Intra-uterine Device PlacementPhase 1NCT06969365
Weighted Blankets for IUD Insertion
A Phase 1 study testing 10-pound weighted lap-pad and blanket in people with Intra-uterine Device Placement, run by Saint Luke's Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intra-uterine Device Placement
- What is being tested?
- 10-pound weighted lap-pad and blanket
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Oct 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled for IUD placement
- age 18 years or older
- able to read and understand English and use a pen
Who cannot join
- inability to consent
- inability to remove weighted blanket
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?
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.
Read the detailed description
Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.
- Conditions
- Intra-uterine Device Placement
- Being tested
- 10-pound weighted lap-pad, blanket
- Keywords
- weighted blanket, gynecological procedure, IUD, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-pound weighted lap-padOther
10-pound weighted lap pad will be placed over the patient's chest and shoulders
blanketOther
A simple, unweighted blanket will be applied to patients during IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Experimental | A weighted blanket will be applied to the patient during IUD placement Receives: Other: 10-pound weighted lap-pad |
| Non-weighted blanket | Sham comparator | A non-weighted light blanket will be applied to patient during IUD insertion Receives: Other: blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale - Anxiety
Patients will make a mark on a 100 mm line to indicate level of anxiety
Measured: At the conclusion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Mar 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-uterine Device PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Guastello, BSN, Principal investigator, Saint Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969365
- Sponsor's protocol ID
- SLHS-24-088
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31882291
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?
- ClinicalTrials.gov ID
- NCT06969365
- Acronym / sponsor ID
- SLHS-24-088
- Conditions
- Intra-uterine Device Placement
- Keywords
- weighted blanket, gynecological procedure, IUD, anxiety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Experimental | Other: 10-pound weighted lap-padA weighted blanket will be applied to the patient during IUD placement |
| Non-weighted blanket | Sham comparator | Other: blanketA non-weighted light blanket will be applied to patient during IUD insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for IUD placement
- age 18 years or older
- able to read and understand English and use a pen
Key exclusion criteria (2 listed)
- inability to consent
- inability to remove weighted blanket
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-pound weighted lap-pad10-pound weighted lap pad will be placed over the patient's chest and shoulders | Other | Weighted blanket |
| blanketA simple, unweighted blanket will be applied to patients during IUD insertion | Other | Non-weighted blanket |
Primary outcome
Visual Analog Scale - Anxiety
Time frame: At the conclusion of the procedure
Patients will make a mark on a 100 mm line to indicate level of anxiety
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 31882291Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Guastello, BSN principal investigator
Saint Luke's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10-pound weighted lap-pad and blanket in people with Intra-uterine Device Placement, run by Saint Luke's Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale - Anxiety (time frame: At the conclusion of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06969365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.