CTRI Number	CTRI/2022/09/045238 [Registered on: 06/09/2022] Trial Registered Prospectively
Last Modified On:	19/03/2024
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Behavioral
Study Design	Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study	Effectiveness of guided imagery and modified guided imagery in reduction of anxiety in children
Scientific Title of Study	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.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Himani Parakh  Address  Department number 302, Pediatric and Preventive Dentistry, SPDC, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India  Phone  8149444744   Fax     Email  himaniparakh08@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Nilima Thosar  Address  Department number 302, Pediatric and Preventive Dentistry, SPDC, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India  Phone  9422163632   Fax     Email  drnthosar@rediffmail.com
Details Contact Person Public Query Modification(s)	Name  Himani Parakh  Address  Department number 302, Pediatric and Preventive Dentistry, SPDC, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India  Phone  8149444744   Fax     Email  himaniparakh08@gmail.com
Source of Monetary or Material Support Modification(s)	Sharad Pawar Dental College And Hospital, Sawangi (Meghe), Wardha
Primary Sponsor Modification(s)	Name  Sharad Pawar Dental College And Hospital  Address  Department number 302, Pediatric and Preventive Dentistry, SPDC, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Himani Parakh  Sharad Pawar Dental College And Hospital  Department number 302, Pediatric and Preventive Dentistry, SPDC, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha Wardha   8149444744 himaniparakh08@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  INSTITUTIONAL ETHICS COMMITTEE  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Anxious children
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Guided Imagery Technique  Guided Imagery Technique in anxiety reduction during L.A. administration in 6 to 14-year-olds  Intervention  Modified Guided Imagery Technique  Modified Guided Imagery Technique for reduction of anxiety during L.A administration in 6 to 14 year olds
Inclusion Criteria	Age From  6.00 Year(s) Age To  14.00 Year(s) Gender  Both  Details  Children from 6 to 14 years old who are healthy, cooperative but anxious. Children undergoing dental treatment requiring administration of local anesthesia.
ExclusionCriteria	Details  1. Children with past exposure to local anesthesia. 2. Children with a known allergy to local anesthetic agent. 3. Children with psychological abnormalities. 4. Children with special health care needs. 5. Children suffering from systemic diseases. 6. Children and parents unwilling to participate.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	On-site computer system
Blinding/Masking	Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome	Outcome  TimePoints  1. Visual Facial Anxiety Scale 2. Salivary Cortisol levels  Before and after intervention during L.A. administration
Secondary Outcome	Outcome  TimePoints  1. Pulse rate 2. Oxygen saturation  Before and after intervention during L.A. administration
Target Sample Size Modification(s)	Total Sample Size="45" Sample Size from India="45"
Phase of Trial Modification(s)	Phase 2/ Phase 3
Date of First Enrollment (India)	08/09/2022
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Closed to Recruitment of Participants
Publication Details Modification(s)	none yet
Brief Summary	Anxiety has been defined as a “vague, unpleasant feeling accompanied by a premonition that something undesirable is about to happen”. Dental anxiety is driven by a strong negative or unpleasant emotion towards a dental office or dental procedures. Children with a high level of dental anxiety are more resistant to treatment and due to this avoidance in dental care can lead to needing more dental treatments. The quality of a treatment being carried out, as well as what materials that are to be used, is directly influenced by a child’s level of cooperation and ability to follow instructions. Behaviour management techniques play a major role during all paediatric treatment procedures and it is the clinician who is responsible to properly and safely guide the child’s behaviour. Guided Imagery is a visual and sensory-based complementary and alternative medicine (CAM) technique. In hypnotherapy which is a type of mind-body intervention; increased suggestibility is used in the treatment of a medical or psychological disease or condition. Therefore, there is a need of a newer modality based on guided imagery and hypnotherapy to be used in as a whole or in tandem with other conventional behaviour management techniques. AIM: To evaluate and compare anxiety levels after using Guided Imagery for relaxation and modified Guided Imagery-Hypnotherapy techniques in 6-14 year-old children undergoing local anesthesia administration.   METHODOLOGY: A randomised control trial will be done among – participants with the age group of 6 to 14 years of age in an isolated setup. A total of 45 children are included in the study. The study participants will be given a set of scripted suggestions to follow for calming down the anxiety state will be recorded and saliva samples will be collected for measuring pre-and post-intervention salivary cortisol levels.   EXPECTED RESULTS: Guided Imagery technique and modified Guided Imagery-Hypnotherapy technique for relaxation will be effective in reducing the levels of anxiety in 6-14 year-old children undergoing local anesthesia administration and will show reduction in salivary cortisol levels as well.    KEYWORDS: Guided Imagery, Anxiety, Local Anesthesia.