Periumbilical Vibration for Pain During IUD Placement

MT
Overseen ByMadeline Thornton, MD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

BG

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

I am able to understand and agree to participate in this study.
Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic
English-speaking
See 1 more

Exclusion Criteria

Currently pregnant
I plan to have IV sedation when my IUD is placed.
I am unable to give informed consent because of a disability or language barrier.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo IUD insertion with or without the vibrating device at the umbilicus

1 day
1 visit (in-person)

Immediate Post-Procedure

Participants complete post-procedure surveys to assess pain and satisfaction

15 minutes

Follow-up

Participants are monitored for any immediate adverse effects and overall satisfaction

1 week

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

Group I: Periumbilical Placement of Vibrating DeviceExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

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) ...

Pain 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 ...

Researchers 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 ...

Effect 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 ...