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The purpose of the study is to evaluate if maternal anxiety is improved when a parturient gets her choice with regard to the presence of a companion during epidural catheter placement for labor analgesia. It will be focused on parturients having their first child with the current partner. Additionally, it will investigate the effect of ethnicity, health literacy (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the Pain Catastrophizing Scale), and the relationship of the support person to the parturient. The investigators hypothesize that there may be specific subgroups in which maternal anxiety is improved when a parturient gets her choice regarding the presence of a companion during labor epidural catheter placement; however, a significant improvement in maternal anxiety, when including all participants, will not be appreciated.
Parturients who have been admitted to the Labor and Delivery ward at Prentice Women's Hospital will be approached by a member of the anesthesia team prior to the placement of a labor epidural catheter. They will be asked if they are considering neuraxial labor analgesia, and if they are they will be screened using the inclusion and exclusion criteria to determine study eligibility. Once they have been evaluated and found to be appropriate for the study, they will be invited to participate.
Participants will be asked to fill out the STAI questionnaire to assess the level of anxiety prior to placement of the labor epidural catheter, and before knowing their group assignment. They will then complete the pre procedure questionnaire. This questionnaire asks about expectations she has for the labor epidural procedure. They will then be given the page of the Newest Vital Signs questionnaire with the Nutrition Facts, and be asked the 6 questions by the recruiter. Then they will be handed the Pain Catastrophizing Scale form with 13 statements, and asked to fill it out as directed in the instructions at the top. They will then be asked who their primary support person is. A form will be handed to that person to confidentially record if he/she would prefer to be present for the procedure. This form will be collected from the companion, and without the parturient aware of the support person's response, she will be asked for her preference with regard to the presence of a companion in the room, which will be recorded on this form as well. Finally, she will be asked which ethnicity she most relates to, also to be recorded on this form.
After all these data have been collected, the parturient will be randomized as to whether her companion will be allowed in the room or will be asked to leave. This will not be communicated to the parturient until the time of the labor epidural catheter placement. When she requests the neuraxial labor analgesia, the provider placing the labor epidural catheter will be made aware of which group she has been randomized to, and will either ask the companion to leave for placement, or provide the support person a non-mobile chair to sit on in front of the parturient for placement of the labor epidural. The companion will be asked to remain in the chair. He/she will be asked to focus on the parturient. It will be emphasized that he/she must remain seated and will not be allowed to observe the procedure being performed. This is to prevent loss of consciousness in the support person, which has been documented in the literature (Devore and Asrani, 1978; Crosby and Halpern, 1989). One violation will result in a warning, and after a second the companion will be escorted out of the room and the participant will be removed from the study.
The provider will place the labor epidural catheter in the regular fashion, as is common practice at Prentice Women's Hospital. After preparation and draping of the skin in the sitting position, infiltration with Lidocaine 1% will be conducted at L3-L4 or L4-L5. A 17g Tuohy needle will be advanced into the epidural space, using a loss of resistance with either saline or air, depending on the provider's preference. After the epidural space has been located, a 27g pencil-tip spinal needle will be placed through the Tuohy, into the intrathecal space, and an intrathecal dose of medication will be administered. The exact dose to be injected will be left up to the discretion of the provider, who will determine the appropriate dose based on the patient's situation at that time. After the intrathecal dose is administered, the spinal needle will be removed and a 19g epidural catheter will be placed through the Tuohy into the epidural space. It will be secured at the skin with a sterile dressing and tape, leaving 5cm of the catheter in the epidural space. The patient will then be placed in a lateral position.
After the completion of the neuraxial procedure, the study participant will then be asked to fill out the STAI questionnaire again. Additionally, she will be asked to record her perception of pain during the placement of the labor epidural catheter, using a VAS (Visual Analogue Scale) from 0-100mm. At that point the parturient's participation in the study will be complete.
The provider placing the labor epidural catheter will be asked to evaluate his/her ability to palpate landmarks for placement, the positioning of the patient, and overall perceived difficulty with the epidural placement, using a VAS from 0-100mm for each, which will be kept confidential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No companion present | No Intervention | No companion is present during the placement of the epidural catheter. | |
| Companion present | Active Comparator | A companion will be present during the placement of the epidural catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Companion Present | Other | A companion will be present during the epidural catheter placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. | The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied | Average 12 hours, up to 24 hours after epidural placement |
| Measure | Description | Time Frame |
|---|---|---|
| Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire. | Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group. |
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Inclusion Criteria:
Physician Inclusion:
Companion Inclusion:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feyce Peralta, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Companion Present | No companion is present during the placement of the epidural catheter. |
| FG001 | Companion Present | A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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In the companion not in the room group, 73 subjects received the intervention and 70 completed follow up.
In the companion in the room group, 75 completed demographic data, 73 subjects received intervention and 74 completed follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Companion Present | No companion is present during the placement of the epidural catheter. |
| BG001 | Companion Present | A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. | The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied | Posted | Count of Participants | Participants | Average 12 hours, up to 24 hours after epidural placement |
|
24 hours after delivery of the baby.
