NCT06969365

Brief Summary

When having an intrauterine device placed in an outpatient clinic, patients frequently feel anxiety related to the procedure. This study is designed to determine if the use of a small, weighted blanket, placed over the patient's chest and shoulders, would help decrease that anxiety, as well as pain related to the procedure.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

April 23, 2025

Last Update Submit

May 7, 2025

Conditions

Intra-uterine Device Placement

Keywords

weighted blanketgynecological procedureIUDanxiety

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale - Anxiety

    Patients will make a mark on a 100 mm line to indicate level of anxiety

    At the conclusion of the procedure

Study Arms (2)

Weighted blanket

EXPERIMENTAL

A weighted blanket will be applied to the patient during IUD placement

Other: 10-pound weighted lap-pad

Non-weighted blanket

SHAM COMPARATOR

A non-weighted light blanket will be applied to patient during IUD insertion

Other: blanket

Interventions

10-pound weighted lap-padOTHER

10-pound weighted lap pad will be placed over the patient's chest and shoulders

Weighted blanket
blanketOTHER

A simple, unweighted blanket will be applied to patients during IUD insertion

Non-weighted blanket

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for IUD placement
  • age 18 years or older
  • able to read and understand English and use a pen

You may not qualify if:

  • inability to consent
  • inability to remove weighted blanket

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.

    PMID: 31882291BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Anna Guastello, BSN

    Saint Luke's Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 13, 2025

Study Start

March 1, 2025

Primary Completion

August 31, 2025

Study Completion

October 1, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)