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

May 15, 2019 updated by: Nouran Khalifa Hamed, Cairo University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: one day

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
Time Frame: one day
weather the dental treatment completed or not
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe