Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial

N/ANot Yet RecruitingNCT07714590

Duke University114 enrolled

Overview

The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) decreases perceived pain during the procedure. The main question it aims to answer is: Does applying a vibrating device to the umbilicus during IUD insertion significantly reduce perceived pain compared to standard of care? Researchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not. Participants will be randomly assigned to receive a vibrating device placed on the umbilicus during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device. Participants will complete a pre-procedure survey and will report their pain on a scale of 1-100 at various points during the IUD insertion procedure. Participants who received the vibrating device will also complete a post-procedure survey.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Intrauterine Device Placement

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Capable of providing informed consent * Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic * English-speaking Exclusion Criteria: * Currently pregnant * Planned use of IV sedation during IUD placement * Inability to provide informed consent due to disability or language barrier

Outcomes

Primary Outcomes

Pain score

Perceived pain will be assessed using a 100-point visual analog scale (VAS). The VAS ranges from 0 to 100 with the lower score indicating less pain and the higher score indicating greater pain.

Time frame: Pain will be assessed using a 100-point Visual Analog Scale (VAS) at multiple time points during and after the procedure (pre-procedure, with speculum placement, with tenaculum placement, immediately after uterine sound, immediately after IUD placement,

Secondary Outcomes

Satisfaction of Vibration Therapy

Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy.

Time frame: 15 minutes post-procedure

Acceptability of Vibration Therapy

Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy.