Loading search results

Outcome Measures

Primary Outcomes (2)

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.
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.
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.
From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate acceptability of blanket use.
From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate appropriateness of blanket use.
From baseline to the end of treatment at 2-6 weeks.
Participant and provider exit surveys will evaluate perceived effectiveness of blanket use.
From baseline to the end of treatment at 2-6 weeks.

Study Arms (2)

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.

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.

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

SUPPORTIVE CARE

Intervention Model

CROSSOVER

Model Details: 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)

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Associate Professor

Weighted Blankets for Dental Anxiety

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: Blanket @ Visit 1

Group B: Blanket @ Visit 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: Blanket @ Visit 1

Group B: Blanket @ Visit 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record