N/A
N=150
Presence of a Companion During Performance of Neuraxial Labor Analgesia
Anxiety · Pain · Health Knowledge, Attitudes, Practice
Bottom Line
View on ClinicalTrials.gov: NCT02982213 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. — 2; 2; 3; 0 Participants — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Companion Present (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. |
2; 2; 3; 0; 11; 1 | .001 sig |
| 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. |
-7; -11 | — |
| SECONDARY Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter. |
8; 8 | — |
| SECONDARY What is the Preference of Subjects to Have a Companion Present for Future Procedures. |
17; 30; 14; 15; 22; 14 | — |
| SECONDARY Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. |
32; 59; 10; 11; 22; 2 | .001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02982213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.