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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03951155
• Other study ID #: 14422016457337
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Cairo University
• Contact: Nouran Khalifa
• Phone: +201091694444
• Email: nouran.khalifa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of treatment	weather the dental treatment completed or not	one day