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NCT Number: NCT07708701

Brochure-Supported Telemedicine Management of Postdural Puncture Headache

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.

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Key information

Conditions

Postdural Puncture Headache (PDPH) Behavior Brain Diseases Central Nervous System Diseases Cesarean Delivery Procedures Headache Disorders Headache Disorders, Secondary Health Behavior Nervous System Diseases Post-Dural Puncture Headache Treatment Adherence and Compliance

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University Dursun Odabas Medical Center

Van, 65040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Information and Standard Telephone Follow-up

Behavioral

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.

Brochure-Supported Structured Telemedicine Counseling

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Acronym: Brochure-Suppo

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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