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Poke and a Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497220
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Behavioral: Negative Connotation Langauge Behavioral: Positive Connotation Language Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 12, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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.




Primary Outcome Measures :
  1. Max pain score during the epidural procedure [ Time Frame: 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 :
  1. Overall satisfaction during the epidural procedure [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497220


Contacts
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Contact: Aaron Berg, MD 612-624-9990 bergx831@umn.edu
Contact: Jonah Pearson, MD 612-625-6659 pears731@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Candace Nelson    612-626-2465    nelso377@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Aaron Berg, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04497220    
Other Study ID Numbers: ANES-2020-29006
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Epidural Anesthesia (labor)