Presence of a Companion During Performance of Neuraxial Labor Analgesia
Condition: Anxiety; Pain; Health Knowledge, Attitudes, Practice
Study type: Interventional

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.
    

Intervention name(s): Companion Present
Intervention type(s): Other
Intervention description(s): A companion will be present during the epidural catheter placement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Newest Vital Sign; Anxiety; Health literacy; Neuraxial Analgesia; Epidural catheter placement; Pregnancy; Parturients; Pain Catastrophizing Scale; STAI questionnaire; Companion