Postdural Puncture Headache (PDPH)Brochure-SuppoNCT07708701
Brochure-Supported Telemedicine Management of Postdural Puncture Headache
A study testing Standard Information and Standard Telephone Follow-up and Brochure-Supported Structured Telemedicine Counseling in people with Postdural Puncture Headache (PDPH) and Treatment Adherence and Compliance, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether brochure-supported structured telemedicine counseling improves the management of postdural puncture headache after cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Postdural Puncture Headache (PDPH), Treatment Adherence and Compliance, Cesarean Delivery Procedures
- What is being tested?
- Standard Information and Standard Telephone Follow-up and Brochure-Supported Structured Telemedicine Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Dursun Odabas Medical Center
Van, Van, 65040
About this study
Official 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
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.
Read the 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.
- Conditions
- Postdural Puncture Headache (PDPH), Treatment Adherence and Compliance, Cesarean Delivery Procedures
- Being tested
- Standard Information and Standard Telephone Follow-up, Brochure-Supported Structured Telemedicine Counseling
- Keywords
- Telemedicine, Patient Education, Cesarean Delivery, Spinal Anesthesia, Treatment Adherence, Postpartum Follow-up
- Medical subject headings
- Post-Dural Puncture Headache, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Information and Standard Telephone Follow-upBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Information and Standard Telephone Follow-up; Behavioral: Brochure-Supported Structured Telemedicine Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From headache onset until complete symptom resolution, up to 9 days after discharge
Secondary outcomes (2)
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.
Measured: Within 5 days after discharge
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.
Measured: 24, 48, 72, 96, and 120 hours after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 May 2025
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture Headache (PDPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708701
- Sponsor's protocol ID
- 2025/04-03
- Acronym
- Brochure-Suppo
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
Publications
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.
PubMed 27016900Patel 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.
PubMed 32323013American 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.
PubMed 30801474
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07708701
- Acronym / sponsor ID
- Brochure-Suppo / 2025/04-03
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard information and standard telephone follow-up | Active comparator | Behavioral: Standard Information and Standard Telephone Follow-upParticipants 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. |
| Brochure-Supported Structured Telemedicine Counseling | Experimental | Behavioral: Standard Information and Standard Telephone Follow-up, Behavioral: Brochure-Supported Structured Telemedicine CounselingParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Conversion to or performance of general anesthesia
- Diagnosis of panic disorder or depression
- Hypertension
- Circulatory or coagulation disorders
- Placental abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Information and Standard Telephone Follow-upRoutine 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. | Behavioural | Brochure-Supported Structured Telemedicine Counseling, Standard information and standard telephone follow-up |
| Brochure-Supported Structured Telemedicine CounselingA 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. | Behavioural | Brochure-Supported Structured Telemedicine Counseling |
Primary outcome
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.
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.
2 secondary outcomes
Incidence of Postdural Puncture Headache
Time frame: Within 5 days after discharge
Adherence to Conservative Treatment Recommendations
Time frame: 24, 48, 72, 96, and 120 hours after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 27016900Gunter 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.
- Background: PubMed 32323013Patel 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.
- Background: PubMed 30801474American 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Information and Standard Telephone Follow-up and Brochure-Supported Structured Telemedicine Counseling in people with Postdural Puncture Headache (PDPH) and Treatment Adherence and Compliance, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity Among Participants Who Develop Postdural Puncture Headache (time frame: 24, 48, 72, 96, and 120 hours after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07708701, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.