The effect of breathing exercise using bubble blower on anxiety, behaviour and pain during inferior alveolar nerve block in children aged 7 to 10 years
Evaluation of the effect of breathing exercise using bubble blower on anxiety, behaviour and pain during inferior alveolar nerve block in children aged 7 to 10 years.
Design
Clinical trial with cross over design, with simple randomization without blinding with a sample size of 40
Settings and conduct
The study comprises two groups: 1 and 2; in the group 1 the breathing exercise is started a week before the the first pulp therapy visit, also it is used immediately before and during the injection. in the second visit the routine injection is done.
in the group 2; in the first pulp therapy visit the routine injection is done. but the breathing exercise is started a week before the the second pulp therapy visit, also it is used immediately before and during the injection.
Each group is divided to two subgroups : A and B; in the subgroup A right mandibular quadrant is treated in the first pulp therapy visit and left mandibular quadrant is treated in the second pulp therapy visit. it will be the opposite in the subgroup B.
Participants/Inclusion and exclusion criteria
Children with grade 3,4 or 5 of FIS who require bilateral pulp therapy of mandibular primary molars
Intervention groups
1. Control Group: routinely inferior alveolar nerve block with topical anaesthetic gel
2. Intervention group: inferior alveolar nerve block with topical anaesthetic gel and breathing exercise during injection.
in this exercise, the child must inhale deep breaths from the stomach and slowly exhale into a commercial bubble blower to make a big bubble.
this exercise must be done 4-5 times a day one week before the pulp therapy using the bubble blower. it is repeated 4 times before the injection with the toy and during the injection without.
Main outcome variables
Anxiety ; Pain ; Behaviour
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044953N2
Registration date:2020-06-03, 1399/03/14
Registration timing:prospective
Last update:2020-06-03, 1399/03/14
Update count:0
Registration date
2020-06-03, 1399/03/14
Registrant information
Name
Nahid Maghsoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 1631
Email address
nahidmaghsoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-28, 1399/07/07
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing exercise using bubble blower on anxiety, behaviour and pain during inferior alveolar nerve block in children aged 7 to 10 years
Public title
The effect of breathing exercise using bubble blower on anxiety, behaviour and pain during mandibular anaesthesia injection in children aged 7 to 10 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children without any history of local anaesthestic drugs allergy or learning disabilities
Children with grade 3,4 or 5 of FIS who require bilateral pulp therapy of mandibular primary molars
Children with capable of communication in Farsi
Children not requiring emergency treatment
Children without major psychologic disorders like Seperation Anxiety Disorder, General Anxiety Disorder and Obsessive-Compulsive Disorder
Exclusion criteria:
Necrotic teeth
Parental uncooperation
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient consists of two samples which are right and left mandibular quadrants.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple. Randomization unit: mandibular quadrant . Randomization tool: Statistical Software. For allocation concealment, the numbers in the software list are separately put into envelopes. For each patient in the first visit, a sealed envelop is used to determine whether the breathing exercise is going to be used in the first or second pulp therapy visit. Another sealed envelop is used in the first pulp therapy visit to determine the first quadrant(left or right) undergoing treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
In the begining of the study in the first visit, also in both pulp therapy visits before the anasthesia injection.
Method of measurement
Facial Image Scale
Secondary outcomes
1
Description
Pulse rate
Timepoint
5 minutes before and after and during anaesthesia injection in pulp therapy visits
Method of measurement
Pulse rare measurement
2
Description
Pain
Timepoint
Immediately after anaesthesia injection in pulp therapy visits
Method of measurement
Subjective evaluation using Wong Baker Facial Pain Scale
3
Description
Pain
Timepoint
During anaesthesia injection in pulp therapy visits
Method of measurement
Objective evaluation using Face Leg Activity Cry Consolobility Scale
4
Description
Behaviour
Timepoint
During anaesthesia injection in pulp therapy visits
Method of measurement
Objective evaluation using Frankl Behaviour Rating Scale
Intervention groups
1
Description
Intervention group: practising the breathing exercise one week before the pulp therapy with bubble blower, four times practice before the injection and repeating the exercise during injection(without blower)
Category
Treatment - Other
2
Description
Control group: Routinely inferior alveolar nerve block injection using topical anaesthetic gel.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Undetectable information such as age, sex and previous dental treatments history will be published. Study outcomes will also be published, including changes in pulse rate and data regarding Facial Image Scale, Wong-Baker Facial Pain Scale, Face Leg Activity Cry Consolability Scale and Frankle behaviour rating scale .
When the data will become available and for how long
9 months after publication
To whom data/document is available
The data are only available for investigators working in academic and scientific institutions.
Under which criteria data/document could be used
Use of this data is permitted for systematic review and meta-analysis. Similar clinical trials can also use the data to criticize the present study and its results in their Discussion.
From where data/document is obtainable
1. Send an email to nahidmaghsoodi@yahoo.com 2. Send an email to zbahrololoom@yahoo.com 3. Telephone Call with Dr. Zahra Bahrololoomi, No. 983536214257.
What processes are involved for a request to access data/document
After the request via one of the three methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month.