NCT06359223

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

April 1, 2024

Last Update Submit

July 9, 2025

Conditions

Keywords

Caesarean SectionCoffeepainMotility

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain

    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".

    6 hour

  • intestinal motility

    24 hour. The patient's bowel sounds will be listened to during the hours

    24 hour

Study Arms (2)

caffeine group

EXPERIMENTAL

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.

Dietary Supplement: coffee consumption

control group

ACTIVE COMPARATOR

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.

Other: control group

Interventions

coffee consumptionDIETARY_SUPPLEMENT

After cesarean section, patients will be allowed to drink coffee.

caffeine group

Patients will undergo a routine surgical procedure.

control group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay Unıversty

Konya, Karatay, 42000, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 34401138BACKGROUND
  • 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.

    PMID: 28483182BACKGROUND
  • undefined

    BACKGROUND
  • 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.

    RESULT
  • Tian YT. 2017. China is not"The World's First Cesarean Section Rate".Beijing: Guangming Daily.

    RESULT
  • 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.

  • Tuzmen HD, Yuksel H, Yazar M, Sayar S, Horasanli JE. The effect of coffee consumption on postoperative pain and bowel motility following cesarean section: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2025 Nov;314:114723. doi: 10.1016/j.ejogrb.2025.114723. Epub 2025 Sep 13.

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • HÜMEYRA YÜKSEL, Phd

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 11, 2024

Study Start

May 20, 2024

Primary Completion

September 15, 2024

Study Completion

December 30, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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

Locations