Clinical trial NCT02982213: Presence of a Companion During Performance of Neuraxial Labor Analgesia
Official title: Presence of a Companion During Performance of Neuraxial Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Health Knowledge, Attitudes, Practice
Keywords: Newest Vital Sign
Anxiety
Health literacy
Neuraxial Analgesia
Epidural catheter placement
Pregnancy
Parturients
Pain Catastrophizing Scale
STAI questionnaire
Companion
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.
timeFrame: Average 12 hours, up to 24 hours after epidural placement
Secondary outcomes:
measure: 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.
timeFrame: 24 hours after epidural placement
measure: Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.
timeFrame: After epidural placement
measure: What is the Preference of Subjects to Have a Companion Present for Future Procedures.
timeFrame: 24 hours after epidural placement
measure: Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
timeFrame: 24 hours after epidural
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Feyce Peralta, MD
role: PRINCIPAL_INVESTIGATOR
References: