Comparison of Dyang's sensory stimulation and foot reflexology on the level of consciousness and physiological indicators in patients with disorders of consciousness
Determining the effect of Dyang's sensory stimulation and reflex foot massage on the level of consciousness and physiological indicators in patients with consciousness disorders
Design
A double-blind clinical trial with a control group and parallel groups has been randomized
Settings and conduct
In one group, foot reflex massage and in the other group, Dyang's sensory stimulation is performed for one week. The control group receives usual hospital care. Glasgow coma scale, physiological indicators at the beginning of the study and one week after the intervention with time intervals. Two hours after the last intervention, it will be done simultaneously in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Age 18-65
Admission to ICU for more than 3 days
Consciousness level 3-7 based on the Glasgow Coma Scale in neurosurgery and neurological patients such as head trauma, stroke, cerebral hemorrhage, lesions and brain tumors
Connection to the ventilator
Absence of broken limbs
Non-diagnosis of peripheral neuropathy, neuromuscular disorders, skin disorders and sensory disorders in the organs based on the relevant expert's opinion
Not having vision and hearing disorders
No history of drug addiction
Not receiving frequent sedatives and induced coma at the time of the intervention until two hours later
Not receiving narcotic drugs during the intervention until two hours later
Intervention groups
For intervention groups A and B, Dyang's sensory stimulation and foot reflex massage will be performed for one week and twice a day, respectively. The control group will receive usual hospital care.
Main outcome variables
level of consciousness; Physiological indicators (heart rate, breathing rate, systolic and diastolic blood pressure, temperature and percentage of oxygen saturation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059339N1
Registration date:2023-09-11, 1402/06/20
Registration timing:prospective
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Fatemeh Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9392
Email address
fatimaasgari915@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-14, 1402/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dyang's sensory stimulation and foot reflexology on the level of consciousness and physiological indicators in patients with disorders of consciousness
Public title
Comparison of Dyang's sensory stimulation and foot reflexology on the level of consciousness and physiological indicators in patients with disorders of consciousness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65
Admission to ICU for more than 3 days
Consciousness level 3-7 based on the Glasgow coma scale (50) in neurosurgery and neurological patients such as head trauma, stroke, cerebral hemorrhage, lesions and brain tumors
Connection to the ventilator
Absence of broken limbs
Non-diagnosis of peripheral neuropathy, neuromuscular disorders, skin disorders and sensory disorders in the organs based on the relevant expert's opinion
Not having vision and hearing disorders
No history of drug addiction
Not receiving frequent sedatives and induced coma at the time of the intervention until two hours later
Not receiving narcotic drugs during the intervention until two hours later
Exclusion criteria:
The lack of consent of the patient's companions to continue participating in the research
Discharge during intervention implementation process
Transfer to another hospital
death of the patient
Performing surgery during intervention
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
Samples are made in blocks of four and six using Sealed Envelope Ltd software. 2017 available through www.sealedenvelope.com are assigned to three groups (two intervention groups and one 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
Ethics Committee of the Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
Street address
Kashan, Qotbe Ravandi Blvd., Nurse St., Kashan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.104
Health conditions studied
1
Description of health condition studied
patients with consciousness disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of consciousness and physiological indicators
Timepoint
At the beginning of the study and 7 days after the intervention
Method of measurement
Glasgow Coma Scale and Saadat Monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: foot reflexology
Category
Treatment - Other
2
Description
Intervention group: Dyang's sensory stimulation
Category
Treatment - Other
3
Description
Control group: Routine hospital care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Fatemeh Asgari
Street address
Iran, Kashan, Qutb Ravandi Blvd., Nurse St., Kashan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
fatimaasgari915@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Iran, Kashan, Qutb Rawandi Blvd., Nurser St., Kashan University of Medical Sciences, Research and Technology Vice-Chancellor
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Asgari
Position
Training instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
fatimaasgari915@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Asgari
Position
Training instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
009855540021
Email
fatimaasgari915@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
Data of participants are confidential
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