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Not yet recruitingNCT07879846Updated Oct 19, 2026

Weighted Blankets for Dental Anxiety

An interventional study of Blanket at visit 1. and No blanket at visit 1 in Anxiety and Depression, sponsored by University of Pennsylvania. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this project is to determine the effectiveness of weighted blankets as an anxiety-reducing intervention for neurotypical adult patients with dental anxiety undergoing routine dental procedures at the University of Pennsylvania School of Dental Medicine. This study will evaluate heart rate, subjective anxiety levels, and provider and participant perceptions of weighted blanket use.

02

Conditions studied

  • Anxiety
  • Depression
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Browse University of Pennsylvania studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged 18 years or older
  2. Individuals presenting for their first dental appointment at Penn Dental Medicine in the Primary Care Unit (PCU) clinics or Personalized Care Suite, treated by a 3rd or 4th year dental student. Prior triage or emergency/urgent care visits are permitted.
  3. Self-reported elevated dental anxiety, as determined by a score of ≥ 4 on the PDM dental anxiety/fear scale completed as part of the standard medical history
  4. History of at least one prior dental appointment involving the use of local anesthesia

  5. Scheduled for two routine dental appointments at PDM that:

    1. Will be completed by the same student dental provider, and
    2. Involve procedures within the same procedure category, and
    3. Require the use of local anesthesia

  6. Eligible procedure categories include

    1. Restorative procedures: restorative filling
    2. Prosthodontic procedures: crown prep, crown cementation, bridge prep, post and core
    3. Periodontal procedures: scaling and root planing (SRP) or selective SRP
  7. Individuals with non-dental anxiety or stable psychiatric conditions may be included, provided they are on stable psychotropic medication regimens with unchanged dose for ≥ 4 weeks prior to study participation, excluding medications otherwise listed in the exclusion criteria that may significantly affect autonomic responses.
  8. Ability to understand study procedures and provide informed consent

Exclusion criteria

Exclusion Criteria:

  1. Age under 18 years
  2. Self-reported or documented diagnosis of a neurological or neurodevelopment condition that could influence anxiety response or sensory processing. This exclusion is intended to limit variability and to focus the study on a neurotypical adult population
  3. American Society of Anesthesiologists (ASA) Physical Status Classification III or higher
  4. Pregnancy or suspected pregnancy at the time of study participation. Pregnancy is associated with physiological changes that may influence anxiety and autonomic responses. Pregnant individuals are excluded to minimize confounding and to avoid additional regulatory requirements associated with research involving pregnant populations

  5. Current use of medications that significantly affect autonomic or cardiovascular responses

    • Beta-blockers
    • Anticholinergics
    • Opioids
    • Stimulants
  6. Use of short-acting anxiolytics or sedatives within 48 hours prior to study visit

  7. Respiratory compromise that may make weighted blanket use unsafe

    • Moderate to severe or uncontrolled asthma
    • Diagnosed Obstructive Sleep Apnea
  8. Known allergy, skin condition, or sensitivity that would preclude safe or comfortable use of a weighted blanket
  9. Current regular use of weighted blankets or similar deep pressure devices for anxiety management outside of the study
  10. Any condition or circumstance, in the opinion of the investigator, that would make participation unsafe or interfere with the completion of study procedures
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Group A: Blanket @ Visit 1

    Apply weighted blanket after collecting baseline data and prior to the administration of local anesthesia during visit 1. During visit 2 patient will undergo dental routine procedure without weighted blanket.

    Behavioral: Blanket at visit 1. · Other: No blanket at visit 2

  • Experimental
    Group B: Blanket @ Visit 2

    During visit 1 patient will undergo routine dental procedure without weighted blanket. During visit 2 patient will undergo dental routine procedure with weighted blanket.

    Other: No blanket at visit 1 · Behavioral: Blanket at visit 2.

Interventions

  • BehavioralBlanket at visit 1.

    Routine dental procedure with 3 lb weighted blanket providing deep touch pressure.

  • OtherNo blanket at visit 1

    Routine dental care without weighted blanket.

  • BehavioralBlanket at visit 2.

    Routine dental procedure with 3 lb weighted blanket providing deep touch pressure.

  • OtherNo blanket at visit 2

    Routine dental care without weighted blanket.

06

What researchers measure

Primary outcomes

  1. Evaluate differences in psychological anxiety measure.

    Evaluate differences psychological anxiety between intervention groups using the six-item Spielberger State-Trait Anxiety Inventory (STAI-6). The STAI-6 consists of six statements rated on a 4-point Likert scale, yielding a total score ranging from 6 to 24. Lower scores indicate lower levels of anxiety, while higher scores indicate greater anxiety.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

  2. Evaluate differences in physiological anxiety measure

    Pulse rate will be measured before dental procedure, during procedure, and after procedure. Lower pulse rates indicate lower anxiety while higher pulse rates indicate higher anxiety measures.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

Secondary outcomes

  1. Participant and provider exit surveys will evaluate feasibility of blanket use.

    Participant and provider exit surveys will be analyzed using descriptive statistics, and where appropriate, paired comparisons.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

  2. Participant and provider exit surveys will evaluate acceptability of blanket use.

    Participant and provider exit surveys will be analyzed using descriptive statistics, and where appropriate, paired comparisons.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

  3. Participant and provider exit surveys will evaluate appropriateness of blanket use.

    Participant and provider exit surveys will be analyzed using descriptive statistics, and where appropriate, paired comparisons.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

  4. Participant and provider exit surveys will evaluate perceived effectiveness of blanket use.

    Participant and provider exit surveys will be analyzed using descriptive statistics, and where appropriate, paired comparisons.

    Time frame: From baseline to the end of treatment at 2-6 weeks.

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07879846
Lead sponsor
University of Pennsylvania
Responsible party
Alicia Risner-Bauman (Associate Professor, University of Pennsylvania) — Principal investigator
First posted
Oct 19, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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