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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postdural Puncture Headache | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University Dursun Odabas Medical Center | Van | Van | 65040 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27016900 | Background | 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. | |
| 32323013 | Background |
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De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
Data will be available beginning three months after publication and for five years following publication.
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.
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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.
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| 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. |
|
| Adherence to Conservative Treatment Recommendations | 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 |
| 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. |
| 30801474 | 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. |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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