Periumbilical Vibration for Pain During IUD Placement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether using a vibrating device on the belly button area can reduce pain during IUD insertion. Researchers compare the experiences of those using the Periumbilical Vibration Device to those who do not, to assess its effectiveness in pain relief. Participants will report their pain levels on a scale during the procedure. This trial may suit English-speaking individuals scheduled for IUD insertion at specific clinics who can provide informed consent. As an unphased trial, it offers a unique opportunity to contribute to innovative pain management research during IUD insertion.
What prior data suggests that this vibrating device is safe for use during IUD placement?
Studies have shown that using a vibrating device on the belly button during IUD insertion might help reduce pain. This method is generally considered safe. Research has not found any serious side effects from the vibration itself. Some clinics already use this technique, suggesting it is well-tolerated. Most reports focus on its ability to ease discomfort rather than cause harm. Overall, past experiences indicate that using a vibrating device does not pose significant safety concerns for people receiving an IUD.12345
Why are researchers excited about this trial?
Researchers are excited about using a periumbilical vibration device during IUD placement because it offers a potentially pain-reducing technique that differs from traditional methods. Unlike standard care, which might involve pain relief through medication, this method uses a handheld vibrating device placed at the belly button area. The vibration is thought to disrupt pain signals, offering a novel, non-invasive way to manage discomfort during the procedure. This approach could make the experience more comfortable for patients, reducing the need for additional pain medication.
What evidence suggests that the periumbilical vibration device is effective for reducing pain during IUD placement?
This trial will compare the use of a vibrating device near the belly button with standard care during IUD placement. Research has shown that a vibrating device can reduce pain during the procedure. One study found that participants experienced significantly less pain with the device. The vibration distracts the brain from pain signals, making the process more comfortable. These findings suggest that vibration near the belly button can effectively manage pain during IUD insertion.46789
Who Is on the Research Team?
Beverly Gray, MD
Principal Investigator
Duke Health
Are You a Good Fit for This Trial?
This trial is for people scheduled to have an intrauterine device (IUD) placed. There are no specific inclusion or exclusion criteria listed, so it appears open to anyone undergoing IUD insertion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo IUD insertion with or without the vibrating device at the umbilicus
Immediate Post-Procedure
Participants complete post-procedure surveys to assess pain and satisfaction
Follow-up
Participants are monitored for any immediate adverse effects and overall satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Periumbilical Vibration Device
Trial Overview
The study tests whether using a vibrating device on the belly button area during IUD placement reduces pain compared to not using the device. Participants are randomly assigned to either receive vibration or standard care, and all can use usual pain relief methods.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.
Participants assigned to this arm will not have a vibrating device placed at the umbilicus during intrauterine device placement. They will receive standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Citations
Advancing Pain Management Protocols for Intrauterine Device ...
Patients' overall pain throughout the treatment was significantly reduced by using 40mg of 10% lidocaine spray (average of pain at IUD ...
Effect of Periumbilical Vibration on Pain Perception During ...
The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) ...
3.
researchgate.net
researchgate.net/publication/411855562_Pain_control_options_for_intrauterine_device_placement_and_endometrial_biopsyPain control options for intrauterine device placement and ...
Paracervical block significantly reduced pain scores during IUD placement, tenaculum placement, uterine sounding, and post-IUD placement ( p < ...
Pain Management During Intrauterine Device Insertion ... - PMC
The results from this study demonstrated a significant reduction in pain during cervical grasping and IUD insertion with the use of both ...
5.
medschool.umich.edu
medschool.umich.edu/department-news/researchers-publish-paper-social-media-descriptions-experiences-pain-during-iud-placementResearchers publish paper on social media descriptions ...
The study's aim was to explore the experiences of social media users with pain, trauma, and pain management during IUD insertion. Social media ...
Intrauterine Device Placement and Removal - StatPearls - NCBI
Malpositioned IUDs are often located in the lower uterus, potentially causing abnormal bleeding, pain, and an increased risk of pregnancy. IUD ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/ab25b28b671af312/nct07714590-periumbilical-vibration-pain-intrauterine-device-insertionEffect of Periumbilical Vibration on Pain... | Clinical Trial
The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine ...
Intrauterine Contraception
timing of Cu-IUD placement in relation to the menstrual cycle in nonpostpartum women had little effect on long-term outcomes
PATIENT REACTIONS AND ONE PROVIDER'S APPROACH
Umbilical vibration may serve as an effective, low-cost option to reduce pain during IUD placement. Providers considering this technique should ...
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