Technology-based Distraction Techniques in Managing Children With Attention-deficit/Hyperactivity Disorder

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• Toothache 142

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's enrollment of 48 is below the median of 84 across 123 interventional studies indexed under Toothache.

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Experimental
  Virtual reality glasses

  Behavioral: Virtual reality glasses

• Active comparator
  White noise

  Behavioral: White noise

• Sham comparator
  Basic behavior management techniques

  Behavioral: Basic behavior management techniques

Interventions

• BehavioralVirtual reality glasses

  Children allocated to this group were distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies were shown to the children. The VR glasses were then introduced to the children. The children were given time to accommodate with the device before starting the procedure. The VR glasses were applied during the treatment.

• BehavioralWhite noise

  Wireless kids' headphones were introduced to the children allocated to this group. They were given some time to accommodate with the headphones. Then, the white noise was played and children were asked to concentrate on the music during the procedure. White noise stimulus was set at 70decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise was calibrated using a portable digital sound level meter

• BehavioralBasic behavior management techniques

  Children allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used.

Primary outcomes

1. Pain-related behavior

   Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape.

   Time frame: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.

Secondary outcomes

1. Pulse rate

   The pulse rate was measured using a pulse oximeter. Normal range is considered from 70-110.

   Time frame: The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.

2. Self reported pain

   Self-reported pain was measured using the Wong-Baker FACES rating scale using six cartoon faces, from a broad smile (0, "No Hurt") to a tearful frown (10, "Hurts Worst"), to help children indicate their pain level, with scores increasing by twos (0, 2, 4, 6, 8, 10) to represent mild to severe pain.

   Time frame: The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.

Individual participant data

Plan to share: Yes