Poke and a Placebo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative Connotation Langauge, Positive Connotation Language.
- Who it may be relevant to
- Registry conditions: Anesthesia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial
Overview
To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.
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.
Interventions
- 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. - 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
- Max pain score during the epidural procedure [Time frame: 1 hour]
Secondary outcome measures (1)
- Overall satisfaction during the epidural procedure [Time frame: 1 hour]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT04497220 · ANES-2020-29006