Poke and a Placebo

University of Minnesota (UMN)

Status: Enrolling

Conditions: Anesthesia

Treatments: Behavioral: Positive Connotation Language; Behavioral: Negative Connotation Langauge

Study type: Interventional

Funder types: Other

Identifiers

NCT04497220

ANES-2020-29006

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Nocebo Group

Placebo Comparator group

Description:

Participants in this group will receive the control treatment

Treatment:

Behavioral: Negative Connotation Langauge

Positive Connotation Group

Experimental group

Description:

Participants in this group will receive the experimental treatment.

Treatment:

Behavioral: Positive Connotation Language