Protocol summary
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Study aim
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Determining the effect of percutaneous electrical nerve stimulation on respiratory outcomes in patients with Covid-19
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Design
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A clinical trial with a control group, with parallel groups, three-way, randomized, on 84 patients. For randomization, the 4-block method was used using software.
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Settings and conduct
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Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random assignment of patients with two intervention and control groups, the intervention is performed in such a way that two electrodes are placed on both sides of the spinal cord of the 7-neck vertebra, and in the control group, the electrodes are placed on non-acupuncture points. Breathing (anterior to the chest) is connected and flow is established.
Participants, data collectors and statistical analysts were also blinded to the groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Covid-19 with moderate pulmonary involvement
Non-entry or exclusion criteria: Addiction, heart disease, liver, respiratory, kidney and advanced cancer, history of allergies and skin lesions and obesity and prohibition to be in a semi-sitting position
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Intervention groups
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In the intervention group, the patient is placed in a sitting or semi-sitting position, two plastic electrodes of 5 * 5 cm and adhesive are placed on both sides of the spinal appendage of the 7-neck vertebra; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. In the control group, the electrodes of the device are connected to the non-respiratory acupuncture points (anterior of the chest) and the current is established in the same way.
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Main outcome variables
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Respiratory consequences
General information
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Reason for update
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Change in sample size and update the realized sampling time
The order of study outcomes also changed according to the importance of the outcomes observed during the implementation of the intervention and updated treatment protocols. In addition, the quality of shortness of breath was eliminated due to overlap with other outcomes and the large number of questions asked of the patient, leading to fatigue.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210406050871N1
Registration date:
2021-04-25, 1400/02/05
Registration timing:
prospective
Last update:
2022-07-06, 1401/04/15
Update count:
1
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Registration date
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2021-04-25, 1400/02/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-30, 1400/02/10
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Expected recruitment end date
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2021-08-01, 1400/05/10
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Actual recruitment start date
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2021-06-01, 1400/03/11
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Actual recruitment end date
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2021-09-30, 1400/07/08
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Trial completion date
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empty
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Scientific title
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The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial
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Public title
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The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmation of Covid-19 diagnosis based on PCR test results or CT Scan findings (Ground Glass view) by physician
Age over 18 and under 70 years
Use the same treatment protocol for patients
Existence of moderate pulmonary involvement (SpO2 between 90 to 93% and pulmonary involvement less than 50%) and the patient being in the second phase of Covid-19 disease according to the guideline of the Ministry of Health
Exclusion criteria:
Drug addiction
Cigarette addiction
Advanced metastatic cancer
Congestive heart failure (grades 3 and 4)
Kidney failure requires dialysis
History of mechanical ventilation before intervention
Existence of cardiac pacemaker
Cardiac conduction disorders
History of allergies and skin sensitivities in the area of the electrodes
The presence of a skin lesion in the area where the electrodes are placed
Hospitalized patients with other clinical manifestations of Covid-19 and no pulmonary involvement
Continuous use of bronchodilators
Having liver failure
Moderate to severe scoliosis
Obesity (BMI above 35)
Psychological illnesses lead to lack of patient cooperation
Cerebrovascular disorders
Having COPD
Having uncontrolled diabetes
Inability and prohibition to be in a semi-sitting position for any reason
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
84
Actual sample size reached:
82
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal.
In this research, the random allocation sequence is obtained by the methodology consultant with the software.
After creating a random sequence, 84 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box.
Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The present study is three-blind and in addition to the participants, the data collector (outcome assessor) and the statistical analyst are not aware of the allocation of groups.
The data collector who is involved in collecting and recording information such as respiration rate, pulse, oxygen saturation, etc., or in completing questionnaires will be unaware of the group of individuals.
The analyst will also be unaware of the group of people.
It should be noted that the physiotherapist who is responsible for the intervention and is known as the caregiver, by contacting the research colleague who has the sequence, becomes aware of the group to which each person is assigned and performs the intervention.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-11, 1400/01/22
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Ethics committee reference number
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IR.SHMU.REC.1400.008
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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Coronavirus disease (COVID-19)
Primary outcomes
1
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Description
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Percentage of arterial blood oxygen saturation
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Timepoint
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Daily for up to 4 days before and after the intervention
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Method of measurement
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Finger pulse oximeter device and monitor
2
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Description
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need for mechanical ventilation
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Timepoint
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4, 8 and 12 days after the intervention
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Method of measurement
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Checklist
3
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Description
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Death and survival
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Timepoint
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until the end of hospitalization
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Method of measurement
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Checklist
4
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Description
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vital signs (RR,HR)
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Timepoint
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Daily for up to 4 days before and after the intervention
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Method of measurement
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Count the respiratory rate and heart rate in a minute and record them in a checklist
5
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Description
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Severity of breathing (Dyspnea)
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Timepoint
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Daily for up to 4 days before and after the intervention
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Method of measurement
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Visual Analogue scale for dyspnea (VASD)
Intervention groups
1
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Description
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Intervention group: is performed by a researcher who does not know the assignment of groups under the supervision of an Acu-TENS trained physiotherapist for the intervention group in such a way that the patient is in a sitting or semi-sitting position and by re-controlling the skin of the area for lesions, Two plastic electrodes 5 × 5 cm and sticky are placed on both sides of the spine appendage of 7 cervical vertebrae; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
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Category
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Treatment - Devices
2
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Description
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Control group: by a researcher who does not know the assignment of groups under the supervision of a trained physiotherapist, ineffective Acu-TENS was performed for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling, the skin of in view of the lesion, two plastic electrodes of 5* 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as information about the main outcome, can be shared.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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If necessary, contact Dr. Mahboobeh Khajeh and if there is a reasonable justification for use in scientific purposes
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From where data/document is obtainable
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Dr. Mahboobeh Khajeh
Shahroud, 7thTir Square, Shahroud University of Medical Sciences;
School of Nursing and Midwifery
02332395054
m_khajeh@ymail.com
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What processes are involved for a request to access data/document
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By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks
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Comments
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