Poke and a Placebo

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497220
• Other study ID #: ANES-2020-29006
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Aaron Berg, MD
• Phone: 612-624-9990
• Email: bergx831[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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