Determining the effect of acupressure on the amount of pain, restlessness and the use of sedatives in patients under mechanical ventilation
Design
In this phase one clinical trial, which is conducted in parallel, 60 patients under mechanical ventilation are divided into two intervention and control groups by block randomization method using R statistical software. It is not possible to blind the groups in this study.
Settings and conduct
This study is carried out in the critical care units of Vali Asr hospital in Arak. All patients who are under mechanical ventilation for any reason are studied. Due to the nature of the intervention, blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Anesthetized patients hospitalized in the intensive care unit who have been treated with mechanical ventilation (SIMV, PSV, CPAP, BIPAP) for 24 hours before and during the intervention; Age between 65-18 years; Stable hemodynamic status of patients; GCS score of 7 and above.
Non-inclusion criteria:
Death or transfer of the patient from the intensive care unit; Separation from mechanical ventilation; Decreased level of consciousness to less than 7; Induction of anesthesia and use of drugs with neuromuscular blocking effect.
Intervention groups
Intervention group: acupressure is used for them. For this, a special bracelet is used to put pressure on the Neiguan area (P6) in the lower part of the wrist of both hands. This procedure is performed twice a day for three consecutive days.
Control group: Acupressure will not be used for patients in the control group and they will receive only the necessary treatments based on the prescription of the attending physicians.
Evaluation of the effect of acupressure on pain, restlessness and sedation in ventilator patients
Public title
The effect of acupressure in patients on a ventilator
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Anesthetized patients hospitalized in the intensive care unit who have been treated with mechanical ventilation (SIMV, PSV, CPAP, BIPAP) for 24 hours before and during the intervention.
Age of 18-65 years old.
Stable hemodynamic status of patients.
GCS score 7 and above.
Not having a wound or any lesion in the desired area for acupressure.
Not having a history of mental illness and not taking psychiatric drugs according to the patient's companion.
Absence of cardiovascular diseases
Having a prescription for a sedative.
Exclusion criteria:
Death or transfer of the patient from the intensive care unit.
Separation from mechanical ventilation.
Decreased level of consciousness to less than 7.
Induction of anesthesia and use of drugs with neuromuscular blocking effect.
A sudden change in the patient's clinical condition due to cardiopulmonary arrest, severe bleeding and other conditions that require medical interventions or surgery.
The interference of the bracelet used to physically restrain the patient with the area used in acupressure.
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
In this study, patients are placed in the intervention (acupressure) or control (conventional method) groups by block randomization. Blocking is used in order to balance the number of samples allocated to each of the studied groups. The size of all blocks is equal and in this experiment we will have two groups of 4 blocks (including 2 Patient in the intervention group and 2 Patient in the control group).
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 Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.ARAKMU.REC.1401.071
Health conditions studied
1
Description of health condition studied
Patients with reduced level of consciousness in the intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
Pain assessment is done during the study (3 days), and twice everyday at 12-13 and 18-19
Method of measurement
Pain score is measured using Behavioral Pain Scale (BPS).
2
Description
The score of calmness and restlessness
Timepoint
During the study (3 days), and twice everyday at 12-13 and 18-19.
Method of measurement
Using the Richmond scale
3
Description
The amount of used sedatives
Timepoint
End of the study period
Method of measurement
Report the amount of medicine taken for the patient in the patient's file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acupressure is performed using a special bracelet in the lower wrist area (Nigoan area or P6) of both hands for 5 minutes at the same time. This procedure is performed twice a day for three consecutive days.
Category
Treatment - Other
2
Description
Control group: Control group patients receive only routine treatments.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Akbar Mohseni
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
3818887568
Phone
+98 86 3224 8046
Email
akbar111348@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
School of Nursing, Payabbar Azam Complex, Basij Square، Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3383 8309
Email
akbar111348@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing, Payabbar Azam Complex, Basij Square، Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3463
Email
rezaeikorosh0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Akbar Mohseni
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.8 ,Shahamat 1 alley, Amir 2 street, Moshaver town
City
Arak
Province
Markazi
Postal code
3818887568
Phone
+98 86 3368 4982
Email
akbar111348@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Akbar Mohseni
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.8 ,Shahamat 1 alley, Amir 2 street, Moshaver town
City
Arak
Province
Markazi
Postal code
3818887568
Phone
+98 86 3368 4982
Email
akbar111348@yahoo.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
Demographic characteristics and pain score.
When the data will become available and for how long
Start the access period 6 months after the publication of
the results.
To whom data/document is available
All individuals can access the information.
Under which criteria data/document could be used
Nothing.
From where data/document is obtainable
Korosh Rezaei; k.rezaei@arakmu.ac.ir; Arak University of
Medical Sciences; 00989183677622.
What processes are involved for a request to access data/document