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NCT Number: NCT04497220

Poke and a Placebo

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

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Candace Nelson

CONTACT

[email protected]

612-626-2465

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Connotation Langauge

Behavioral

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

Behavioral

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 outcomes

  1. Max pain score during the epidural procedure

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Overall satisfaction during the epidural procedure

    Time frame: 1 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Berg, MD

CONTACT

[email protected]

612-624-9990

Jonah Pearson, MD

CONTACT

[email protected]

612-625-6659

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2020
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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