Evaluation and comparison of anxiety levels after using Guided Imagery technique for relaxation and modified Guided Imagery-Hypnotherapy technique in 6 to 14 year-old children undergoing local anesthesia administration.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 2. Salivary Cortisol levels
Study Overview
Brief Summary
Anxiety has been definedas a “vague, unpleasant feeling accompanied by a premonition that somethingundesirable is about to happenâ€. Dental anxiety is driven by a strong negativeor unpleasant emotion towards a dental office or dental procedures. Childrenwith a high level of dental anxiety are more resistant to treatmentand due to this avoidance in dental care can lead toneeding more dental treatments. The quality of a treatment being carriedout, as well as what materials that are to be used, is directly influencedby a child’s level of cooperation and ability to follow instructions. Behaviourmanagement techniques play a major role during all paediatric treatmentprocedures and it is the clinician who is responsible to properly andsafely guide the child’s behaviour. Guided Imagery is a visual andsensory-based complementary and alternative medicine (CAM) technique. Inhypnotherapy which is a type of mind-body intervention; increasedsuggestibility is used in the treatment of a medical or psychological diseaseor condition. Therefore, there is a need of a newer modality based on guided imagery andhypnotherapy to be used in as a whole orin tandem with other conventional behaviour management techniques.
AIM**:**
To evaluate andcompare anxiety levels after using Guided Imagery for relaxation and modifiedGuided Imagery-Hypnotherapy techniques in 6-14 year-old childrenundergoing local anesthesia administration.
METHODOLOGY:
Arandomised control trial will be done among – participants with the age group of 6 to 14 years of age in an isolatedsetup. A total of 45 children are included in the study.
Thestudy participants will be given a set of scripted suggestions to follow forcalming down the anxiety state will be recorded and saliva samples will becollected for measuring pre-and post-intervention salivary cortisollevels.
EXPECTEDRESULTS:
Guided Imagerytechnique and modified Guided Imagery-Hypnotherapy techniquefor relaxation willbe effective in reducing the levels of anxiety in 6-14 year-oldchildren undergoing local anesthesia administration and will show reductionin salivary cortisol levels as well.
KEYWORDS:Guided Imagery, Anxiety, Local Anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children from 6 to 14 years old who are healthy, cooperative but anxious.
- •Children undergoing dental treatment requiring administration of local anesthesia.
Exclusion Criteria
- •Children with past exposure to local anesthesia.
- •Children with a known allergy to local anesthetic agent.
- •Children with psychological abnormalities.
- •Children with special health care needs.
- •Children and parents unwilling to participate.
Outcomes
Primary Outcomes
2. Salivary Cortisol levels
Time Frame: Before and after intervention during L.A. administration
1. Visual Facial Anxiety Scale
Time Frame: Before and after intervention during L.A. administration
Secondary Outcomes
- 1. Pulse rate(2. Oxygen saturation)