Emotional distress answering some of the questionnaires as reported by the subject to the study team members.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Companion | No companion in the room during the procedure | 0 |
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The limitation is our sample was primarily Caucasian with mid to high socioeconomic status. Additionally, most of the companions were married to the study participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Feyce Peralta, MD | Northwestern University | 312-472-3585 | feyce.peralta@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2016 | Jul 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 hours after epidural placement |
| Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter. | Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable). | After epidural placement |
| What is the Preference of Subjects to Have a Companion Present for Future Procedures. | What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely. | 24 hours after epidural placement |
| Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. | Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely. | 24 hours after epidural |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Gestational Age | In the companion not in the room group 72 completed gestational data and in the companion group 73 completed the gestational data. . | Mean | Full Range | Weeks |
|
| NRS pain score | Numerical Rating Scale (NRS) pain score (0 no pain to 10 worst pain imaginable) at request for neuraxial analgesia | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery | Mean | Full Range | units on a scale |
|
| Cervical Dilation | Cervical dilation in centimeters. | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed . | Mean | Full Range | centimeters |
|
| Labor Type | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Count of Participants | Participants |
|
| Labor epidural procedural expectations | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Count of Participants | Participants |
|
| Greatest concern regarding epidural procedure | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section). | Count of Participants | Participants |
|
| Have you spoken to friends or family about labor epidurals? | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Count of Participants | Participants |
|
| Researched epidurals through social media? | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Count of Participants | Participants |
|
| Relationship of primary companion | Count of Participants | Participants |
|
| How long have you known your companion (years)? | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Mean | Full Range | Years |
|
| Work in medical field? | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Count of Participants | Participants |
|
| Preprocedure pain catastrophizing scale | The PCS is a self reported 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is contains three subscales being magnification, rumination, and helplessness. Possible score is 0-52 where the higher scores indicate that the more catastrophizing thoughts are present. Catastrophizing thinking can result in a more intense experience of pain. | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Median | Inter-Quartile Range | units on a scale |
|
| Newest vital sign | The Newest Vital Sign (NVS), is a nutrition label is accompanied by 6 questions. Answering more than 4 correct responses are unlikely to have low literacy, whereas answering fewer than 4 correct answers indicate the possibility of limited literacy. Possible score 0 low health literacy-6 high health literacy. | 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Count of Participants | Participants |
|
| State-Trait (STAI) Anxiety Inventory | The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. | 73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery) | Mean | Full Range | Score on a scale |
|
| Labor Epidural Performance: Trainee Level | Physician training level of the operator of the epidural placement catheter. | Training level of operator for the epidural catheter placement CA1-CA3 = clinical anesthesiology training year. 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Count of Participants | Participants |
|
| Number of Participants Categorized by Number of Epidural Catheter Attempts | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Count of Participants | Participants |
|
| Number of Attending Anesthesiologist Takeover of Epidural Placement | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Number | Attending Takeovers |
|
| Resident Assessment of Difficulty of Epidural Procedure | Difficulty of procedure scored on a scale of 0 (extremely difficult) to 100 (not difficult). | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Median | Inter-Quartile Range | Score on a scale |
|
| Resident Assessment of Ability to Position Patient (0-100) | The operator (resident) assessment of the difficulty of preparing the patient for positioning prior to the epidural catheter placement scored on a scale of 0 (difficult) to 100 (easy). | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up) and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Median | Inter-Quartile Range | units on a scale |
|
| Resident Assessment of Ability to Palpate Landmarks | Operator (resident) assessment of ability to palpate landmarks prior to epidural placement procedure on a scale of 0 extremely difficult to 100 not difficult. | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Median | Inter-Quartile Range | units on a scale |
|
| Resident Comfort Performing Procedure (0-10) | Operator (resident) comfort performing the epidural placement procedure on a scale of 0 (severe discomfort) to 10 being (extremely comfortable). | 70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery). | Median | Inter-Quartile Range | units on a scale |
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| Secondary | Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire. | Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group. | Posted | Median | Inter-Quartile Range | score on scale | 24 hours after epidural placement |
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| Secondary | Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter. | Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable). | Posted | Median | Inter-Quartile Range | score on scale | After epidural placement |
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| Secondary | What is the Preference of Subjects to Have a Companion Present for Future Procedures. | What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely. | Posted | Count of Participants | Participants | 24 hours after epidural placement |
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| Secondary | Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. | Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely. | Posted | Count of Participants | Participants | 24 hours after epidural |
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| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Companion Present | Companion present during the procedure | 0 | 75 | 0 | 75 | 0 | 75 |
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| Neutral |
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| Unlikely |
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| Highly unlikely |
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| Did not respond |
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| Neutral |
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| Unlikely |
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| Highly unlikely |
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| Did not respond |
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