Recruiting

Poke

Sponsor:

University of Minnesota

Code:

NCT04497220

Conditions

Anesthesia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Negative Connotation Langauge

Positive Connotation Language

Study Details

Brief summary:

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

Conditions

Anesthesia

Study ID

NCT04497220

Start date

Jul 12, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • pregnancy
  • requesting an epidural for the first time

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Nocebo Group

Participants in this group will receive the control treatment

experimental: Positive Connotation Group

Participants in this group will receive the experimental treatment.

Interventions

Negative 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.

Positive 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.

Primary outcome measure

  • Max pain score during the epidural procedure [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Aaron Berg, MD

612-624-9990bergx831@umn.edu

Jonah Pearson, MD

612-625-6659pears731@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Candace Nelson

612-626-2465nelso377@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Epidural Anesthesia (labor)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-08.