Poke and a Placebo

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

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

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Behavioral: Negative Connotation Langauge; Behavioral: Positive Connotation Language

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron Berg, MD; Phone Number: 612-624-9990; Email: bergx831@umn.edu
• Study Contact Backup: Name: Jonah Pearson, MD; Phone Number: 612-625-6659; Email: pears731@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Candace Nelson; Phone Number: 612-626-2465; Email: nelso377@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Nocebo Group; Participants in this group will receive the control treatment	Behavioral: 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.
Experimental: Positive Connotation Group; Participants in this group will receive the experimental treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Max pain score during the epidural procedure	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction during the epidural procedure	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.	1 hour

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Aaron Berg, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Epidural Anesthesia (labor)
• Other Study ID Numbers: ANES-2020-29006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No