Patient SatisfactionNCT02472327
Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections
A study testing Pre-operative support in people with Patient Satisfaction and Cesarean Section, run by Albany Medical College at 1 site in United States.
Trial summary
Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Patient Satisfaction, Cesarean Section
- What is being tested?
- Pre-operative support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant patient admitted at Albany Medical Center
- Faculty group patient
Who cannot join
- --Patients who have scheduled cesarean sections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections: A Prospective Trial
Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the situation. The purpose of this second phase of this study is to try and improve patient dissatisfaction by offering additional emotional support prior to the c/s with the hope of decreasing the trust issues toward physicians, decreasing the communication barriers, and decreasing the fear and loss of control. The additional emotional support that will be received prior to the cesarean section will be scripted based upon the findings of the investigators' prior study - the patient will be asked four questions and each question addresses the four themes that were noted in the previous study.
Read the detailed description
All patients admitted to the Labor and Delivery unit at Albany Medical College who are in labor or being evaluated for possible indicated delivery will receive information regarding the study. Those who consent to participation, if they are then determined to need a cesarean birth will be randomized into two groups. The first group will receive pre-operative counseling by the obstetrics resident who will be performing the cesarean, the second group will receive usual care. The counseling sheet was determined based upon the findings of a previous study done at this institution, and addresses four themes that were recurrent aspects of patient dissatisfaction after cesarean birth: poor communication, trust of physicians, loss of control, and fear of surgery.
Two weeks after the cesarean section, patients participating in the study are called on the phone by one of the investigators. A patient satisfaction survey, using a Likert scale is administered. This investigator is blinded as to whether the patient has received the additional counseling or not. Comparison of these scores will be used to determine whether pre-operative counseling can reduce dissatisfaction in patients undergoing unplanned cesarean sections.
- Conditions
- Patient Satisfaction, Cesarean Section
- Being tested
- Pre-operative support
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Typical Care | No intervention | These patients will receive normal peripartum care and support. |
| Pre-operative support | Experimental | These patients will receive additional emotional support prior to undergoing an unplanned cesarean section during labor. Receives: Behavioral: Pre-operative support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Two weeks postpartum study subjects will participate in a patient satisfaction survey, using a phone interview, and a quantitative Likert scale to determine whether pre-operative counseling improves patient satisfaction scores.
Measured: 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Burcher Md, PhD, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472327
- Sponsor's protocol ID
- AlbanyMC
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Patient Dissatisfaction With Unplanned Cesarean Sections: A Prospective Trial
- ClinicalTrials.gov ID
- NCT02472327
- Acronym / sponsor ID
- AlbanyMC
- Conditions
- Patient Satisfaction, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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.
Patient satisfaction after an unplanned cesarean section was studied and in the previous study it was noted that there were common themes that lead to patient dissatisfaction. The four common themes were: lack of trust regarding the indications for surgery, communication issues, loss of control, and fear during the situation. The purpose of this second phase of this study is to try and improve patient dissatisfaction by offering additional emotional support prior to the c/s with the hope of decreasing the trust issues toward physicians, decreasing the communication barriers, and decreasing the fear and loss of control. The additional emotional support that will be received prior to the cesarean section will be scripted based upon the findings of the investigators' prior study - the patient will be asked four questions and each question addresses the four themes that were noted in the previous study.
Detailed description
All patients admitted to the Labor and Delivery unit at Albany Medical College who are in labor or being evaluated for possible indicated delivery will receive information regarding the study. Those who consent to participation, if they are then determined to need a cesarean birth will be randomized into two groups. The first group will receive pre-operative counseling by the obstetrics resident who will be performing the cesarean, the second group will receive usual care. The counseling sheet was determined based upon the findings of a previous study done at this institution, and addresses four themes that were recurrent aspects of patient dissatisfaction after cesarean birth: poor communication, trust of physicians, loss of control, and fear of surgery.
Two weeks after the cesarean section, patients participating in the study are called on the phone by one of the investigators. A patient satisfaction survey, using a Likert scale is administered. This investigator is blinded as to whether the patient has received the additional counseling or not. Comparison of these scores will be used to determine whether pre-operative counseling can reduce dissatisfaction in patients undergoing unplanned cesarean sections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Care | No intervention | –These patients will receive normal peripartum care and support. |
| Pre-operative support | Experimental | Behavioral: Pre-operative supportThese patients will receive additional emotional support prior to undergoing an unplanned cesarean section during labor. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pregnant patient admitted at Albany Medical Center
- Faculty group patient
Key exclusion criteria (1 listed)
- --Patients who have scheduled cesarean sections
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 |
|---|---|---|
| Pre-operative support | Behavioural | Pre-operative support |
Primary outcome
Patient satisfaction
Time frame: 2 weeks postpartum
Two weeks postpartum study subjects will participate in a patient satisfaction survey, using a phone interview, and a quantitative Likert scale to determine whether pre-operative counseling improves patient satisfaction scores.
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 12 Jan 2018.
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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 Pre-operative support in people with Patient Satisfaction and Cesarean Section, run by Albany Medical College 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 2 inclusion and 1 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 12 Jan 2018. 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?
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 satisfaction (time frame: 2 weeks postpartum). 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 12 Jan 2018; AzTrials last refreshed its copy on 2 Nov 2026.