Gastrointestinal MotilityNCT07369726
Post-Cesarean Caffeine: Pain and Recovery
A study testing caffeine consumption and Decaffeinated coffee in people with Gastrointestinal Motility and Postoperative Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
This study Maims to assess bowel motility, pain and psychological well-being in women in the post-cesarean period by mobilizing them early and encouraging them to consume coffee. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility, Postoperative Pain, Psychological Well-Being
- What is being tested?
- caffeine consumption and Decaffeinated coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 29 Oct 2026
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 18 and 35 years of age,
- Women who underwent cesarean delivery under spinal anesthesia,
- Having a post-cesarean pain level of 4 or higher,
- Being able to understand and write Turkish and communicate effectively with researchers.
Who cannot join
- Women who underwent emergency cesarean delivery,
- Those with pregnancy complications (preeclampsia, placenta previa, etc.),
- Those with a history of chronic gastrointestinal disease (e.g., irritable bowel syndrome, Crohn's disease, ulcerative colitis),
- Those with sensitivity or allergy to caffeine,
- Those with a history of chronic pain syndrome or dependence on analgesics,
- Regular coffee drinkers (≥2 cups per day),
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- Intraoperative complications such as bowel or bladder injury,
- Those who cannot comply with the study protocol or complete the follow-up process.
- Removal Criteria:
- Participants are excluded from the study under the following conditions:
- During surgery If complications occur (e.g., bladder or bowel injury, excessive bleeding),
- Postoperative complications requiring admission to the intensive care unit (ICU) for the mother or newborn,
- Development of severe postoperative nausea, vomiting, or intolerance to oral intake,
- Inability to consume or refusal to consume coffee according to the study protocol,
- Withdrawal of consent by the participant at any point during the study,
- Failure to comply with surgical procedures or loss of follow-up,
- Development of medical conditions during follow-up that may affect study results (e.g., acute infections, neurological disorders).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Caffeine Consumption After Cesarean Section on Pain, Bowel Motility, and Time to Discharge: A Randomized Controlled Study
This study Maims to assess bowel motility, pain and psychological well-being in women in the post-cesarean period by mobilizing them early and encouraging them to consume coffee.
Read the detailed description
In the intervention group, the goal is to initiate bowel motility by mobilizing women early in the post-cesarean period. This increased bowel motility will facilitate gas expulsion, thus minimizing pain levels. Caffeine consumption will help keep pain levels at a minimum. By minimizing pain, women will experience positive psychological well-being.
- Being tested
- caffeine consumption, Decaffeinated coffee
- Keywords
- gastrointestinal motility, postoperatif pain, Psychological Well-Being, Early Ambulation
- Medical subject headings
- Pain, Postoperative, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine consumptionDietary supplement
The women in the intervention group will be mobilised at the 4-hour mark. The intervention group will be given caffeinated Turkish coffee at 6-hour intervals.
Decaffeinated coffeeDietary supplement
The women in the control group will be mobilised at the 6-hour mark. The control group will be given decaffeinated Turkish coffee at 6-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Women in the control group will receive routine intervention. They will be mobilized at 6 hours. Decaffeinated coffee will be served at 6-hour intervals. Receives: Dietary Supplement: Decaffeinated coffee |
| intervention group | Experimental | They will be mobilized at 4 hours.They will consume Turkish coffee containing caffeine every six hours. Receives: Dietary Supplement: caffeine consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain after caesarean section within 24 hours from baseline
Pain will be assessed using a 10 cm visual analogue scale. '0' means no pain, while '10' means unbearable pain. The assessment will be carried out at the start of the study, at 6-hour intervals, and at the end.
Measured: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Change in postoperative Bowel Motility after caesarean section within 24 hours from baseline
Bowel motility will be assessed using BFI. The Bowel Function Index (BFI) is a short and practical measure used to assess constipation, particularly in patients using opioids. It consists of three questions, each scored on a scale of 0 to 100. These scores are used to measure the degree of bowel dysfunction.
Measured: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Change in postoperative Psychological Well-being after caesarean section within 24 hours from baseline
Psychological Well-being will be assessed using Psychological Well-Being Scale. Based on the score obtained: 1.00-2.99 → Low psychological resilience, 3.00-4.30 → Moderate level, 4.31-5.00 → High psychological resilience.
Measured: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start25 Nov 2025
- Primary completion16 Aug 2026
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MotilityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafize Dağ Tüzmen, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369726
- Sponsor's protocol ID
- AIBU-EBE-EK-01
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine Consumption After Cesarean Section on Pain, Bowel Motility, and Time to Discharge: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07369726
- Acronym / sponsor ID
- AIBU-EBE-EK-01
- Keywords
- gastrointestinal motility, postoperatif pain, Psychological Well-Being, Early Ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 27 Jan 2026 (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.
This study Maims to assess bowel motility, pain and psychological well-being in women in the post-cesarean period by mobilizing them early and encouraging them to consume coffee.
Detailed description
In the intervention group, the goal is to initiate bowel motility by mobilizing women early in the post-cesarean period. This increased bowel motility will facilitate gas expulsion, thus minimizing pain levels. Caffeine consumption will help keep pain levels at a minimum. By minimizing pain, women will experience positive psychological well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: Decaffeinated coffeeWomen in the control group will receive routine intervention. They will be mobilized at 6 hours. Decaffeinated coffee will be served at 6-hour intervals. |
| intervention group | Experimental | Dietary Supplement: caffeine consumptionThey will be mobilized at 4 hours.They will consume Turkish coffee containing caffeine every six hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between 18 and 35 years of age,
- Women who underwent cesarean delivery under spinal anesthesia,
- Having a post-cesarean pain level of 4 or higher,
- Being able to understand and write Turkish and communicate effectively with researchers.
Key exclusion criteria (17 listed)
- Women who underwent emergency cesarean delivery,
- Those with pregnancy complications (preeclampsia, placenta previa, etc.),
- Those with a history of chronic gastrointestinal disease (e.g., irritable bowel syndrome, Crohn's disease, ulcerative colitis),
- Those with sensitivity or allergy to caffeine,
- Those with a history of chronic pain syndrome or dependence on analgesics,
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 |
|---|---|---|
| caffeine consumptionThe women in the intervention group will be mobilised at the 4-hour mark. The intervention group will be given caffeinated Turkish coffee at 6-hour intervals. | Dietary supplement | intervention group |
| Decaffeinated coffeeThe women in the control group will be mobilised at the 6-hour mark. The control group will be given decaffeinated Turkish coffee at 6-hour intervals. | Dietary supplement | Control Group |
Primary outcome
Change in postoperative pain after caesarean section within 24 hours from baseline
Time frame: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Pain will be assessed using a 10 cm visual analogue scale. '0' means no pain, while '10' means unbearable pain. The assessment will be carried out at the start of the study, at 6-hour intervals, and at the end.
Change in postoperative Bowel Motility after caesarean section within 24 hours from baseline
Time frame: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Bowel motility will be assessed using BFI. The Bowel Function Index (BFI) is a short and practical measure used to assess constipation, particularly in patients using opioids. It consists of three questions, each scored on a scale of 0 to 100. These scores are used to measure the degree of bowel dysfunction.
Change in postoperative Psychological Well-being after caesarean section within 24 hours from baseline
Time frame: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Psychological Well-being will be assessed using Psychological Well-Being Scale. Based on the score obtained: 1.00-2.99 → Low psychological resilience, 3.00-4.30 → Moderate level, 4.31-5.00 → High psychological resilience.
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine consumption and Decaffeinated coffee in people with Gastrointestinal Motility and Postoperative Pain, run by KTO Karatay 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 17 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 2 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
Change in postoperative pain after caesarean section within 24 hours from baseline (time frame: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.