Poke and a Placebo

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT04497220

Collaborator

(none)

Enrollment

Location

Arms

16.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Behavioral: Negative Connotation Langauge Behavioral: Positive Connotation Language	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 12, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Aaron Berg, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT04497220

Other Study ID Numbers:

ANES-2020-29006

First Posted:

Aug 4, 2020

Last Update Posted:

Mar 7, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Minnesota

Epidural Anesthesia (labor)

Study Results

No Results Posted as of Mar 7, 2022