- 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
Objective The aim of this study was to investigate whether postoperative coffee intake affects pain levels and bowel motility in women undergoing cesarean delivery.
Design: It will be conducted as a randomized controlled experimental study. Method: It is a randomized controlled experimental study: This randomized controlled clinical trial will be conducted between May and December 2024 in accordance with the Consolidated Standards of Reporting Trials. A total of 60 women will be randomly assigned to the intervention group (n=30) or the control group (n=30). Participants in the intervention group will receive 100 mg caffeine in coffee at 6 and 12 hours after surgery in addition to routine postoperative care. The control group will receive only routine postoperative care. Pain will be assessed using Visual Analog Scale (VAS) and bowel activity will be monitored by time to first defecation, gas passage and bowel sounds.
Keywords: Caesarean section, Coffee, Pain, Motility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey, 42000
- KTO Karatay Unıversty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- had a cesarean delivery with spinal anesthesia,
- had a postoperative pain level of 4 or higher,
- could read and write Turkish,
- could communicate effectively with the researchers.
Exclusion Criteria:
- Those who underwent emergency cesarean section,
- Those with pregnancy complications (e.g., preeclampsia, gestational diabetes, placenta previa),
- Those with a history of chronic gastrointestinal disease (e.g., irritable bowel syndrome, Crohn's disease, ulcerative colitis),
- Those with caffeine sensitivity or allergy,
- Those with chronic pain syndrome or analgesic dependence,
- Those who regularly consume coffee (≥2 cups per day),
- Those who experienced intraoperative complications (e.g., bowel or bladder injury),
- Those who could not comply with the study protocol.
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 in the intervention group will receive 100 mg caffeine in coffee at 6 and 12 hours after surgery in addition to routine postoperative care.
The control group will receive only routine postoperative care.
Pain will be assessed using Visual Analog Scale (VAS) and bowel activity will be monitored by time to first defecation, gas passage and bowel sounds.
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After cesarean section, patients will be allowed to drink coffee.
|
|
Active Comparator: control group
The control group will receive only routine postoperative care.
Pain will be assessed using Visual Analog Scale (VAS) and bowel activity will be monitored by time to first defecation, gas passage and bowel sounds.
|
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: 6 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".
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6 hour
|
|
intestinal motility
Time Frame: 24 hour
|
24 hour.
The patient's bowel sounds will be listened to during the hours
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24 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: HÜMEYRA YÜKSEL, Phd, 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 (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
product manufactured in and exported from the U.S.
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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