Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Duration of Distress Behaviors
研究概览
简要总结
This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the practicalities of this study and the need to (or not to) modify dental environments and/or provide modeling videos for each participant, blinding of treatment condition for patients or dentists is not applicable. However, for EDA recordings, research team members analyzing/coding data will be masked to condition (SADE, VBM, VBM-SADE, RDE).
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 6 through 12 years, of any race/ethnicity;
- •English- or Spanish-speaking child and parent;
- •Have experienced at least one prior dental cleaning;
- •If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited).
排除标准
- •Dental cleaning within the previous 4 months (i.e., not in need of cleaning);
- •Plan to move out of the area within 6 months;
- •Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties);
- •Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures);
- •Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings);
- •Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months
研究组 & 干预措施
Regular Dental Environment (RDE)
Participants randomized to a RDE will have their dental cleaning administered in a traditional manner (oral examination, prophylaxis, fluoride application) using tell-show-do and basic behavior guidance techniques including positive reinforcement.
Video-based Modeling (VBM)
Participants randomized to VBM will view a 5-minute video on an iPad that depicts a dental cleaning (oral examination, prophylaxis, and fluoride varnish application) being performed on a sex and age-matched (6-9 yrs v.s 10-12 yrs) cooperative child. This video will feature the model beginning in the waiting room, undertaking a successful cleaning in the absence of any signs of anxiety, choosing a small toy from the dental clinic treasure box, and receiving parental and dentist praise for good behavior.
干预措施: Video-based Modeling (Other)
Sensory Adapted Dental Environment (SADE)
Participants randomized to the SADE will receive their dental cleaning in a environment in which modifications have been made to visual, auditory, and deep pressure (tactile) stimuli to minimize sensory-related discomforts and maximize relaxation. Visual adaptations include: all direct overhead fluorescent lighting and dental overhead lamp will be turned off; black-out curtains will cover the windows; and application of adapted lighting, which will include slow moving visual color effects (Snoezelen) and the dentist wearing a surgical dental headlamp to direct light into the child's mouth, not eyes. Auditory stimuli will include calming rhythmic music projected via portable speakers. Tactile deep pressure stimuli will be provided via a commercially available weighted blanket placed on the child to provide deep "hugging" pressure, which produces a calming effect.
干预措施: Sensory Adapted Dental Environment (Other)
Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE)
Participants randomized to VBM-SADE will view a modeling video prior to their dental cleaning (see Video-based Modeling description) and experience their dental cleaning in a sensory adapted dental environment (see Sensory Adapted Dental Environment description); the pre-cleaning modeling video will portray the same procedural content as in the VBM-only condition, but with the SADE modifications made to the room in which the child actor receives his/her cleaning.
干预措施: Sensory Adapted Dental Environment (Other)
Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE)
Participants randomized to VBM-SADE will view a modeling video prior to their dental cleaning (see Video-based Modeling description) and experience their dental cleaning in a sensory adapted dental environment (see Sensory Adapted Dental Environment description); the pre-cleaning modeling video will portray the same procedural content as in the VBM-only condition, but with the SADE modifications made to the room in which the child actor receives his/her cleaning.
干预措施: Video-based Modeling (Other)
结局指标
主要结局
Duration of Distress Behaviors
时间窗: Periprocedural
Duration of distress behaviors will be scored from video-recordings of the dental cleanings. A trained research team member will assess the duration of verbal distress behaviors (whimper/cry/scream).
Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR])
时间窗: Periprocedural
Electrodermal Activity (EDA; frequency of non-specific skin conductance responses \[NS-SCR\]) reflects the activation of the sympathetic 'fight or flight' nervous system and is well-documented to increase in stressful or painful situations. A BIOPAC MP160 System will be used to record the child's EDA. The child will relax in dental chair for three minutes in order to obtain a resting baseline EDA measurement, followed by EDA recording for the duration of the dental cleaning.
Frequency of Distress Behaviors
时间窗: Periprocedural
Frequency of distress behaviors will be scored from video-recordings of the dental cleanings. A trained research team member will assess the count of mouth movements, head movements, and verbal distress behaviors (whimper/cry/scream).
Electrodermal Activity (EDA; Skin Conductance Level [SCL])
时间窗: Periprocedural
Electrodermal Activity (EDA; skin conductance level \[SCL\]) reflects the activation of the sympathetic 'fight or flight' nervous system and is well-documented to increase in stressful or painful situations. A BIOPAC MP160 System will be used to record the child's EDA. The child will relax in dental chair for three minutes in order to obtain a resting baseline EDA measurement, followed by EDA recording for the duration of the dental cleaning.
次要结局
- Caregiver Intervention Experience Form(Collected immediately after each dental cleaning)
- Dentist Intervention Experience Form(Collected immediately after each dental cleaning)
- Child Intervention Experience Form(Collected immediately after each dental cleaning)
- Frankl Scale(Collected immediately after each dental cleaning)
- Anxiety and Cooperation Scale(Collected immediately after each dental cleaning)
- Wong Baker Faces Pain Scale(Collected immediately after each dental cleaning)
- Dental Sensory Sensitivity Scale(Collected immediately after each dental cleaning)
- Subjective Thoroughness of Cleaning Scale(Collected immediately after each dental cleaning)
- Client Satisfaction Questionnaire(Collected immediately after each dental cleaning)
- State-Trait Anxiety Inventory - Short Form(Collected immediately after each dental cleaning)
- Stress Appraisal Measure(Collected immediately after each dental cleaning)
- Semi-Structured Interview of Dentists(Through study completion, an average of 1 year)
- Children's Fear Survey Schedule - Dental Subscale(Collected prior to participant's first dental cleaning)
- Short Sensory Profile(Collected prior to participant's first dental cleaning)
研究者
Leah Stein Duker
Principal Investigator
University of Southern California