recorded.
Patients will undergo a routine surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 24 hour
The visual analog scale (VAS ) is a scale with different names at both ends on a 10 cm long vertical or horizon line. In this study, evaluation was made as "0 = no pain" and "10 = the most severe pain".
24 hour
intestinal motility
Time Frame: 24 hour
6-12-18. The patient's bowel sounds will be listened to during the hours
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: HÜMEYRA YÜKSEL, KTO Karatay University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 20, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2400602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data of the study can be shared by researchers with permission.

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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