- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359223
Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section:
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HÜMEYRA YÜKSEL, phd student
- Phone Number: +90 539 854 27 09
- Email: humeyragecici@gmail.com
Study Contact Backup
- Name: Hafize Dağ Tüzmen, phd student
- Email: hafizem1992@gmail.com
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey, 42000
- KTO Karatay Unıversty
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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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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Patients will undergo a routine surgical procedure.
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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
Sponsor
Investigators
- Principal Investigator: HÜMEYRA YÜKSEL, KTO Karatay University
Publications and helpful links
General Publications
- undefined
- Zamanabadi MN, Alizadeh R, Gholami F, Seyed Mehdi SA, Aryafar M. Effect of caffeine on postoperative bowel movement and defecation after cesarean section. Ann Med Surg (Lond). 2021 Aug 6;68:102674. doi: 10.1016/j.amsu.2021.102674. eCollection 2021 Aug.
- Abadi F, Shahabinejad M, Abadi F, Kazemi M. Effect of Acupressure on Symptoms of Postoperative Ileus After Cesarean Section. J Acupunct Meridian Stud. 2017 Apr;10(2):114-119. doi: 10.1016/j.jams.2016.11.008. Epub 2016 Dec 27.
- Goymen, A., Simsek, Y., Ozkaplan, S. E., Ozdurak, H. I., Akpak, Y. K., Semiz, A., & Oral, S. (2017). Effect of gum chewing and coffee consumption on intestinal motility in caesarean sections.
- Tian YT. 2017. China is not"The World's First Cesarean Section Rate".Beijing: Guangming Daily.
- Curran EA, Khashan AS, Dalman C, Kenny LC, Cryan JF, Dinan TG, Kearney PM. Obstetric mode of delivery and attention-deficit/hyperactivity disorder: a sibling-matched study. Int J Epidemiol. 2016 Apr;45(2):532-42. doi: 10.1093/ije/dyw001. Epub 2016 Apr 10.
- Khadem N, Khadivzadeh T. The intelligence quotient of school aged children delivered by cesarean section and vaginal delivery. Iran J Nurs Midwifery Res. 2010 Summer;15(3):135-40.
- Souza JP, Betran AP, Dumont A, de Mucio B, Gibbs Pickens CM, Deneux-Tharaux C, Ortiz-Panozo E, Sullivan E, Ota E, Togoobaatar G, Carroli G, Knight H, Zhang J, Cecatti JG, Vogel JP, Jayaratne K, Leal MC, Gissler M, Morisaki N, Lack N, Oladapo OT, Tuncalp O, Lumbiganon P, Mori R, Quintana S, Costa Passos AD, Marcolin AC, Zongo A, Blondel B, Hernandez B, Hogue CJ, Prunet C, Landman C, Ochir C, Cuesta C, Pileggi-Castro C, Walker D, Alves D, Abalos E, Moises E, Vieira EM, Duarte G, Perdona G, Gurol-Urganci I, Takahiko K, Moscovici L, Campodonico L, Oliveira-Ciabati L, Laopaiboon M, Danansuriya M, Nakamura-Pereira M, Costa ML, Torloni MR, Kramer MR, Borges P, Olkhanud PB, Perez-Cuevas R, Agampodi SB, Mittal S, Serruya S, Bataglia V, Li Z, Temmerman M, Gulmezoglu AM. A global reference for caesarean section rates (C-Model): a multicountry cross-sectional study. BJOG. 2016 Feb;123(3):427-36. doi: 10.1111/1471-0528.13509. Epub 2015 Aug 10.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2400602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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