Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.

Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Behavioral: Muscle Relaxation

Detailed Description

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nouran Khalifa; Phone Number: +201091694444; Email: nouran.khalifa@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rasha Adel; Phone Number: +201007505888; Email: rashaadelragab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children: 6 to 9 years old ADHD children
• Teeth: Teeth requiring dental treatment or preventive measure.

Exclusion Criteria:

• Non ADHD children.
• ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
• Refusal of participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD Group; Muscle Relaxation technique for behavioral management	Behavioral: Muscle Relaxation; Ask the child to lie down in a comfortable position. Ask him/her to notice how their muscles feel in each part of the body. Taking one area of the body at a time (face, shoulders, arms, hands, fingers, abdomen, legs, feet, and toes).; Instruct the child to contract the muscles for 5 seconds, take a deep breath, and release.; Next, instruct the child to contract all muscles simultaneously, hold for 5 seconds, then release.; Finally, ask him/her to notice how his/her muscles feel after the exercise.; Other Names: Relaxation technique
No Intervention: Tell Show Do Group; Tell Show Do Technique for behavioral management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Frankl Scale for child cooperation	Rating 1: DEFINITLY NEGATIVE (--): Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism.; Rating 2: NEGATIVE (-): Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, i.e. sullen, withdrawn.; Rating 3: NEGATIVE POSITIVE (-+): Fluctuation between uncooperativeness and some evidence of unpronounced negative attitude, and cautious acceptance to treatment with reservation shifting throughout the visit.; Rating 4: POSITIVE (+): Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively.; Rating 5: DEFINITLY POSITIVE (++): Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of treatment	weather the dental treatment completed or not	one day

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ADHD; behavioral management; dental management
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 14422016457337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data, information, participant's personal information, family history, social and medical history will be stored in the files assigned to each patient with limited access to minimum number of individuals necessary for quality control, audit, and analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No