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Not Yet Recruiting NCT07879846

Weighted Blankets for Dental Anxiety

Conditions: Anxiety, Depression

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University of Pennsylvania

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.

Eligibility Criteria

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: 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07879846). StuddyBuddy aggregates publicly available trial information.