Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of California, San Diego
About this trial
The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying patients' opinions of their clinicians' empathy.
The investigators are inviting patients who have never given birth who arrive at their clinic visit seeking an IUD.
Usually, at University of California, San Diego (UCSD), for patients who have never delivered, clinicians numb both the sides of the cervix with a lidocaine-based paracervical block. The purpose of this research study is to compare perceptions of pain between lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to provide informed consent
Women presenting for IUD placement for contraception or heavy menstrual bleeding
Ages 18-50
English-speaking
Disqualifiers
History of ever giving birth
Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.
Diagnosed chronic pain condition
Current pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Xylocaine jelly 2%
DrugTo determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women
Surgilube
DrugTo determine if the placebo gel increases pain of paracervical block injection before IUD placement in nulliparous women
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: 2% lidocaine gel (Xylocaine)Experimental treatment 1 intervention
Group B: Non-Medicated Gel (Surgilube)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain scores during IUD placement procedure
Does 2% lidocaine jelly decrease pain of paracervical block injection before IUD placement procedures among nulliparous women? Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means "No pain" and 10 means "Worst pain possible."
Time frame
From speculum placement to 5 minutes post-procedure2
Patient perceptions of clinician empathy
What is the relationship between pain and feelings about clinician empathy? Empathy will be measured through answers to the 10-question Consultation and Relational Empathy (CARE) Measure. Each question is answered by a 5-point scale of how well the patient believes their clinician to be at various types of empathetic gestures, where 1 equals "poor" and 5 equals "excellent."
Time frame
From pre-procedure baseline to 5 minutes post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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