Informed Consent in NeurosurgeryNCT07064252
Educational Informed Consent Video in Neurosurgery
A study testing Educational Informed Consent Video and Standard informed consent in people with Informed Consent in Neurosurgery, run by Felix C. Stengel, MD at 1 site in Switzerland.
Trial summary
This single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Informed Consent in Neurosurgery
- What is being tested?
- Educational Informed Consent Video and Standard informed consent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to 1 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population comprises adult patients scheduled for elective neurosurgical intracranial tumor resection
Who cannot join
- Patients requiring emergency surgery
- Patients with cognitive impairments preventing informed consent
- Patients with significant language barriers impeding effective communication
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurosurgery, HOCH Health Ostschweiz, Kantonsspital St. Gallen, St.Gallen, Switzerland
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: Educational Informed Consent Video in Neurosurgery: A Randomized Controlled Trial
This single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures.
Read the detailed description
Importance: Informed consent in neurosurgery faces unique challenges due to procedural complexity and limited clinical time, with traditional methods often resulting in suboptimal patient comprehension.
Objective: To determine whether preoperative educational videos improve patient comprehension and satisfaction compared to standard consent procedures in neurosurgical patients.
Design: Single-center, non-blinded randomized controlled trial. Patients are randomized (1:1) using opaque envelope methods.
Setting: Department of Neurosurgery, Kantonsspital St. Gallen, Switzerland. Intervention: Video group receives individualized educational videos plus standard consent. Control group receives standard consent only. Videos coveres surgical indication, anatomy, procedural details, and risks.
Main Outcomes and Measures: Primary outcomes: patient comprehension via standardized questionnaires, satisfaction with consent process, psychological distress (Patient Health Questionnaire-4). Assessments conducted preoperatively and postoperatively.
- Conditions
- Informed Consent in Neurosurgery
- Being tested
- Educational Informed Consent Video, Standard informed consent
- Keywords
- Informed consent, neurosurgery, Randomized controlled trial, video-assisted consent, Patient satisfaction, Patient comprehension
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Informed Consent VideoProcedure or surgery
Individualized procedure-specific educational video. Videos are developed by a multidisciplinary collaboration of neurosurgeons, medical educators, and patient advocates. Each video is tailored based on location of the pathology, surgical approach, positioning, anticoagulation intake, and intraoperative adjuncts such as electrophysiology. Each video followes a standardized format covering anatomical considerations, preoperative care, the surgical procedure, and postoperative care including potential complications, expected recovery process, and post-surgery instructions.
Standard informed consentProcedure or surgery
Standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable
| Study group | Role | What they receive |
|---|---|---|
| Video Group | Experimental | Video group receives standard informed consent plus an individualized procedure-specific educational video Receives: Procedure: Educational Informed Consent Video; Procedure: Standard informed consent |
| Control Group | Active comparator | Control group receives standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable Receives: Procedure: Standard informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Comprehension
The investigators assess patients' comprehension through standardized questionnaires developed for neurosurgical procedures. Comprehension is evaluated by dichotomized responses: patients answering all questions correctly versus those who did not.
Measured: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Patient Satisfaction
The investigators assess patients' satisfaction through standardized questionnaires developed for neurosurgical procedures. To measure satisfaction with consent and information delivery we use a visual analogue scale (0-100, higher scores indicating greater satisfaction).
Measured: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Psychological Distress
The investigators evaluate psychological distress using the Patient Health Questionnaire 4 (PHQ-4).
The PHQ-4 (Patient Health Questionnaire-4) is a brief, self-administered questionnaire used to screen for both anxiety and depression. It combines the PHQ-2 (a 2-item depression screener) and the GAD-2 (a 2-item anxiety screener). The PHQ-4 is designed to be a quick and easy way to identify individuals who may be experiencing symptoms of anxiety or depression, prompting further evaluation if needed. Scoring: Each item is scored on a 4-point Likert scale (0-3), and the scores are summed for each subscale (GAD-2 and PHQ-2) and the overall PHQ-4.
Measured: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Secondary outcomes (1)
Satisfaction with hospital stay
We measure satisfaction with the hospital stay and information delivery using a visual analogue scale (0-100, higher scores indicating greater satisfaction)
Measured: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Mar 2022
- Primary completion31 Aug 2023
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed Consent in NeurosurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felix C. Stengel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor-investigator, Felix C. Stengel, MD, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064252
- Sponsor's protocol ID
- 2022-0000687
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Informed Consent Video in Neurosurgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07064252
- Acronym / sponsor ID
- 2022-0000687
- Conditions
- Informed Consent in Neurosurgery
- Keywords
- Informed consent, neurosurgery, Randomized controlled trial, video-assisted consent, Patient satisfaction, Patient comprehension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Felix C. Stengel, MDUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 Jul 2025 (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 single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures.
Detailed description
Importance: Informed consent in neurosurgery faces unique challenges due to procedural complexity and limited clinical time, with traditional methods often resulting in suboptimal patient comprehension.
Objective: To determine whether preoperative educational videos improve patient comprehension and satisfaction compared to standard consent procedures in neurosurgical patients.
Design: Single-center, non-blinded randomized controlled trial. Patients are randomized (1:1) using opaque envelope methods.
Setting: Department of Neurosurgery, Kantonsspital St. Gallen, Switzerland. Intervention: Video group receives individualized educational videos plus standard consent. Control group receives standard consent only. Videos coveres surgical indication, anatomy, procedural details, and risks.
Main Outcomes and Measures: Primary outcomes: patient comprehension via standardized questionnaires, satisfaction with consent process, psychological distress (Patient Health Questionnaire-4). Assessments conducted preoperatively and postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Group | Experimental | Procedure: Educational Informed Consent Video, Procedure: Standard informed consentVideo group receives standard informed consent plus an individualized procedure-specific educational video |
| Control Group | Active comparator | Procedure: Standard informed consentControl group receives standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population comprises adult patients scheduled for elective neurosurgical intracranial tumor resection
Key exclusion criteria (3 listed)
- Patients requiring emergency surgery
- Patients with cognitive impairments preventing informed consent
- Patients with significant language barriers impeding effective communication
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 |
|---|---|---|
| Educational Informed Consent VideoIndividualized procedure-specific educational video. Videos are developed by a multidisciplinary collaboration of neurosurgeons, medical educators, and patient advocates. Each video is tailored based on location of the pathology, surgical approach, positioning, anticoagulation intake, and intraoperative adjuncts such as electrophysiology. Each video followes a standardized format covering anatomical considerations, preoperative care, the surgical procedure, and postoperative care including potential complications, expected recovery process, and post-surgery instructions. | Procedure or surgery | Video Group |
| Standard informed consentStandard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable | Procedure or surgery | Control Group, Video Group |
Primary outcome
Patient Comprehension
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators assess patients' comprehension through standardized questionnaires developed for neurosurgical procedures. Comprehension is evaluated by dichotomized responses: patients answering all questions correctly versus those who did not.
Patient Satisfaction
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators assess patients' satisfaction through standardized questionnaires developed for neurosurgical procedures. To measure satisfaction with consent and information delivery we use a visual analogue scale (0-100, higher scores indicating greater satisfaction).
Psychological Distress
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators evaluate psychological distress using the Patient Health Questionnaire 4 (PHQ-4). The PHQ-4 (Patient Health Questionnaire-4) is a brief, self-administered questionnaire used to screen for both anxiety and depression. It combines the PHQ-2 (a 2-item depression screener) and the GAD-2 (a 2-item anxiety screener). The PHQ-4 is designed to be a quick and easy way to identify individuals who may be experiencing symptoms of anxiety or depression, prompting further evaluation if needed. Scoring: Each item is scored on a 4-point Likert scale (0-3), and the scores are summed for each subscale (GAD-2 and PHQ-2) and the overall PHQ-4.
1 secondary outcome
Satisfaction with hospital stay
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
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 14 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Informed Consent in Neurosurgery
RecruitingObservational study
VR in Neurosurgery: Planning, Training & Communication
Brain Pathology
Recruiting
Virtual Reality for Patient Informed Consent in Neurosurgery
VR-based Informed Consent
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 Educational Informed Consent Video and Standard informed consent in people with Informed Consent in Neurosurgery, run by Felix C. Stengel, MD at 1 site in Switzerland.
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 1 inclusion and 3 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 14 Jul 2025. 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 Switzerland. 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?
Patient Comprehension (time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.