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RecruitingNCT04497220Updated Jan 8, 2026

Poke and a Placebo

An interventional study of Negative Connotation Langauge and Positive Connotation Language in Anesthesia, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.

Read the detailed description

The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording "Poke and a burn" prior to subcutaneous local anesthetic administration for the epidural placement and one will contain "this is numbing medication, which will make the rest of the procedure go easier". There will be no difference in the epidural placement, medications, or the rest of the script.

02

Conditions studied

  • Anesthesia

Keywords

  • Epidural Anesthesia (labor)
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnancy
  • requesting an epidural for the first time

Exclusion criteria

Exclusion Criteria:

  • previous epidural (either for labor or for surgery)
  • BMI greater than 40 kg/m\^2
  • previous lumbar spine surgery
  • inability to speak English
  • a history of chronic pain or are on chronic opioids
  • a history of opioid drug abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    Nocebo Group

    Participants in this group will receive the control treatment

    Behavioral: Negative Connotation Langauge

  • Experimental
    Positive Connotation Group

    Participants in this group will receive the experimental treatment.

    Behavioral: Positive Connotation Language

Interventions

  • BehavioralNegative Connotation Langauge

    The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The control script includes language containing the wording "Poke and a burn" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.

  • BehavioralPositive Connotation Language

    The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The experimental script includes language containing the wording "this is numbing medication, which will make the rest of the procedure go easier" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.

06

What researchers measure

Primary outcomes

  1. Max pain score during the epidural procedure

    Maximum pain score will be measured using a single 11-point Numeric Rating Scale 0-10, where 0 is no pain and 10 is maximum imaginable pain.

    Time frame: 1 hour

Secondary outcomes

  1. Overall satisfaction during the epidural procedure

    Overall satisfaction during the epidural procedure will be measured used a 5-point likert scale: 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, 1=very dissatisfied.

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04497220
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Aug 4, 2020
Start date
Jul 12, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 8, 2026

Study contacts

Aaron Berg, MD
Contact
bergx831@umn.edu
612-624-9990
Jonah Pearson, MD
Contact
pears731@umn.edu
612-625-6659
Aaron Berg, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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