NCT07410741

Brief Summary

The purpose of this study is to investigate the effects of postoperative coffee consumption on postdural puncture headache (PDPH) and analgesic use in women undergoing cesarean section with spinal anesthesia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2026

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 Progress41%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 7, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Post-Dural Puncture Headachespinal anesthesiacaffeinecesarean sectioncoffee

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postdural Puncture Headache

    Incidence of postdural puncture headache will be determined based on the presence or absence of headache at any scheduled assessment during the assessment period, as reported by participants.

    From postoperative hour 6 through postoperative day 5

Secondary Outcomes (3)

  • Severity of Postdural Puncture Headache

    From postoperative hour 6 through postoperative day 5

  • Postoperative Analgesic Use

    From postoperative hour 6 through postoperative day 5

  • Patient Satisfaction Level

    Once prior to hospital discharge

Study Arms (2)

Coffee Consumption Group

EXPERIMENTAL

Participants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia.

Dietary Supplement: Coffee Consumption

Standard Care Control Group

NO INTERVENTION

Participants assigned to this arm will receive standard postoperative care following cesarean section under spinal anesthesia, in accordance with routine clinical practice.

Interventions

Coffee ConsumptionDIETARY_SUPPLEMENT

The first coffee (2 g Nescafe Gold™ in 200 ml of hot water) will be given to the participant within the first hour after starting oral feeding. The second coffee will be scheduled according to the participant's surgery time, individual preferences, and sleep patterns, taking into account the 3-9 hour half-life of caffeine. Participants will be given coffee two more times in the following 24-hour period. Thus, participants will consume coffee four times in 48 hours.

Coffee Consumption Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to read, understand, and communicate in Turkish
  • Age ≥ 18 years
  • Undergoing cesarean section under spinal anesthesia
  • Spinal anesthesia administered in the sitting position
  • Initiation of oral intake at postoperative hour 6
  • No history of physiological discomfort related to coffee consumption based on prior experience (e.g., insomnia, palpitations, headache)
  • Ability to understand the study procedures and communicate adequately to provide informed consent

You may not qualify if:

  • Patients undergoing emergency cesarean section
  • Patients with a history of migraine or other types of chronic headache disorders
  • Patients in whom spinal anesthesia was converted to general anesthesia.
  • Patients whose oral intake was postponed for any reason in the postoperative period.
  • Patients with high-risk pregnancies.
  • Use of caffeine-containing analgesic medications during the postoperative period.
  • Postoperative cigarette smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Zeliha Ozdemir Koken

    Hacettepe University Faculty of Nursing

    STUDY CHAIR

Central Study Contacts

Simay Soyer Icbudak, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and investigators will not be blinded. Outcome assessment will be performed by an independent statistician who will be blinded to group allocation through coded group assignments (e.g., Group A and Group B).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups, including an intervention group and a standard care control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the sensitive nature of the data collected in this study.

Locations