Poke and a Placebo
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|ClinicalTrials.gov Identifier: NCT04497220|
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : February 21, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Behavioral: Negative Connotation Langauge Behavioral: Positive Connotation Language||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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 2023|
|Estimated Study Completion Date :||December 2023|
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- requesting an epidural for the first time
- 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
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
|Contact: Aaron Berg, MDemail@example.com|
|Contact: Jonah Pearson, MDfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Candace Nelson 612-626-2465 email@example.com|
|Principal Investigator:||Aaron Berg, MD||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||August 4, 2020 Key Record Dates|
|Last Update Posted:||February 21, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Epidural Anesthesia (labor)