To determine the effect of hypnosis on pain relief due to injection of dental infiltration anesthesia
Design
Two arm parallel group randomized clinical trial with double blinding (dentist & the person who record the data) and participation of 32 patients
Settings and conduct
The study will be conducted at Dentistry School affiliated to Kurdistan University of Medical Sciences.
The study will be double blind (Dentist & the person who record the data).
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 15 and 25 years old; in need of double-sided restoration process of the first premolar teeth in the maxilla; ASAl,ll. Non inclusion criteria: patients with heart problems, untreated epilepsy, patients with severe psychiatric disorders; low intelligence quotient (IQ)
Intervention groups
First intervention group: In the first session, first hypnosis is received and then the injection is performed, and in the second session on the other side of the jaw, the injection is received without hypnosis.
Second intervention group: In the first session, injection is performed on one side of the jaw without hypnosis, and in the second session, first hypnosis and then injection on the other side of the jaw are performed.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140504017562N3
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Soma Arabzadeh Moghadam
Name of organization / entity
Kurdestan Univercity of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 71 3654 1094
Email address
arabzade_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-29, 1398/09/08
Expected recruitment end date
2020-06-01, 1399/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypnosis in pain reduction during dental anesthetetic infiltration
Public title
The effect of hypnosis in pain reduction during dental injection
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers who needed to receive restorative dentistry in the maxillary right and left first premolar teeth;
ASA class l & ll
Exclusion criteria:
Volunteers with heart problems
Untreated epilepsy
Severe psychiatric disorders
Low IQ
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
Each person participating in the study is placed in a control group in one session and in another session in the intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method: patients are randomly allocated to either the intervention group A or control group B, it means that the first patient accidentally falls into one of the groups and the next patient falls into another group. This will continue until the study is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding method: The dentist who injects the anesthesia and the person who records the data are not present at the operating room while hypnosis is performed and they do not know which volunteer receives hypnosis.
Placebo
Not used
Assignment
Crossover
Other design features
Each participant in the study is placed in a control group in one session and in the next session in the intervention group, or vice versa. the intervention session and side of the maxilla is chosen randomly
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Approval date
2018-07-17, 1397/04/26
Ethics committee reference number
IR.MUK.REC.1397.018
Health conditions studied
1
Description of health condition studied
The effect of hypnosis in pain reduction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score based on Visual Analogue Scale
Timepoint
Immediately after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, injection is performed with the same method and materials and equipment of the control group, along with hypnosis. A hypnosis's session is used to reduce the pain of the patients being studied and indirect induction techniques, dissociated techniques, telescopes and distraction are used. Also the duration of hypnosis varies from one person to another persons, because the hypnotic nature of the person varies from a few minutes to an hour.
Category
Diagnosis
2
Description
Control group: Injection without hypnosis
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Kurdistan University of Medical Sciences
Full name of responsible person
Soma Arabzade Moghadam
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3666 4658
Email
s.arabzade@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3666 4658
Email
S.arabzade@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Soma Arabzade Moghadam
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3666 4658
Email
S_arabzade@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soma Arabzade Moghadam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3666 4658
Email
S.arabzade@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soma Arabzade Moghadam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran boulevard
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3666 4658
Fax
Email
S.arabzade@muk.ac.ir
Sharing plan
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data included
1- The age of the participants and their gender
2. The number of pain felt by the participants
3. Hypnosis method
When the data will become available and for how long
4 month after printing the article
To whom data/document is available
All researchers in the field of psychology and dentistry
Under which criteria data/document could be used
To research the subject of study
From where data/document is obtainable
Email to Dr. Fayegh yousefi via fykmsu@gmail.com
Dr. Soma Arabzadeh Moghadam via s.arabzade@muk.ac.ir
What processes are involved for a request to access data/document
1. Send emails to people who have been identified.
2. Review the request by the individuals who have been identified.
3- Permission to access the data if you have the conditions (maximum 14 days from the time of sending the email )