PregnancyNCT06945250
A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
A study testing Experimental Audio Visual in people with Pregnancy and Caesarean Section, run by Northwestern University at 1 site in United States.
Trial summary
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Caesarean Section
- What is being tested?
- Experimental Audio Visual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over on the day of the procedure
- Able to provide verbal and written informed consent for participation in the study
- Primarily English-speaking patients (the audiovisual presentation will be available only in English
Who cannot join
- Refusal or inability to participate or provide informed consent
- Primarily non-English speaking patients
- At the discretion of the attending anesthesiologist of record due to medical complexity
Trial locations and contacts
1 site in 1 country.
About this study
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention.
The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist.
The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.
- Conditions
- Pregnancy, Caesarean Section
- Being tested
- Experimental Audio Visual
- Keywords
- Pregnancy, Cesarean Section, Consent Process, Surgical Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Audio VisualOther
Participants in this group will receive the audiovisual presentation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention Group: Participants randomized to the intervention group will receive a link to the audiovisual presentation via e-mail to review prior to coming into the hospital for caesarean section. Receives: Other: Experimental Audio Visual |
| Control Group | No intervention | Control Group: Participants randomized to the control group will not receive the link to the audiovisual presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMRADE survey score
COMRADE score for risk communication and treatment decision making on a 100-point scale, ranging from 0 (decision-making not informed at all (poor)) to 100 (most informed decision possible (good))
Measured: 1 Day after delivery of baby
Secondary outcomes (4)
Demographic factors associated with increase in informed decision-making
Demographic factors associated with increase in informed decision-making including age, education level, history of prior Caesarean delivery, history of other anesthetics (such as labor epidurals or general anesthetics)
Measured: 1 Day after delivery of baby
Level of subjective anxiety associated with the proposed anesthetic
Level of subjective anxiety associated with the proposed anesthetic based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
Measured: 1 Day after delivery of baby
Level of subjective fear associated with the proposed anesthetic
Level of subjective fear associated with the proposed anesthetic measured on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree)
Measured: 1 Day after delivery of baby
Level of satisfaction with the anesthetic informed consent process
Level of satisfaction with the anesthetic informed consent process based on a scale of 1-5 (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, (5) strongly agree).
Measured: 1 Day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start6 Jun 2025
- Primary completion22 May 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleanor Kenny, Northwestern University
- Investigators
- Eleanor Kenny, MD, Principal investigator, Northwestern Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945250
- Sponsor's protocol ID
- STU00222960
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
PubMed 12900105Cassady JF Jr, Wysocki TT, Miller KM, Cancel DD, Izenberg N. Use of a preanesthetic video for facilitation of parental education and anxiolysis before pediatric ambulatory surgery. Anesth Analg. 1999 Feb;88(2):246-50. doi: 10.1097/00000539-199902000-00004.
PubMed 9972735Wisselo TL, Stuart C, Muris P. Providing parents with information before anaesthesia: what do they really want to know? Paediatr Anaesth. 2004 Apr;14(4):299-307. doi: 10.1046/j.1460-9592.2003.01222.x.
PubMed 15078374Atsaidis Z, Antel R, Guadagno E, Wiseman J, Poenaru D. Understanding the effectiveness of consent processes and conversations in pediatric surgery: A systematic-scoping review. J Pediatr Surg. 2022 Dec;57(12):834-844. doi: 10.1016/j.jpedsurg.2022.08.004. Epub 2022 Aug 11.
PubMed 36031429Garden AL, Merry AF, Holland RL, Petrie KJ. Anaesthesia information--what patients want to know. Anaesth Intensive Care. 1996 Oct;24(5):594-8. doi: 10.1177/0310057X9602400516.
PubMed 8909673Jawaid M, Farhan M, Masood Z, Husnain S. Preoperative informed consent: is it truly informed? Iran J Public Health. 2012;41(9):25-30. Epub 2012 Sep 1.
PubMed 23193502Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5.
PubMed 24898765
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
- ClinicalTrials.gov ID
- NCT06945250
- Acronym / sponsor ID
- STU00222960
- Conditions
- Pregnancy, Caesarean Section
- Keywords
- Pregnancy, Cesarean Section, Consent Process, Surgical Procedure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Apr 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.
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention.
The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist.
The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Experimental Audio VisualIntervention Group: Participants randomized to the intervention group will receive a link to the audiovisual presentation via e-mail to review prior to coming into the hospital for caesarean section. |
| Control Group | No intervention | –Control Group: Participants randomized to the control group will not receive the link to the audiovisual presentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over on the day of the procedure
- Able to provide verbal and written informed consent for participation in the study
- Primarily English-speaking patients (the audiovisual presentation will be available only in English
Key exclusion criteria (3 listed)
- Refusal or inability to participate or provide informed consent
- Primarily non-English speaking patients
- At the discretion of the attending anesthesiologist of record due to medical complexity
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 |
|---|---|---|
| Experimental Audio VisualParticipants in this group will receive the audiovisual presentation | Other | Intervention Group |
Primary outcome
COMRADE survey score
Time frame: 1 Day after delivery of baby
COMRADE score for risk communication and treatment decision making on a 100-point scale, ranging from 0 (decision-making not informed at all (poor)) to 100 (most informed decision possible (good))
4 secondary outcomes
Demographic factors associated with increase in informed decision-making
Time frame: 1 Day after delivery of baby
Level of subjective anxiety associated with the proposed anesthetic
Time frame: 1 Day after delivery of baby
Level of subjective fear associated with the proposed anesthetic
Time frame: 1 Day after delivery of baby
Level of satisfaction with the anesthetic informed consent process
Time frame: 1 Day after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 12900105Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
- Background: PubMed 9972735Cassady JF Jr, Wysocki TT, Miller KM, Cancel DD, Izenberg N. Use of a preanesthetic video for facilitation of parental education and anxiolysis before pediatric ambulatory surgery. Anesth Analg. 1999 Feb;88(2):246-50. doi: 10.1097/00000539-199902000-00004.
- Background: PubMed 15078374Wisselo TL, Stuart C, Muris P. Providing parents with information before anaesthesia: what do they really want to know? Paediatr Anaesth. 2004 Apr;14(4):299-307. doi: 10.1046/j.1460-9592.2003.01222.x.
- Background: PubMed 36031429Atsaidis Z, Antel R, Guadagno E, Wiseman J, Poenaru D. Understanding the effectiveness of consent processes and conversations in pediatric surgery: A systematic-scoping review. J Pediatr Surg. 2022 Dec;57(12):834-844. doi: 10.1016/j.jpedsurg.2022.08.004. Epub 2022 Aug 11.
- Background: PubMed 8909673Garden AL, Merry AF, Holland RL, Petrie KJ. Anaesthesia information--what patients want to know. Anaesth Intensive Care. 1996 Oct;24(5):594-8. doi: 10.1177/0310057X9602400516.
- Background: PubMed 23193502Jawaid M, Farhan M, Masood Z, Husnain S. Preoperative informed consent: is it truly informed? Iran J Public Health. 2012;41(9):25-30. Epub 2012 Sep 1.
- Background: PubMed 24898765Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5.
- Individual participant dataSharing planned: No
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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.
Eleanor Kenny, MD principal investigator
Northwestern Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Audio Visual in people with Pregnancy and Caesarean Section, run by Northwestern University at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
COMRADE survey score (time frame: 1 Day after delivery of baby). 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 NCT06945250, which also lists 7 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 Aug 2026.