Ear Plugs Versus Acupressure for Management of Severe Gag Reflex

Ear Plugs Versus Acupressure for Management of Severe Gag Reflex: A Randomized Clinical Trial

The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques: the ear plug technique and acupressure on the P6 point in reducing gag reflex during impression making and to assess patient's experience in terms of comfort and satisfaction.

Study Overview

• Status: Unknown
• Conditions: Gagging
• Intervention / Treatment: Other: Earplugs; Other: Acupressure; Other: Placebo

Detailed Description

The study will take place at the clinics of Riyadh Colleges of Dentistry and Pharmacy (RCsDP) in Riyadh, Saudi Arabia.

Patients, who on previous occasions have demonstrated difficulties in accepting the procedure of making impressions of maxillary teeth due to a severe gag reflex (GR) will be invited to participate in the study.

A Randomized single blinded clinical trial will be conducted on 30 participants who fulfill the inclusion criteria. Participants will be assigned to three separate groups. For each patient, two maxillary alginate impressions will be made; one before applying the proposed management technique and one after. Participants of Group EP (n=10) will be managed using earplugs while Group AC (n=10) will be managed using acupressure band and Group PL (n=10) will receive placebo management in forms of regular bands.

Informed consent will be obtained from all participants. All impressions will be made by one dentist that will be blinded to the gag reflex (GR) management techniques. The GR evaluation for all the participants will be performed by another calibrated dentist who is also blinded to the applied technique.

The severity of gag reflex will be assessed during making of the first impression using Dickinson & Fiske (2005) gagging severity index (GSI).

After 20 minutes of making the first impression, participants of Group EP will be asked to place the earplugs in and wait in the waiting room for 10 minutes. Then, the second impression will be made while the participant still has the earplugs on. Group AC will have acupressure technique via sea aid bands which will be placed on the P6 points of both hand wrists. Participants will be asked to wait in the waiting room for 10 minutes then the second impression will be made. PL Group will have the placebo management via placebo bands ( with no pressure points ) which will be placed on both hand wrists. Participants will also be asked to wait in the waiting room for 10 minutes then the second impression will be made. The effectiveness of the treatment will be assessed using Dickinson & Fiske (2005) gagging prevention index (GPI).

Participants will be asked to rate their discomfort during impression making using visual analogue scale (VAS).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11681
    • Recruiting
    • Riyadh Colleges of Dentistry and Pharmacy
    • Contact: Mohammad R Rayyan, master; Phone Number: 00966508821318; Email: dr_rayyan@riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The individual is able to give informed consent.
• Patients with GR severity that are assigned to a gagging severity index (GSI) III-IV (for standardization of the baseline severity in between Groups).

Exclusion Criteria:

• Pregnant women
• Patients with Chronic heart diseases or cardiac pacemakers
• Patients with central or peripheral nervous system disorders
• Patients with oral lesions
• Patients with gastrointestinal disorders.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Earplugs; The participant will be asked to put plastic earplugs in both ears for 10 minutes and then the impression will be made while they are still on.	Other: Earplugs; Plastic earplugs on both ears
Experimental: Acupressure; The participant will be asked to wear sea bands on P6 points of both hand wrists for 10 minutes and then the impression will be made while they are still on.	Other: Acupressure; Sea Bands put on the wrists of the participant to apply pressure on P6 points
Placebo Comparator: Placebo; The participant will be asked to wear non pressure bands on both hand wrists for 10 minutes and then the impression will be made while they are still on.	Other: Placebo; Non pressure bands put on the wrists of the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Gagging severity index score	Gagging severity index (GSI) is a scale of gagging severity which ranges from 1 to 5 (very mild to very severe)	At the time of first impression which is made before applying the intervention method (baseline score) and again at the time of the second impression which is made after application of the intervention method by 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Visual Analogue Scale scoring of patient's satisfaction during impression making	The participant will be asked to score their judgment of the impression experience on a 0-10 scale where 0 refers to extremely pleasant and 10 refers to extremely unpleasant	Directly after first impression which is made before applying the intervention (baseline score) and directly after the second impression which is made after application of the intervention method by 10 minutes

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Mohammad R Rayyan, master, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Gagging
• Other Study ID Numbers: FUGRP/2016/115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided