Symptomatic Irreversible PulpitisNCT07859267
Effect of Preoperative Video-Guided Breathing on Pain in Symptomatic Irreversible Pulpitis
A study testing Video-Guided Breathing Exercise in people with Symptomatic Irreversible Pulpitis and Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Postoperative Pain
- What is being tested?
- Video-Guided Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2026to 25 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Indication for primary root canal treatment
- Root canal treatment planned to be completed in a single visit
- Only one tooth included per participant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Two-Minute Preoperative Video-Guided Breathing Exercise on Intraoperative and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial
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:
Read more
- 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.
- Being tested
- Video-Guided Breathing Exercise
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Guided Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 24 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start9 May 2026
- Primary completion10 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859267
- Sponsor's protocol ID
- 08.05.2026/166
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34759592