Determining the effect of self-hypnosis on acute pain and delirium in adult patients after coronary bypass surgery
Design
A clinical trial with a control group, without blinding, randomized on 84 patients, the block method was used for randomization.
Settings and conduct
The study is on patients of Shahid Rajaei Heart Institute in Tehran without blinding. The intervention group is self-hypnotized 3 times before surgery. Acute pain and delirium are measured after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age group 18-70;Ability to speak and understand Farsi language
Hypnotizability score > 25 based on the Stanford Form C scale
Elective coronary artery bypass surgery;written consent to participate in the research and telephone follow-up by the researcher
Patient access to smartphone and hands-free; no hearing impairment
RASS = 0 ;GCS = 14;Do not have History of psychiatric disorders: psychosis, severe depression, claustrophobia, acrophobia, obsessive personality, paranoid personality; Do not have a history of seizures and epilepsy
- Exclusion criteria: Surgery is canceled or postponed ، Emergency surgery
Death during surgery ، Refusal to continue studying ; The patient should listen to the hypnosis file less than 3 times ; Receiving continuous intravenous infusion of Dex-medtomidine combined with morphine
Intervention groups
patients of the control group, there is no intervention ; intervention for the case group 48 hours before the surgery: explaining how to do the work, removing any misconceptions about hypnosis, teaching self-hypnosis through the I HYPNOSIS software (author of the work, Dr. Inayat Elah Shahidi) 24 hours before surgery: self-hypnosis by the patient On the morning of surgery (before surgery): self-hypnosis by the patient
Main outcome variables
pain; delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240718062455N1
Registration date:2024-07-30, 1403/05/09
Registration timing:prospective
Last update:2024-07-30, 1403/05/09
Update count:0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Sajede Sajadi
Name of organization / entity
Shaheed rajaie cardiovascular medical and research institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 1498
Email address
sajedesjd2010@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-hypnosis on acute pain and delirium in adult patients after coronary artery bypass surgery
Public title
Effect of self-hypnosis on acute pain and delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak and understand Farsi language
Hypnotizability score of 25 and above based on the Stanford Form C scale
Elective coronary artery bypass surgery
Written consent to participate in the research and telephone follow-up by the researcher
Have no hearing impairment
RASS = 0
GCS =15
Do not have History of psychiatric disorders: psychosis, severe depression, claustrophobia, acrophobia, obsessive personality, paranoid personality
Do not have a history of seizures and epilepsy
Patient access to smartphone and hands-free
Exclusion criteria:
Emergency surgery
Refusal to continue studying
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, balanced block,
Randomization unit: individual
4 permutations of letters AB become six blocks of four.
Opaque envelope sealed with random sequence is used for concealment
Random sequence: Each sequence is placed inside the envelope. The envelopes are placed in the box and opened according to the order in which the participants entered one of the envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Rajaie Cardiovascular, Medical and Research Institute
Street address
No 39, lavasani Ave, Farmanieh
City
Tehran
Province
Tehran
Postal code
1954645386
Approval date
2024-06-15, 1403/03/26
Ethics committee reference number
IR.RHC.REC.1403.034
Health conditions studied
1
Description of health condition studied
Acute pain and delirium after coronary artery bypass surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score based on visual analogue scale
Timepoint
Evaluation of pain 12, 24, 36 and 48 hours after extubation post surgery
Method of measurement
Visual analogue scale
2
Description
Assessment of delirium with Confusion Assessment Method for the Intensive Care Unit
Timepoint
12, 24, 36, 48 hours after surgery
Method of measurement
Confusion Assessment Method for the Intensive Care Unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-hypnosis, using Dr. Inayat Elah Shahidi's self-hypnosis application, 3 times before surgery, 48 and 24 hours and in the morning before surgery, for 20 minutes.
Category
Prevention
2
Description
Control group: there is no intervention by the researcher before surgery, and the patients receive routine care before surgery in the ward.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed rajaie Cardiovascular, Medical & Research institute
Full name of responsible person
Sajede sajadi
Street address
Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute, next to Mellat Park, Wali Asr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
sajedesjd2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
Sajede sajadi
Street address
Niayesh corner of Shahid Rajaei Cardiovascular Educational, Research and Therapeutic Institute, next to Mellat Park, Wali Asr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sajedesjd2010@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaie Cardiovascular, Medical & Research Center
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
Shaheed rajaie cardiovascular, medical & research institute
Full name of responsible person
Sajede sajadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No39, Lavasani Ave, Farmanieh
City
Tehran
Province
Tehran
Postal code
1954645386
Phone
+98 21 2229 1498
Email
sajedesjd2010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed rajaie cardiovascular, medical & research institute
Full name of responsible person
Sajede sajadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 39, Lavasani Ave, Farmanieh
City
Tehran
Province
Tehran
Postal code
1954645386
Phone
+98 21 2229 1498
Email
sajedesjd2010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shaheed rajaie cardiovascular, medical & research institute
Full name of responsible person
Sajede sajadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO 39, Lavasani Ave, Farmanieh
City
Tehran
Province
Tehran
Postal code
1954645386
Phone
+98 21 2229 1498
Email
sajedesjd2010@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data can be shared after other identifiable individuals
When the data will become available and for how long
The access period starts 7 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no restriction on the type of data analysis
The use of documentation is unimpeded by maintaining ethical principles
From where data/document is obtainable
To receive data, send a message to Sajde Sajadi's email
sajedesjd2010@gmail.com
What processes are involved for a request to access data/document
After sending the email, the data will be sent at most one week later