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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain Severity Among Participants Who Develop Postdural Puncture Headache
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Standard Information and Standard Telephone Follow-up (Behavioral)
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.
干预措施: Standard Information and Standard Telephone Follow-up (Behavioral)
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.
干预措施: Brochure-Supported Structured Telemedicine Counseling (Behavioral)
结局指标
主要结局
Pain Severity Among Participants Who Develop Postdural Puncture Headache
时间窗: 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
时间窗: 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.
次要结局
- Incidence of Postdural Puncture Headache(Within 5 days after discharge)
- Adherence to Conservative Treatment Recommendations(24, 48, 72, 96, and 120 hours after discharge)
研究者
Nureddin YUZKAT
Principal Investigator, Department of Anesthesiology and Reanimation, Van Yüzüncü Yıl University
Yuzuncu Yil University