Poke and a Placebo

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Behavioral: Negative Connotation Langauge; Behavioral: Positive Connotation Language

• Registration Number: NCT04497220
• Lead Sponsor: University of Minnesota

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-04
• Study Start: 2021-07-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• pregnancy
• requesting an epidural for the first time

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocebo Group	Negative Connotation Langauge	Participants in this group will receive the control treatment
Positive Connotation Group	Positive Connotation Language	Participants in this group will receive the experimental treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States