OperationNCT06359223
Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section:
A study testing coffee consumption in people with Operation and Cesarean Section, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Operation, Cesarean Section
- What is being tested?
- coffee consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Operation, Cesarean Section
- Being tested
- coffee consumption, control group
- Keywords
- Caesarean Section, Coffee, pain, Motility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffee consumptionDietary supplement
After cesarean section, patients will be allowed to drink coffee.
control groupOther
Patients will undergo a routine surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 6 hour
intestinal motility
24 hour. The patient's bowel sounds will be listened to during the hours
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start20 May 2024
- Primary completion15 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OperationStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- KTO Karatay University
- Responsible party
- Principal investigator, HÜMEYRA YÜKSEL, TC Erciyes University
- Investigators
- HÜMEYRA YÜKSEL, Phd, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359223
- Sponsor's protocol ID
- 2400602
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study can be shared by researchers with permission.
Publications
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.
PubMed 34401138Abadi 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.
PubMed 28483182undefined
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.
PubMed 27063604Khadem 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.
PubMed 21589777Souza 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.
PubMed 26259689Tuzmen 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.
PubMed 40967073
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Consumption on Postoperative Pain and Intestinal Motility After Caesarean Section: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06359223
- Acronym / sponsor ID
- 2400602
- Conditions
- Operation, Cesarean Section
- Keywords
- Caesarean Section, Coffee, pain, Motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- KTO Karatay University
- Study start
- 20 May 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caffeine group | Experimental | Dietary Supplement: coffee consumptionParticipants 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. |
| control group | Active comparator | Other: control groupThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coffee consumptionAfter cesarean section, patients will be allowed to drink coffee. | Dietary supplement | caffeine group |
| control groupPatients will undergo a routine surgical procedure. | Other | control group |
Primary outcome
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".
intestinal motility
Time frame: 24 hour
24 hour. The patient's bowel sounds will be listened to during the hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 34401138Zamanabadi 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.
- Background: PubMed 28483182Abadi 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.
- Backgroundundefined
- Results publicationGoymen, 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.
- Results publicationTian YT. 2017. China is not"The World's First Cesarean Section Rate".Beijing: Guangming Daily.
- Results publication: PubMed 27063604Curran 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.
- Results publication: PubMed 21589777Khadem 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.
- Results publication: PubMed 26259689Souza 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.
- Derived from this study: PubMed 40967073Tuzmen 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.
- Individual participant dataSharing planned: No. The data of the study can be shared by researchers with permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HÜMEYRA YÜKSEL, Phd principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coffee consumption in people with Operation and Cesarean Section, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 6 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06359223, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.