Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children

Not Applicable

Recruiting

• Conditions: Gagging
• Interventions: Device: low-level laser; Device: placebo; Biological: microcurrent stimulation

• Registration Number: NCT06422286
• Lead Sponsor: Alexandria University

Brief Summary

the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children

Detailed Description

the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared.

Study Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-04-24
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-18
• Last Update Submitted: 2024-05-18
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-08-16
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• children free of any systemic disease or special health care needs
• children with score 2 or 3 according to the frankle behavioral rating scale
• a full arch maxillary alginate impression is needed
• moderate to severe gagging according to the gagging severity index
• written informed consent of the legal guardian

Exclusion Criteria

• children taking anti-emetic drugs
• children sensitive to alginate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
children allocated to low-level laser	low-level laser	The laser device with wavelength 940 nm, energy 4J, and 3-4 mm away from the tissue is applied on PC6 acupoint without causing pain to the patient for 1 minute. Immediately after the laser acupuncture, an alginate impression is going to be taken.
placebo control group	placebo	A meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken.
children allocated to microcurrent electrical stimulation	microcurrent stimulation	A meridian acupuncture pen with AA battery will be applied on PC6 for one minute. Immediately after using the meridian pen, an alginate impression is going to be taken.

Primary Outcome Measures

Name	Time	Method
gagging prevetive index	immediately after the intervention	the difference in gagging preventive index before and after the intervention

Secondary Outcome Measures

Name	Time	Method
anxiety	immediately after the intervention	dental anxiety will be measured before and after the intervention using pulse oximeter

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt