AnxietyNCT07879846
Weighted Blankets for Dental Anxiety
A study testing Blanket at visit 1., No blanket at visit 1 and Blanket at visit 2. in people with Anxiety and Depression, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Blanket at visit 1., No blanket at visit 1 and Blanket at visit 2.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Aug 2027
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- 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.
- 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
- History of at least one prior dental appointment involving the use of local anesthesia
- Scheduled for two routine dental appointments at PDM that:
- Will be completed by the same student dental provider, and
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- Involve procedures within the same procedure category, and
- Require the use of local anesthesia
- Eligible procedure categories include
- Restorative procedures: restorative filling
- Prosthodontic procedures: crown prep, crown cementation, bridge prep, post and core
- Periodontal procedures: scaling and root planing (SRP) or selective SRP
- 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.
- Ability to understand study procedures and provide informed consent
Who cannot join
- Age under 18 years
- 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
- American Society of Anesthesiologists (ASA) Physical Status Classification III or higher
- 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
- Current use of medications that significantly affect autonomic or cardiovascular responses
- Beta-blockers
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- Anticholinergics
- Opioids
- Stimulants
- Use of short-acting anxiolytics or sedatives within 48 hours prior to study visit
- Respiratory compromise that may make weighted blanket use unsafe
- Moderate to severe or uncontrolled asthma
- Diagnosed Obstructive Sleep Apnea
- Known allergy, skin condition, or sensitivity that would preclude safe or comfortable use of a weighted blanket
- Current regular use of weighted blankets or similar deep pressure devices for anxiety management outside of the study
- Any condition or circumstance, in the opinion of the investigator, that would make participation unsafe or interfere with the completion of study procedures
About this study
Official title: Effects of Weighted Blankets on Physiologic and Subjective Anxiety Measures in Adults With Dental Anxiety: A Randomized Crossover Study
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.
- Conditions
- Anxiety, Depression
- Being tested
- Blanket at visit 1., No blanket at visit 1, Blanket at visit 2., No blanket at visit 2
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blanket at visit 1.Behavioural
Routine dental procedure with 3 lb weighted blanket providing deep touch pressure.
No blanket at visit 1Other
Routine dental care without weighted blanket.
Blanket at visit 2.Behavioural
Routine dental procedure with 3 lb weighted blanket providing deep touch pressure.
No blanket at visit 2Other
Routine dental care without weighted blanket.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Blanket @ Visit 1 | Experimental | 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. Receives: Behavioral: Blanket at visit 1.; Other: No blanket at visit 2 |
| Group B: Blanket @ Visit 2 | Experimental | During visit 1 patient will undergo routine dental procedure without weighted blanket. During visit 2 patient will undergo dental routine procedure with weighted blanket. Receives: Other: No blanket at visit 1; Behavioral: Blanket at visit 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
Secondary outcomes (4)
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
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.
Measured: From baseline to the end of treatment at 2-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention consists of a 3 lb weighted blanket providing deep touch pressure applied during routine dental treatment. Each participant will undergo 1. One visit with weighted blanket 2. One visit without weighted blanket (control)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Risner-Bauman, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879846
- Sponsor's protocol ID
- 26-7235
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weighted Blankets on Physiologic and Subjective Anxiety Measures in Adults With Dental Anxiety: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07879846
- Acronym / sponsor ID
- 26-7235
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention consists of a 3 lb weighted blanket providing deep touch pressure applied during routine dental treatment. Each participant will undergo 1. One visit with weighted blanket 2. One visit without weighted blanket (control)
| Arm | Type | Receives |
|---|---|---|
| Group A: Blanket @ Visit 1 | Experimental | Behavioral: Blanket at visit 1., Other: No blanket at visit 2Apply 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. |
| Group B: Blanket @ Visit 2 | Experimental | Other: No blanket at visit 1, Behavioral: Blanket at 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults aged 18 years or older
- 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.
- 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
- History of at least one prior dental appointment involving the use of local anesthesia
- Scheduled for two routine dental appointments at PDM that:
Key exclusion criteria (16 listed)
- Age under 18 years
- 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
- American Society of Anesthesiologists (ASA) Physical Status Classification III or higher
- 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
- Current use of medications that significantly affect autonomic or cardiovascular responses
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 |
|---|---|---|
| Blanket at visit 1.Routine dental procedure with 3 lb weighted blanket providing deep touch pressure. | Behavioural | Group A: Blanket @ Visit 1 |
| No blanket at visit 1Routine dental care without weighted blanket. | Other | Group B: Blanket @ Visit 2 |
| Blanket at visit 2.Routine dental procedure with 3 lb weighted blanket providing deep touch pressure. | Behavioural | Group B: Blanket @ Visit 2 |
| No blanket at visit 2Routine dental care without weighted blanket. | Other | Group A: Blanket @ Visit 1 |
Primary outcome
Evaluate differences in psychological anxiety measure.
Time frame: From baseline to the end of treatment at 2-6 weeks.
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.
Evaluate differences in physiological anxiety measure
Time frame: From baseline to the end of treatment at 2-6 weeks.
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.
4 secondary outcomes
Participant and provider exit surveys will evaluate feasibility of blanket use.
Time frame: From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate acceptability of blanket use.
Time frame: From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate appropriateness of blanket use.
Time frame: From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate perceived effectiveness of blanket use.
Time frame: From baseline to the end of treatment at 2-6 weeks.
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 19 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blanket at visit 1., No blanket at visit 1 and Blanket at visit 2. in people with Anxiety and Depression, run by University of Pennsylvania.
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 14 inclusion and 16 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Evaluate differences in psychological anxiety measure. (time frame: From baseline to the end of treatment at 2-6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.