Poke and a Placebo

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04497220

Enrollment

Registered

2020-08-04

Start date

2021-07-12

Completion date

2026-12-31

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Epidural Anesthesia (labor)

Brief summary

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

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Max pain score during the epidural procedure	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

Measure	Time frame	Description
Overall satisfaction during the epidural procedure	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.

Countries

United States

Contacts

Primary ContactAaron Berg, MD

bergx831@umn.edu612-624-9990

Backup ContactJonah Pearson, MD

pears731@umn.edu612-625-6659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026