Poke and a Placebo

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

Detailed Description
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Behavioral: Negative Connotation Langauge
* Behavioral: Positive Connotation Language


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nocebo Group<br>Participants in this group will receive the control treatment | Behavioral: Negative Connotation Langauge<br>* 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.<br>|
| Experimental: Positive Connotation Group<br>Participants in this group will receive the experimental treatment. | Behavioral: Positive Connotation Language<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Anesthesia (labor)