Determining the effect of diaphragmatic breathing in reducing anxiety in patients undergoing scaling and root planing
Design
Clinical trial with control group, parallel group, unblinded, block randomization on 60 patients
Settings and conduct
Forty patients aged 20 to 55 years referring to the Department of Periodontology, Yazd Dental School, who meet all the specified inclusion criteria and are candidates for scaling and root planing (SRP) as the first experience, will be selected. Patients will be divided into two intervention and control groups. Intervention group: Training in diaphragmatic breathing and performing diaphragmatic breathing during scaling. Control group: No training or intervention was performed.
Participants/Inclusion and exclusion criteria
Exclusion criteria: No heart or lung disease such as asthma; No smoking; No diagnosed mental health problems such as anxiety or depression; No use of anti-anxiety medications; No pregnancy or breastfeeding, and No chemotherapy; No pain medication; No anxiety medication or antidepressants; No medications that affect heart rate and blood pressure, such as diuretics and beta-blockers; No anticonvulsant medications; No immunosuppressive medications; or No local anesthesia during treatment.
Intervention groups
Intervention group: The group that practiced diaphragmatic breathing during the screening.
Control group: The group that did nothing during the screening.
Studying the effect of diaphragmatic breathing (deep breathing) in reducing anxiety in patients undergoing scaling and root planing treatment
Public title
The effect of diaphragmatic breathing in reducing anxiety in patients undergoing treatment for crime.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 55 years
Need for scaling treatment (with accumulation of local factors and development of Stage II-IV periodontitis)
No previous experience with root canal treatment and root planing
Exclusion criteria:
Not having heart or lung disease such as asthma
No smoking
No diagnosed mental health problems such as anxiety and depression
Not taking anti-anxiety medications
Not pregnant or breastfeeding
Not receiving chemotherapy; receiving painkillers; taking anti-anxiety or antidepressant medications; taking medications that affect heart rate and blood pressure, such as diuretics and beta-blockers; taking anticonvulsants; using immunosuppressant medications; or receiving local anesthesia during treatment
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using the block random allocation method. First, using the PASS 2021 software, we generate a random sequence using the block random allocation method of 15 blocks of 4. The software output is in the form of an Excel file containing a sequence of numbers from one to 60 and a unique code for the research units. Eligible individuals are assigned numbers from one to 60 and are assigned to an intervention group (A or B). The first eligible individual to refer is assigned number 1, the second individual is assigned number 2, and so on, up to 60 patients are assigned to the groups. In order to blind the random assignment of the clients, we seek the help of a third person who is unaware of the interventions and this table is given to him. When the eligible person refers to the study, the third person is asked by voice over the telephone based on the individual number of the intervention group and the individual's assignment to one of the groups is determined and carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry_ Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2025-08-02, 1404/05/11
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1404.030
Health conditions studied
1
Description of health condition studied
Patients with periodontitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Mental anxiety
Timepoint
Before the intervention, after two-thirds of the treatment
Before starting treatment, after completing two-thirds of the treatment
Method of measurement
Pulse oximeter device
2
Description
Blood oxygen
Timepoint
Before starting treatment, after completing two-thirds of the treatment
Method of measurement
Pulse oximeter device
3
Description
Systolic blood pressure
Timepoint
Before starting treatment, after completing two-thirds of the treatment
Method of measurement
Digital sphygmomanometer
4
Description
Diastolic blood pressure
Timepoint
Before starting treatment, after completing two-thirds of the treatment
Method of measurement
Digital sphygmomanometer
5
Description
Satisfaction from treatment
Timepoint
Immediately after treatment
Method of measurement
Ask questions in the questionnaire
Intervention groups
1
Description
Intervention group: In this group, patients are taught diaphragmatic breathing and during treatment, patients are asked to perform diaphragmatic breathing.
Category
Behavior
2
Description
Control group: This group is not given training and does not perform any actions during treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Faculty of Dentistry, Yazd
Full name of responsible person
Fahimeh Rashidi Maybodi
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
f_rashidi63@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Hoshang Mehrparvar
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3623 8506
Email
Ahmehrparvar@ssu.actually.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Zare Mehrjardi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
zahrazare3362@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi Maybodi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
f_rashidi63@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Zare Mehrjerdi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
zahrazare3362@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available