Presence of a Companion During Performance of Neuraxial Labor Analgesia

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.

Inclusion Criteria:

- Delivering the first child

- Planning to labor with neuraxial analgesia.

- Additionally, there will need to be sufficient time before delivery to allow the
completion of the Pre procedure questionnaire, State-Trait Anxiety Inventory (STAI)
questionnaire both before and after the procedure, as well as the Newest Vital Sign
questionnaire and the Pain Catastrophizing Scale questionnaire before the procedure.

- They will be included if they are ASA (American Society of Anesthesiologists) 2.

- Able to read and comprehend the English language, as the Newest Vital Sign
questionnaire requires them to read and interpret a nutrition label.

Physician Inclusion:

- Anesthesiology Attending Physician, fellow or resident who participants in the
placement of the epidural catheter placement

Companion Inclusion:

- Primary companion identified by parturient over the age of 18

Exclusion Criteria:

- Parturients will be excluded if they are receiving neuraxial anesthesia for a
cesarean delivery,

- External cephalic version

- Non-labor procedure.

- Subjects will be excluded if they begin to push for delivery before completion of the
STAI questionnaire following labor epidural catheter placement.

- They will be excluded if there is no support person present at the time of the
neuraxial procedure.

- They will be excluded if they are ASA 3 or greater, or if they have a
contraindication to receiving any of the medications routinely used in the placement
of a labor epidural catheter (lidocaine, bupivacaine, epinephrine, fentanyl).

- Adults who are unable to consent and minors will be excluded.