Brochure-Supported Telemedicine Management of Postdural Puncture Headache (Brochure-Suppo)

July 15, 2026 updated by: Nureddin YUZKAT, Yuzuncu Yil University

The Effect of Brochure-Supported Structured Telemedicine Counseling on the Management of Postdural Puncture Headache After Cesarean Delivery Under Spinal Anesthesia: A Prospective Randomized Trial

This study evaluates whether brochure-supported structured telemedicine counseling improves the management of postdural puncture headache after cesarean delivery under spinal anesthesia. Participants received either standard information and routine telephone follow-up or structured telephone counseling supported by a visual information brochure. Pain severity, headache duration, adherence to conservative treatment recommendations, and hospital re-presentation were assessed during the first five days after discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postdural puncture headache may occur during the first few days after spinal anesthesia and may become apparent after hospital discharge. During this period, patients need to recognize headache characteristics, follow conservative treatment recommendations, and identify symptoms that require medical evaluation.

This prospective, randomized, open-label study included women aged 18-49 years undergoing elective cesarean delivery under spinal anesthesia. Participants were randomly assigned to one of two parallel groups.

The standard-care group received routine verbal information regarding spinal anesthesia, possible complications, and post-discharge precautions, together with standard telephone follow-up.

The intervention group received the same standard information plus a visual brochure entitled "Five Golden Points After Spinal Anesthesia." The brochure provided information about postdural puncture headache symptoms, positional characteristics, conservative measures that could be used at home, warning symptoms requiring medical attention, and relevant contact information. Structured telemedicine counseling reinforced the brochure content, repeated conservative treatment recommendations, answered patient questions, and provided guidance regarding warning symptoms.

Telephone follow-up was performed on days 1, 2, 3, 4, and 5 after discharge. During follow-up, the presence of postdural puncture headache, pain severity measured using the Numerical Rating Scale, associated symptoms, adherence to conservative treatment recommendations, and hospital re-presentation were evaluated. For participants whose headache continued beyond day 5, total headache duration was recorded until complete symptom resolution.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Van
      • Van, Van, Turkey (Türkiye), 65040
        • Van Yuzuncu Yil University Dursun Odabas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women aged 18-49 years
  • American Society of Anesthesiologists physical status II or III
  • Scheduled for elective cesarean delivery under spinal anesthesia
  • Available for telephone follow-up after hospital discharge
  • Provided written informed consent

Exclusion Criteria:

  • Conversion to or performance of general anesthesia
  • Diagnosis of panic disorder or depression
  • Hypertension
  • Circulatory or coagulation disorders
  • Placental abnormalities
  • Requirement for perioperative blood transfusion
  • Inability to be contacted during the follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard information and standard telephone follow-up
Participants received routine verbal information before and after surgery regarding spinal anesthesia, possible complications, and post-discharge precautions. Standard telephone follow-up was conducted on days 1, 2, 3, 4, and 5 after discharge to assess the presence of postdural puncture headache, pain severity, and adherence to conservative treatment recommendations.
Behavioral: Standard Information and Standard Telephone Follow-up
Routine verbal information regarding spinal anesthesia, possible complications, and post-discharge precautions was provided before and after surgery. Standard telephone follow-up was conducted on days 1 through 5 after discharge to assess postdural puncture headache, pain severity, associated symptoms, and adherence to conservative treatment recommendations.
Experimental: Brochure-Supported Structured Telemedicine Counseling
Participants received routine verbal information and standard follow-up, together with a visual information brochure within the first 12 postoperative hours. Structured telemedicine counseling was provided on days 1, 2, 3, 4, and 5 after discharge to reinforce the brochure content, repeat conservative treatment recommendations, answer patient questions, and provide guidance regarding warning symptoms.
Behavioral: Standard Information and Standard Telephone Follow-up
Routine verbal information regarding spinal anesthesia, possible complications, and post-discharge precautions was provided before and after surgery. Standard telephone follow-up was conducted on days 1 through 5 after discharge to assess postdural puncture headache, pain severity, associated symptoms, and adherence to conservative treatment recommendations.
Behavioral: Brochure-Supported Structured Telemedicine Counseling
A visual information brochure entitled "Five Golden Points After Spinal Anesthesia" was introduced within the first 12 postoperative hours. During structured telephone consultations on days 1 through 5 after discharge, the brochure content was reinforced, conservative treatment recommendations were repeated, patient questions were answered, and guidance regarding warning symptoms and appropriate healthcare use was provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity Among Participants Who Develop Postdural Puncture Headache
Time Frame: 24, 48, 72, 96, and 120 hours after discharge
Pain severity is assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. NRS scores are recorded at each follow-up time point among participants who develop postdural puncture headache. For participants whose headache has resolved, the NRS score is recorded as 0.
24, 48, 72, 96, and 120 hours after discharge
Total Duration of Postdural Puncture Headache
Time Frame: From headache onset until complete symptom resolution, up to 9 days after discharge
Total headache duration is defined as the number of days from the onset of postdural puncture headache until complete symptom resolution among participants who develop postdural puncture headache. If headache persists beyond the fifth follow-up day, duration is determined through additional telephone contact or participant self-report until complete resolution.
From headache onset until complete symptom resolution, up to 9 days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postdural Puncture Headache
Time Frame: Within 5 days after discharge
The number and percentage of randomized participants who develop postdural puncture headache. Postdural puncture headache is defined as a frontal or occipital headache that worsens in the upright position and improves when lying down, in accordance with International Headache Society criteria.
Within 5 days after discharge
Adherence to Conservative Treatment Recommendations
Time Frame: 24, 48, 72, 96, and 120 hours after discharge
The number and percentage of participants who report adherence to the recommended conservative management plan during standardized telephone follow-up. Adherence is assessed separately at each follow-up time point.
24, 48, 72, 96, and 120 hours after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yil University

Collaborators

Yuzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/04-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.

IPD Sharing Time Frame

Data will be available beginning three months after publication and for five years following publication.

IPD Sharing Access Criteria

Data will be shared with qualified researchers who submit a methodologically sound proposal. Requests should be directed to the corresponding author. Access will be subject to institutional and ethical requirements, protection of participant confidentiality, and, where appropriate, completion of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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