Brochure-Supported Telemedicine Management of Postdural Puncture Headache

NCT07708701 | Completed

• 1 other identifier: 2025/04-03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postdural Puncture Headache (PDPH); Treatment Adherence and Compliance; Cesarean Delivery Procedures

Keywords

Telemedicine; Patient Education; Cesarean Delivery; Spinal Anesthesia; Treatment Adherence; Postpartum Follow-up

Outcome Measures

Primary Outcomes (2)

• Pain Severity Among Participants Who Develop Postdural Puncture Headache

  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

  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 Outcomes (2)

• Incidence of Postdural Puncture Headache

  Within 5 days after discharge

• Adherence to Conservative Treatment Recommendations

  24, 48, 72, 96, and 120 hours after discharge

Study Arms (2)

Standard information and standard telephone follow-up

ACTIVE COMPARATOR

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

Brochure-Supported Structured Telemedicine Counseling

EXPERIMENTAL

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; Behavioral: Brochure-Supported Structured Telemedicine Counseling

Interventions

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; Standard information and standard telephone follow-up

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.

Brochure-Supported Structured Telemedicine Counseling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Dursun Odabas Medical Center

Van, Van, 65040, Turkey (Türkiye)

Location

Related Publications (3)

• Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.

  PMID: 27016900 BACKGROUND

• Patel R, Urits I, Orhurhu V, Orhurhu MS, Peck J, Ohuabunwa E, Sikorski A, Mehrabani A, Manchikanti L, Kaye AD, Kaye RJ, Helmstetter JA, Viswanath O. A Comprehensive Update on the Treatment and Management of Postdural Puncture Headache. Curr Pain Headache Rep. 2020 Apr 22;24(6):24. doi: 10.1007/s11916-020-00860-0.

  PMID: 32323013 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 209: Obstetric Analgesia and Anesthesia. Obstet Gynecol. 2019 Mar;133(3):e208-e225. doi: 10.1097/AOG.0000000000003132.

  PMID: 30801474 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Reanimation, Van Yüzüncü Yıl University

Model Details: Participants were randomly assigned in a 1:1 ratio to two parallel groups. The control group received standard verbal information and standard telephone follow-up, whereas the intervention group received brochure-supported structured telemedicine counseling in addition to standard information. Participants remained in their assigned groups throughout the five-day post-discharge follow-up period.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning three months after publication and for five years following publication.
• 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.

Locations

TU (1)