Evaluation of the effect of acupressure in controlling the anxiety of patients before and after inferior alveolar nerve block.
Design
A two-group clinical trial with a control group with randomized parallel groups without blinding is conducted on 75 patients aged 6 to 10 years. Sealed envelopes are used for randomization, including three groups with codes 1, 2 and 3. َAfter opening the envelope, the intervention related to that code is applied to the desired patient.
Settings and conduct
Place of conducting the study: pediatric department of Faculty of Dentistry, Mashhad University of Medical Sciences;
Population: Children aged 6-10 years with dental caries; There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 6 to 10 years; need for dental treatment; Patients who have no history of receiving inferior alveolar nerve block.
Exclusion criteria:
The use of anti-anxiety drugs; emergency patients; patients who receive medication for any chronic disease; patients with chronic systemic disease; patients who have an anxiety disorder or depression; patients who have used acupuncture or acupressure in the last 6 months.
Intervention groups
Intervention group 1: the group that is ready to be treated using acupressure on the tai yang point.
Intervention group 2: the group that is ready to be treated using acupressure on the sham point.
Control group: receiving usual treatments without receiving acupressure.
Main outcome variables
Anxiety score based on Venham scale, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170204032380N2
Registration date:2023-12-17, 1402/09/26
Registration timing:prospective
Last update:2023-12-17, 1402/09/26
Update count:0
Registration date
2023-12-17, 1402/09/26
Registrant information
Name
Maryam Mehrabkhani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
mehrabkhanim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of acupressure in controlling the anxiety of children with dental caries during inferior alveolar nerve block
Public title
The effect of acupressure on anxiety
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 6-10 years old
Need for inferior alveolar nerve block for dental treatment
No history of receiving inferior alveolar nerve block
Exclusion criteria:
Use of anti-anxiety drugs
Use of psychiatric drugs
Emergency patients
Patients who receive medicine for any chronic disease
Chronic systemic disease
Patients who have anxiety disorder or depression
Patients who have used acupuncture or acupressure in the last 6 months
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization through the preparation of sealed envelopes includes three groups corresponding to codes 1, 2 and 3. The envelope selection for each patient is done randomly and after opening the intervention envelope, the corresponding code is applied to the desired patient
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
Research Ethics Committees of School of Dentistry - Mashhad University of Medical Sciences
Street address
Faculty of dentistry- Mashhad university of Medical Sciences - Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1402.061
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score based on the Venham Clinical Anxiety Scale
Timepoint
Before injection of local anesthesia And After injection of local anesthesia
Method of measurement
Venham Clinical Anxiety Rating Scale
Secondary outcomes
1
Description
Heart rate
Timepoint
Before injection of local anesthesia And After injection of local anesthesia
Method of measurement
pulse oximeter
Intervention groups
1
Description
Intervention group 1: The group that is ready to be treated using acupressure on the tai yang point, this point is located between the two eyebrows ( glabella) and can control anxiety. The method of acupressure is using the index finger between the patient's eyebrows, a circular pressure movement is applied for one minute, and then the anesthetic is injected.
Category
Behavior
2
Description
Intervention group 2: This group is ready to be treated using acupressure on the sham point. The Sham point is located in the middle of the mentolabial fold and has no anxiety control properties at all. This point is easy to find and it is in the same area of the face and near the Tai Yang point, and patients do not feel much difference when they communicate with each other procedure is the same as the first intervention group, and applying rotational pressure on the mento-labial fold
Category
Behavior
3
Description
Control group: Children prepared for dental treatment in the usual way (without applying acupressure). In this group, the usual method of local anesthesia injection is performed in such a way that after determining the patient's anxiety level and application of topical anesthesia, injection of anesthetic solution is performed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Mashhad University of Medical Sciences
Full name of responsible person
Maryam Mehrabkhani
Street address
Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor, Qurashi Building, Next to Hoveizeh cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Mehrabkhani
Position
Associate professore
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry; Mashhad University of Medical Sciences Campus; Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Mehrabkhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry; Mashhad University of Medical Sciences Campus; Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of medical sciences
Full name of responsible person
Maryam Mehrabkhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry; Mashhad University of Medical Sciences Campus; Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۵۹
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.ac.ir
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
Not applicable
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