NCT07859267

Brief Summary

The goal of this randomized controlled clinical trial is to evaluate whether a brief preoperative video-guided breathing exercise reduces postoperative pain in adults undergoing single-visit root canal treatment for symptomatic irreversible pulpitis. The main questions it aims to answer are:

  • Does a 2-minute video-guided breathing exercise reduce postoperative pain 24 hours after root canal treatment compared with a 2-minute period of passive rest?
  • Does the breathing exercise affect pain experienced during root canal treatment or postoperative pain at 6, 12, 48, and 72 hours?
  • Does the breathing exercise reduce the need for supplemental local anesthesia during treatment?
  • Does the breathing exercise reduce analgesic use during the first 72 hours after treatment?
  • Does the breathing exercise produce a greater immediate change in heart rate compared with passive rest? Participants will be randomly assigned to one of two groups before root canal treatment. In the video-guided breathing exercise group, participants will watch a standardized 2-minute video and follow a controlled breathing pattern consisting of inhaling through the nose for 4 seconds followed by exhaling for 6 seconds. This breathing cycle will be repeated throughout the video. In the passive rest group, participants will remain seated in the dental chair for 2 minutes without receiving any breathing or relaxation instructions and will be asked to breathe normally. All participants will then receive single-visit root canal treatment using the same standardized endodontic treatment protocol. Postoperative pain will be assessed at 6, 12, 24, 48, and 72 hours after treatment. Pain at 24 hours will be the primary outcome. Maximum pain experienced during treatment, supplemental anesthesia requirement, analgesic use during the first 72 hours, and change in heart rate immediately before and after the assigned preoperative intervention will also be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2026

Completed
Last Updated

October 19, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 29, 2026

Last Update Submit

October 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain at 24 Hours

    Postoperative pain intensity will be assessed 24 hours after single-visit root canal treatment using a 10-cm visual analog scale (VAS), with 0 representing "no pain" and 10 representing "the worst imaginable pain."

    24 hours after root canal treatment

Study Arms (2)

Video-Guided Breathing Exercise

EXPERIMENTAL

Participants will perform a standardized 2-minute video-guided breathing exercise before root canal treatment. They will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds, repeating this breathing cycle throughout the video.

Behavioral: Video-Guided Breathing Exercise

Passive Rest

NO INTERVENTION

Participants will remain seated in the dental chair for 2 minutes before root canal treatment without receiving any breathing or relaxation instructions. They will be asked to continue breathing naturally during this period.

Interventions

Participants assigned to the intervention group will perform a standardized 2-minute video-guided breathing exercise immediately before root canal treatment. During the exercise, participants will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds. This breathing cycle will be repeated throughout the 2-minute video. The same video will be used for all participants to standardize the instructions and duration of the intervention.

Video-Guided Breathing Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Presence of preoperative pain in the tooth to be treated
  • Diagnosis of symptomatic irreversible pulpitis
  • Positive response to thermal and electric pulp sensitivity tests
  • No periapical radiolucent lesion on periapical radiography
  • Indication for primary root canal treatment
  • Root canal treatment planned to be completed in a single visit
  • Only one tooth included per participant

You may not qualify if:

  • Previous root canal treatment in the tooth to be treated
  • Presence of acute apical abscess
  • Presence of a periapical radiolucent lesion
  • Pulp necrosis
  • Use of analgesic medication within 24 hours before treatment
  • ASA physical status III or higher
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (1)

  • Verma MR, Rao RD, Langade D, Jain AK, Guha A, Mohan M. Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study. J Conserv Dent. 2021 Mar-Apr;24(2):209-213. doi: 10.4103/jcd.jcd_97_21. Epub 2021 Oct 9.

    PMID: 34759592BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 5, 2026

Study Start

May 9, 2026

Primary Completion

September 10, 2026

Study Completion

September 25, 2026

Last Updated

October 19, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations