Poke and a Placebo

NCT ID: NCT04497220

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nocebo Group

Participants in this group will receive the control treatment

Group Type PLACEBO_COMPARATOR

Negative Connotation Langauge

Intervention Type 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 Group

Participants in this group will receive the experimental treatment.

Group Type EXPERIMENTAL

Positive Connotation Language

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Berg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aaron Berg, MD

Role: CONTACT

612-624-9990

Jonah Pearson, MD

Role: CONTACT

612-625-6659

Facility Contacts

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Candace Nelson

Role: primary

612-626-2465

Other Identifiers

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ANES-2020-29006

Identifier Type: -

Identifier Source: org_study_id

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