NCT02982213|CompletedResults
Presence of a Companion During Performance of Neuraxial Labor Analgesia
Companion
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Companion
Sponsor study identifier
interventional
150
1 country
1
Study Start
December 1, 2016
Actual (reported)Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 1, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2016
Actual (reported)December 1, 2016
Actual (reported)December 5, 2016
Actual (reported)April 1, 2017
Actual (reported)April 1, 2017
Actual (reported)January 26, 2021
Actual (reported)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
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.
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.
No companion is present during the placement of the epidural catheter.
A companion will be present during the placement of the epidural catheter.
A companion will be present during the epidural catheter placement.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Prentice Women's Hospital
Chicago, Illinois, 60611, United States
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.
Feyce Peralta, MD
Northwestern University
150 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2016
First Posted
December 5, 2016
Study Start
December 1, 2016
Actual (reported)Lavender Aromatherapy for Anxiety During Urodynamics
After epidural placement
What is the Preference of Subjects to Have a Companion Present for Future Procedures.
24 hours after epidural placement
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
24 hours after epidural
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 1, 2017
Actual (reported)Last Updated
November 12, 2021
Results First Posted
January 26, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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