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The effect of multifaceted sensory stimulation on arterial blood oxygen, heart rate, blood pressure and level of consciousness of concussion patients

Protocol summary

Study aim
Determining the effect of multimodal sensory stimulation on arterial blood oxygen, heart rate, blood pressure and level of consciousness in concussion patients
Design
Clinical trial with a control group, with parallel groups, randomized, phase 2, on 64 patients, was used to randomize the block method using two red and white balls.
Settings and conduct
This research is carried out in the special care departments of hospitals in Zahedan city and the intervention consists of a regular and periodic program of sensory stimulation for 6 days, each session lasting a maximum of 30 minutes in two shifts, in the morning and in the evening, which is carried out by the researcher. The main and assistant of the researcher and the patient's family are done, and the arterial blood oxygen level, heart rate, blood pressure and level of consciousness of the patient are measured before and after each intervention in the intervention group and in the control group with similar intervals.
Participants/Inclusion and exclusion criteria
Be admitted to the ward with a diagnosis of concussion; Do not have a history of sensory disorders in the upper limbs; Be in the range of 65 to 11 years; Consciousness level should be in the range of 8 to 10 (according to the Glasgow Coma Scale).
Intervention groups
The intervention in the intervention group includes a regular and periodic program of sensory stimulations including the presentation of different sensory stimulations (auditory, visual, olfactory, tactile and kinetic) according to a program for the patient, and no intervention takes place in the control group.
Main outcome variables
Arterial blood oxygen level; Heartbeat; Blood pressure and level of consciousness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230225057521N1
Registration date: 2024-08-12, 1403/05/22
Registration timing: retrospective

Last update: 2024-08-12, 1403/05/22
Update count: 0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Yaser Moshtaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 4708
Email address
y.moshtaghi18@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-07, 1401/04/16
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multifaceted sensory stimulation on arterial blood oxygen, heart rate, blood pressure and level of consciousness of concussion patients
Public title
The effect of sensory stimulation on the vital signs and level of consciousness of concussion patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient does not have a history of sensory disorders in the upper limbs, and patients without sensory disorders are included in the study according to the doctor's opinion. Don't have a diagnosis of an underlying disease such as diabetes (due to possible neuropathies based on the patient's file). The patient has been admitted to the ward with a diagnosis of concussion. Concussion includes subdural, epidural, intracerebral, ventricular, and subarachnoid hemorrhages. The level of consciousness of the patient should be in the range of 8 to 10 (according to the Glasgow Coma Scale). The patient's age should be between 65 and 11 years. Filling out the written informed consent by the guardians
Exclusion criteria:
The simultaneous participation of the patient in similar care programs such as massage therapy and the use of relaxation techniques and... History of previous brain injury Fractures in four limbs (arms and legs)
Age
From 11 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected by sampling with entry criteria and then divided into intervention and control groups using a random block method using two red and white balls.
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 Zabol University of Medical Sciences
Street address
Ethics Committee of Zabul University of Medical Sciences, Research Affairs Management, Department of Education and Research Assistant, Shahid Rajaei St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.ZBMU.REC.1401.042

Health conditions studied

1

Description of health condition studied
Concussion patients
ICD-10 code
S06.0
ICD-10 code description
Concussion

Primary outcomes

1

Description
Arterial blood oxygen level
Timepoint
Measurement of arterial blood oxygen level in 6 days, 4 times a day, in the morning and evening, before and after the intervention.
Method of measurement
Pulse oximetry device

2

Description
Number of heartbeats
Timepoint
Measurement of heart rate in 6 days 4 times a day in two times in the morning and in the evening before and after the intervention
Method of measurement
Pulse oximetry device

3

Description
Blood pressure (systolic and diastolic)
Timepoint
Measurement of blood pressure (systolic and diastolic) in 6 days, 4 times a day, in the morning and evening, before and after the intervention.
Method of measurement
Sphygmomanometer and stethoscope

4

Description
level of consciousness
Timepoint
Measuring the level of consciousness in 6 days, 4 times a day, twice in the morning and in the evening, before and after the intervention
Method of measurement
Glasgow coma scale chart

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention consists of a regular and periodic program of sensory stimulation for 6 days, each session lasting a maximum of 30 minutes in the morning (8 am) and the evening (4 pm) (2 sessions per day and 12 sessions in the whole program). is. Interventions include providing different sensory stimuli (auditory, visual, olfactory, tactile and kinetic) according to a program for the patient. Interventions include calling the patient's name, informing the patient about the time, place and person (hearing), opening the patient's eyes and moving a flashlight or lamp with colored light in the patient's field of vision (vision), using the smell of hot tea or coffee for Stimulating the patient's smell (smell), putting moist swabs on different parts of the face, trunk and limbs (touch) and changing the position (movement) is done by the main researcher and the assistant researcher and the patient's family. Arterial, heart rate, blood pressure and level of consciousness of the patient are measured before and after each intervention.
Category
Other

2

Description
Control group: No action is taken for this group of patients and they receive routine care like all patients, and arterial blood oxygen level, heart rate, blood pressure and level of consciousness of these patients are measured at the same intervals as the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital
Full name of responsible person
Fariba Kosha
Street address
The beginning of Jam Jam Boulevard, Khatam al-Anbia Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 5015
Email
info@zaums.ac.ir
Web page address
https://khatam.zaums.ac.ir/

2

Recruitment center
Name of recruitment center
Imam Ali Research Hospital
Full name of responsible person
Kaveh Orei Yazdani
Street address
Medical Sciences Campus , Dr. Hasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
info@zaums.ac.ir
Web page address
https://alihos.zaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Khadijeh Rezaei Keikhaei
Street address
ٍEducational complex of Zabol University of Medical Sciences , Shahid Rajaei St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Fax
+98 54 3223 0770
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Yaser Moshtaghi
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 24, Basij 10, Basij Blvd
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861866794
Phone
+98 54 3222 4708
Fax
Email
y.moshtaghi18@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Yaser Moshtaghi
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 24, Basij 10, Basij Blvd
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861866794
Phone
+98 54 3222 4708
Fax
Email
y.moshtaghi18@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Yaser Moshtaghi
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 24, Basij 10, Basij Blvd
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861866794
Phone
+98 54 3222 4708
Fax
Email
y.moshtaghi18@gmail.com

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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