Comparison of the Effect of Adjunctive Guided Imagery and Hypnotherapy on Stress, Pain and Success of Inferior Alveolar Nerve Block Anesthesia Related to Root canal Treatment of Teeth With Irreversible Pulpitis
This study evaluates the effect of Guided Imagery and Adjunctive hypnotherapy on stress, pain and success of anesthesia in teeth with Irreversible Pulpitis. Among the key inclusion criteria are complete mental health, no history of drug use during the last 24 hours and capability to comprehend and fill out the forms.Form the key exclusion criteria are Pregnancy, lactation, low hypnotizability and multiple sclerosis. The study group is composed of teeth with irreversible pulpitis and sample size is 120 patients ( three 40-person groups). Stress is assessed using Corah form and pain and success of anesthesia are assessed with VAS form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082814513N1
Registration date:2013-09-19, 1392/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-19, 1392/06/28
Registrant information
Name
Mohsen Ramazani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1340 5474
Email address
m.ramazani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-11-10, 1391/08/20
Expected recruitment end date
2013-12-10, 1392/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Adjunctive Guided Imagery and Hypnotherapy on Stress, Pain and Success of Inferior Alveolar Nerve Block Anesthesia Related to Root canal Treatment of Teeth With Irreversible Pulpitis
Public title
The effect of Hypnosis on stress, Pain, and success of Anesthesia when Performing Root Canal Therapy for Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Approval of irreversible pulpitis; Age between 13 and 60; Hypnotizability of patients; no drug usage, at least during the last 24 hours; Pain intensity more than 54 upon VAS; Capability of reading and comprehending the VAS form; Filling out the consent form
Exclusion: Any medical disorder; Pregnancy or lactation; Allergy to Ibuprofen; Multiple Sclerosis
Age
From 13 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Deputy of Reasearch and Technology- Sari- Iran
City
Sari
Postal code
4816995475
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
9221
Health conditions studied
1
Description of health condition studied
Diseases of pulp and periapical tissues
ICD-10 code
K04.4
ICD-10 code description
Irreversible Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
4, 8, 12, 24, 48, and 72 hours after completion of root canal therapy
Method of measurement
using VAS form
Secondary outcomes
1
Description
Stress
Timepoint
Before and After Root canal Therapy
Method of measurement
using Corah questionaree
Intervention groups
1
Description
Control: Without any other intervention, the routine root canal therapy is done.
Category
Behavior
2
Description
Guided Imagery: From 30 minutes prior to treatment commence the patients are wanted to imagine upon the therapists inductions while listening to the trance background music.
Category
Behavior
3
Description
Adjunctive Hypnotherapy: The patients are fallen into hypnotic situation 30 minutes prior to treatment commence while listening the relaxing music.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Dental School
Full name of responsible person
Dr Mohsen Ramazani, Associate Professor of Endodontics, and Hypnotherapist
Street address
Tooba Comples- Khazar Blv.- Sar-Iiran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohsen Ramazani
Street address
Sari Dental School- Khazar Blv.- Sari- Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohsen Ramazani
Position
Associate Professor of Endodontics- Hypnotherapist
Other areas of specialty/work
Street address
Endodontics Dep.- Sari Dental School- Khazar Blv.- Sari- iran
City
Sari
Postal code
4816995475
Phone
+98 15 1340 5474
Fax
+98 15 1324 4894
Email
m.ramazani@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandarsn University of Medical Sciences
Full name of responsible person
Dr Mohsen Ramazani
Position
Associate Professor of Endodontics- Hypnotherapist
Other areas of specialty/work
Street address
Endodontics Dep.- Sari Dental School- Sari- Iran
City
Sari
Postal code
4816995475
Phone
+98 15 1340 5474
Fax
+98 15 1324 4894
Email
m.ramazani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohsen Ramazani
Position
Associate Professor of Endodontics- Hypnotherapist
Other areas of specialty/work
Street address
Endodontics Dep.- Khazar Blv.- Sari- Iran
City
Sari
Postal code
4816995475
Phone
+98 15 1340 5474
Fax
+98 15 1324 4894
Email
m.ramazani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)