Determining the effect of Benson sedation on the severity of headache caused by intravenous nitroglycerin infusion.
Design
The present study is a parallel-group randomized controlled clinical trial. Eligible patients are divided into two groups of 30: intervention and control.
Settings and conduct
For the intervention group, the relaxation method will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A new diagnosis of ACS, Age above 18 years, No migraine headaches and any other headaches, No drug addiction, Absence of neurological disorders under drug treatment, Absence of headache before starting nitroglycerin injection, Absence of pain in other parts of the body (except chest pain),Absence of speech and vision disorders, Not using oral and topical nitrate drugs
Exclusion criteria: Non-cooperation due to increased chest pain and worsening of the patient's hemodynamic symptoms, need to increase the dose of nitroglycerin (more than 5 micrograms per minute), and non-cooperation with the researcher.
Intervention groups
For the intervention group, the relaxation method will be performed. This intervention will be performed after 5 minutes of teaching the patient how to do deep breathing for 15 minutes in the presence and with the help of a nurse. Intravenous nitroglycerin infusion will be performed at a dose of 5 micrograms per minute and a rate of 6 drops per minute.
Main outcome variables
Benson's Relaxation
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N47
Registration date:2025-05-14, 1404/02/24
Registration timing:registered_while_recruiting
Last update:2025-05-14, 1404/02/24
Update count:0
Registration date
2025-05-14, 1404/02/24
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-25, 1404/01/05
Expected recruitment end date
2025-06-26, 1404/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson's relaxation on range of headache-induced by intravenous infusion of nitroglycerin in acute coronary syndrome patients
Public title
Effect of Benson's sedation on nitroglycerin-induced headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A new diagnosis of ACS
Age above 18 years
No migraine headaches and any other headaches
No drug addiction
Absence of neurological disorders under drug treatment
Absence of headache before starting nitroglycerin injection
Absence of pain in other parts of the body (except chest pain)
Absence of speech and vision disorders
Not using oral and topical nitrate drugs
Exclusion criteria:
Lack of ability due to increased chest pain and confusion of the patient's hemodynamic symptoms (sbp<100, p<60)
The need to increase the dose of nitroglycerin received (more than 5 micrograms per minute)
Lack of cooperation with the researcher
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done in an accessible manner. And based on statistical software, permuted block randomization method, random allocation is done in each group and 15 blocks of 4 are designed. So that 2 cards A and 2 cards B are placed in each block. 60 envelopes with lids with numbers 1-60 are inserted. A and B cards are placed inside the envelopes based on the numbers of the software, and based on the date of admission of the patients to the department, the envelopes are opened in order of number and the patients enter the study.
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2025-01-01, 1403/10/12
Ethics committee reference number
IR.MAZUMS.REC.1403.490
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I24.0
ICD-10 code description
Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
Description
Pain
Timepoint
For both the intervention and control groups, The first headache measurement will be done 15 minutes after the start of intravenous nitroglycerin infusion (before the intervention). The second measurement of headache will be done 35 minutes after the start of intravenous nitroglycerin infusion (immediately after the end of sedation) and the third measurement of headache will be done 60 minutes after the start of intravenous nitroglycerin infusion (after the intervention).
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, the sedation method will be performed by the researcher on the bed in Fatemeh Zahra Hospital in Sari. This intervention will be performed for 15 minutes in the presence and with the help of a nurse after 5 minutes of teaching the patient how to take deep breaths. (After 15 minutes of starting the nitroglycerin infusion, 5 minutes of deep breathing training will be given, in other words, the intervention will be performed 20 minutes after starting the intravenous nitroglycerin infusion.) Intravenous nitroglycerin infusion will be performed at a dose of 5 micrograms per minute and a rate of 6 drops per minute (27); so that the intervention group will receive sedation despite the standard treatment (injection of one gram of intravenous acetaminophen or Apotel) (9).
Category
Treatment - Other
2
Description
Control group: The control group will receive the same dose of 5 micrograms per minute intravenous nitroglycerin infusion and, in the event of headache, the same protocol for treating headache caused by intravenous nitroglycerin infusion, which is an intravenous injection of 1 gram of acetaminophen, will be used (9); however, they will not receive any sedative intervention. Headache measurements in the control group will be performed similarly to those in the intervention group at 15, 35, and 60 minutes after the start of the intravenous nitroglycerin infusion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Masoumeh Bagheri Nessami
Street address
Moalem street
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
anna3043@gmail
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Professor Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences,Valiye asar highway , Joybar 3 way ,Imam sq
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3397 8055
Email
anna3043@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran Mideacal Science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sar
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
anna3043@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Phd in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
ann3043@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
anna3043@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD