NCT07369726

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 19, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

gastrointestinal motilitypostoperatif painPsychological Well-BeingEarly Ambulation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours

Study Arms (2)

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.

Dietary Supplement: Decaffeinated coffee

intervention group

EXPERIMENTAL

They will be mobilized at 4 hours.They will consume Turkish coffee containing caffeine every six hours.

Dietary Supplement: caffeine consumption

Interventions

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.

intervention group
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.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 18-35
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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),
  • Intraoperative complications such as bowel or bladder injury,
  • i) 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42208, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePsychological Well-Being

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Hafize D Dağ TÜZMEN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTORAL PROFESSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 27, 2026

Study Start

November 25, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations