Cesarean Delivery Procedures, Postdural Puncture Headache (PDPH), Treatment Adherence and Compliance
Conditions
Keywords
Telemedicine, Patient Education, Cesarean Delivery, Spinal Anesthesia, Treatment Adherence, Postpartum Follow-up
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.
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALBrochure-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.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity Among Participants Who Develop Postdural Puncture Headache | 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. |
| Total Duration of Postdural Puncture Headache | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postdural Puncture Headache | 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. |
| Adherence to Conservative Treatment Recommendations | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed