AnxietyCompanionNCT02982213
Presence of a Companion During Performance of Neuraxial Labor Analgesia
A study testing Companion Present in people with Anxiety and Pain, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anxiety, Pain, Health Knowledge, Attitudes, Practice
- What is being tested?
- Companion Present
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety, Pain, Health Knowledge, Attitudes, Practice
- Being tested
- Companion Present
- Keywords
- Newest Vital Sign, Anxiety, Health literacy, Neuraxial Analgesia, Epidural catheter placement, Pregnancy, Parturients, Pain Catastrophizing Scale, STAI questionnaire, Companion
- Medical subject headings
- Anxiety Disorders, Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Companion PresentOther
A companion will be present during the epidural catheter placement.
| Study group | Role | What they receive |
|---|---|---|
| No companion present | No intervention | No companion is present during the placement of the epidural catheter. |
| Companion present | Active comparator | A companion will be present during the placement of the epidural catheter. Receives: Other: Companion Present |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Average 12 hours, up to 24 hours after epidural placement
Secondary outcomes (4)
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.
Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.
Measured: 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.
Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).
Measured: After epidural placement
What is the Preference of Subjects to Have a Companion Present for Future Procedures.
What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.
Measured: 24 hours after epidural placement
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.
Measured: 24 hours after epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyce M. Peralta, MD, MS, Northwestern University
- Investigators
- Feyce Peralta, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982213
- Sponsor's protocol ID
- STU00203896
- Acronym
- Companion
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2016
- Last updated
- 12 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of a Companion During Performance of Neuraxial Labor Analgesia
- ClinicalTrials.gov ID
- NCT02982213
- Acronym / sponsor ID
- Companion / STU00203896
- Conditions
- Anxiety, Pain, Health Knowledge, Attitudes, Practice
- Keywords
- Newest Vital Sign, Anxiety, Health literacy, Neuraxial Analgesia, Epidural catheter placement, Pregnancy, Parturients, Pain Catastrophizing Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No companion present | No intervention | –No companion is present during the placement of the epidural catheter. |
| Companion present | Active comparator | Other: Companion PresentA companion will be present during the placement of the epidural catheter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Companion PresentA companion will be present during the epidural catheter placement. | Other | Companion present |
Primary outcome
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.
Time frame: Average 12 hours, up to 24 hours after epidural placement
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
4 secondary outcomes
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.
Time frame: 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.
Time frame: After epidural placement
What is the Preference of Subjects to Have a Companion Present for Future Procedures.
Time frame: 24 hours after epidural placement
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
Time frame: 24 hours after epidural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feyce Peralta, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Companion Present in people with Anxiety and Pain, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. (time frame: Average 12 hours, up to 24 hours after epidural placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.