Poke and a Placebo
Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 8, 2026
January 1, 2026
5.5 years
July 29, 2020
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall satisfaction during the epidural procedure
1 hour
Study Arms (2)
Nocebo Group
PLACEBO COMPARATORParticipants in this group will receive the control treatment
Positive Connotation Group
EXPERIMENTALParticipants in this group will receive the experimental treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- pregnancy
- requesting an epidural for the first time
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Berg, MD
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2020
First Posted
August 4, 2020
Study Start
July 12, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 8, 2026
Record last verified: 2026-01