experience of dental sedation on assessment before treatment V7
Research type
Research Study
Full title
Effectiveness of experience of nitrous oxide/oxygen sedation at assessment on the dental anxiety of children progressing to treatment under inhalation sedation.
IRAS ID
270932
Contact name
Ioanna Palikaraki
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
The purpose of this study is to find out the effect of experience of dental sedation at assessment on children’s anxiety before the actual treatment session.
The potential participants will be from the waiting list where patients are waiting to receive appointments for dental treatment with the relaxation gas.
The Lead researcher will identify and contact those patients by sending them information sheets about the study through the post at least 2 weeks before the assessment visit.
On the day of the assessment visit we will provide the information sheets and explain the procedures in the waiting room. The informed consent/assent will be also explained and signed.
Following that, eligible participants who have agreed to take part will be randomly assigned to one of two groups. One group will try on the nose piece and the relaxation gas during the assessment appointment before the treatment session while the other group will try the nose piece without the relaxation gas during the assessment appointment.
Participants would be asked to answer some questions about how they feel at the moment (i.e. being at the dentist) at the beginning of the assessment visit and at the beginning and end of the treatment visit. The questions will be asked through a validated questionnaire (MCDASf) (See protocol). Additionally, participants will wear a CE marked wrist band (Empatica E4 wristband (Empatica, Milan, Italy)) similar to a watch throughout both appointments which measures the heart rate and skin temperature.
At the end of the treatment session each participant and his/her parent/legal guardian will be asked to provide some feedback through a short questionnaire (See protocol).REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
20/NW/0157
Date of REC Opinion
16 Jul 2020
REC opinion
Further Information Favourable Opinion