Efficacy and Safety of HFNC for Stress Reduction during Dental Treatment

JRCT ID: jRCTs072240099

Registered date:21/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Caries
• Date of first enrollment: 21/01/2025
• Target sample size: 30
• Study type: Interventional
• Intervention(s): After obtaining consent, on the first treatment day, dental treatment (mechanical tartar removal) is performed under conventional methods without nasal cannula, etc., and the patient is asked to fill out the questionnaire afterwards. A second treatment is planned at least one week after the first measurement.

Outcome(s)

Primary Outcome

1) Pulse and respiratory rate during treatment (continuous measurement by AIRVO3)
2) Evaluation of parasympathetic activation (rate of change of LH/HF) from RR interval analysis of ECG
3) Evaluation of stress from the rate of appearance of alpha waves in the EEG will also be performed.

Secondary Outcome

Secondary endpoints include the comfort of dental treatment (evaluation of 9 questions) to compare the first and second
Comparison of the first and second sessions
Please rate the following questions on a 5-point scale.
1: Not at all, 2: A little, 3: Somewhat, 4: Quite a bit, 5: Very much

Q1: During the treatment, did you feel stiff?
Q2: Did you breathe faster during the treatment?
Q3: Did you sweat during the treatment?
Q4: Did you feel sick or nauseous during treatment?
Q5: Did your heart beat faster during treatment?
Q6: Did you find it easy to breathe through your nose during treatment?
Q7: During treatment, were you able to swallow the rest of your saliva or water?
Q8: Did you feel anxious during treatment?
Q9: If you had to use the treatment again, which method would you prefer to use, the first or the second? (Only administered at the end of the second session)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients who visit the Nagasaki University Hospital Dental Division for mechanical tartar removal on the left and right sides (upper and lower jaws) on two or more separate occasions.
2)Age: Adult patients who are at least 18 years old at the time of consent.
3)Gender: Any gender
4)Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclude criteria

1)Patients with cognitive impairment who are unable to respond to the questionnaire survey on their own
2) Patients who cannot breathe through the nose
3)Pregnant patients
4)Other patients deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Ayuse Terumi
• Source(s) of Monetary Support: Fisher& Paykel(Fisher & Paykel Healthcare Limited)