Protocol summary

Study aim
The aim of this study is to assess the effect of acupressure on anxiety, agitation, respiratory and physiologic parameters in patients during weaning of mechanically ventilation in the intensive care unit.
Design
Samples will be chosen from the patients admitted to Bu-Ali Sina hospital affiliated with Qazvin University of Medical Sciences. In this randomized controlled clinical trial, 80 patients will be randomly assigned to the experiment and control groups. The patients will be blinded to the study.
Settings and conduct
This study will be done in intensive care unit of Bu-Ali Sina hospital of Medical Science University in Qazvin city.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Four score ≥ 9;Richmond from +2 to -2; PaO2 ≥ 60 mmHg ، ABG: FiO2 ≤ 40%، PaO2 ≥ 60 mmHg, 25≥ RR); age over 18 ; Patient intubated for past 48 hours; Are on ventilation with SIMV ،PSV mode; Hemoglobin ≥ 8 mg/dl ; Without malformation or grazes in pressure points ; Haveing no psychiatric illness ; Haveing no neuromuscular illness ; Haveing no active heart disease ; Haveing no neurologic disorder that affect on respiratory ; taking no psychiatric agent ; taking no neuromuscular blocker agent; taking no sedative during past 4 hours; PTT≤60) . Exclusion criteria: Patient with no cooperation up to the end of study; Weaning of mechanical ventilation; Death of patient during the study; Daley of weaning process.
Intervention groups
Deep pressure in the experiment group and touch in the control group will perform at 5- acupoints on both sides of the body. The intervention will be carried out 20 minutes before weaning of mechanical ventilation by an educated person. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique is performed on one side of the body and then the other side of the body based on the patient's condition. Anxiety, agitation and oxygen saturation and the effect of anxiety on physiologic parameters including blood pressure, heart rate, oxygen saturation and respiratory indexes before the intervention, immediately after the intervention, under T-piece, 20 min after T-piece will be measured.
Main outcome variables
Anxiety, agitation, blood gases are measured and also the effects of anxiety on physiologic parameters including blood pressure, heart rate, Oxygen saturation of arterial blood and respiratory indexes before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110912007529N16
Registration date: 2017-12-27, 1396/10/06
Registration timing: registered_while_recruiting

Last update: 2017-12-27, 1396/10/06
Update count: 0
Registration date
2017-12-27, 1396/10/06
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acupressure therapy on anxiety, agitation and physiologic parameters in patients weaning from mechanical ventilation
Public title
Effects of acupressure therapy on patients weaning from mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Four score ≥ 9 Richmond score from +2 to -2 PaO2 ≥ 60 mmHg ، ABG: FiO2 ≤ 40%، PaO2 ≥ 60 mmHg, 25≥ RR) age over 18 being intubated during past 48 hours being on ventilation with SIMV and PSV mode Hemoglobin ≥ 8 mg/dl Absence of malformation or grazes in pressure points Absence of psychiatric illness Absence of neuromuscular illness Absence of active heart disease Absence of neurologic disorder that affects respiratory not taking any psychiatric agent not taking any neuromuscular blocker agent not taking sedative during past 4 hours absence of coagulation disturbance (PTT≤60)
Exclusion criteria:
Exclusion criteria :Patient with no cooperation to end of study ; Weaning of mechanical ventilation ; Death of patient during the study ; Daley of weaning process.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned into two groups using permuted block randomization , Random numbers table will be used, Random allocation sequence will be determined using a computerized program.Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
patients will be unaware of the groups’assignments.staff nurses in the ICU and the statistical analyzer will be blind to patients’allocation of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite the Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
Shahed.REC.1396.51

Health conditions studied

1

Description of health condition studied
Patients with impaired respiratory function in ICU
ICD-10 code
J95 , J96
ICD-10 code description
Other diseases of the respiratory system

Primary outcomes

1

Description
Anxiety
Timepoint
before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece.
Method of measurement
by Faces anxiety scale

2

Description
Agitation
Timepoint
before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece.
Method of measurement
Richmond Scale

Secondary outcomes

1

Description
Heart rate
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

2

Description
Respiratory rate
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Ventilator system

3

Description
Oxygen saturation of arterial blood ( SPo2 )
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Pulsoximeter

4

Description
Heart rate
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

5

Description
Systolic Blood pressure
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

6

Description
Diastolic blood pressure
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

7

Description
Mean blood pressure
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

8

Description
Tidal Volume
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

9

Description
minute Ventilation
Timepoint
Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece
Method of measurement
Monitoring system

Intervention groups

1

Description
The experiment group: Acupressure will be performed in this group. The intervention is performed 20 minutes before weaning of mechanically ventilation by a trained person. This technique will be implemented at 5- acupoints on both sides of the body. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique will be performed on one side of the body first and then the other side of the body based on the patient's condition. Anxiety, agitation and physiologic parameters are measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece. T–piece device is placed on the tracheal tube and a high level of oxygen is given to the patients. In addition to administering oxygen, the device can produce about 5 cm PEEP water and an increase in PaCo2 by providing an exhale-resistant resistor.
Category
Treatment - Other

2

Description
In control group, touch will be performed at 5 points except the main points in intervention group, 20 minutes before weaning of mechanical ventilation. Anxiety, agitation, and physiologic parameters will be measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu-Ali Sina hospital
Full name of responsible person
Fatemeh Zavareh Esfahani
Street address
No.11, Bu-Ali Sina hospital, Sina Ave, Qazvin.
City
Qazvin
Province
Tehran
Postal code
33332930
Phone
Email
hosboali@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Email
Kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahed University
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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