Protocol summary

Study aim
The effect of touching the patient's hand on their level of consciousness and vital signs
Design
This study is a randomized clinical trial with 48 patients in two groups. The touch group by the patient's own hand (first group) and the touch group by the nurse (second group). After the available selection of hospitalized and purpose-based patients, in terms of admission criteria, they are randomly assigned to two groups in equal numbers using quadruple permutation blocks. Blindness for patients due to their lack of consciousness has been investigated and due to the lack of knowledge of the registrar of consciousness and vital signs of the subject in the groups and also a statistical analyst, in fact, this study was designed with two parallel groups, random and double-blind.
Settings and conduct
This randomized clinical trial is performed on patients with impaired level of consciousness (GCS below 8) admitted to intensive care units of Khorasan Razavi (in two groups). In the first group, touch therapy of the face and torso is performed by the patient's own hand, but with the help of a nurse, for six consecutive days and each time for 10 minutes. It takes time. Blinding for patients due to lack of consciousness is practically achieved and does not require special action.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 15-60 years, absence of tactile disorders in different parts of the patient, GCS below 8 Exclusion criteria: dissatisfaction of companions
Intervention groups
The intervention group includes patients who receive sensory stimulation with their own hands. The control group includes patients who receive sensory stimulation through the nurse.
Main outcome variables
Vital signs, level of consciousness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210327050780N1
Registration date: 2021-12-06, 1400/09/15
Registration timing: registered_while_recruiting

Last update: 2021-12-06, 1400/09/15
Update count: 0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Khadijeh Sadeghiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5232 9110
Email address
info@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of touch by nurse with touch by the patient himself on vital signs and level of consciousness of patients admitted to intensive care units
Public title
The effect of touch on vital signs and level of consciousness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Effect by reducing the level of consciousness with the inclusion criteria of age between 15 to 60 Patients with decreased level of consciousness with GCS inclusion criteria below 8 Patients with decreased level of consciousness with the criterion of the absence of various sensory disorders
Exclusion criteria:
Transfer the patient to other medical centers Having sensory problems
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
First, the research units are selected according to the estimated number of available patients admitted to intensive care units according to the inclusion criteria and in a purposful method. Then, using the quadruple block method, they are randomly assigned to two groups of two touch therapy groups (one group by the patient's own hand with help and the other by the nurse, 24 people in each group). In this way, for the group to be touched by the patient's own hand) with the help of the letter A and for the group to be touched by the nurse's hand, the letter B is considered. Possible modes in the four blocks of six modes include AABB, BBAA, ABAB, BABA, ABBA, BAAB, each mode is written on a card and the cards are assigned the number one to six. Then, using a dice, one of the six possible modes is selected and based on that, the selected patients are assigned to two relevant groups. This process continues until the sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Are sensory stimuli performed by patients themselves more effective than sensory stimuli performed by the nurse on the patient? In addition, at present, the policy of meeting in the private sector in the country has many restrictions. In most medical centers, sensory stimulation is performed by nurses and also the role of the patient himself in comparison with nurses in performing sensory stimulation has not been measured in a separate study in Iran. Vital signs and level of consciousness of patients admitted to special wards are not mentioned and this indicates the research gap and knowledge in this regard.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Khordad St. 6, No. 2, Unit 2
City
Torbat Heydariye
Province
Razavi Khorasan
Postal code
9518951607
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.GMU.REC.1399.135

Health conditions studied

1

Description of health condition studied
Loss of consciousness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Level of conciosness
Timepoint
Touch for six consecutive days, each time for 10 minutes in the morning and evening shifts.
Method of measurement
Glasgow Coma Scale

Secondary outcomes

1

Description
Vital Signs
Timepoint
Control vital signs before and after the intervention on 6 consecutive days in the morning and evening
Method of measurement
Respiratory rate by counting the number of ups and downs of the chest, checking systolic and diastolic blood pressure, heart rate with the vital signs monitoring device Saadat brand model S1600 and oral thermometer is used for temperature.

Intervention groups

1

Description
Intervention group 1: the group that is touched by a nurse.
Category
Treatment - Other

2

Description
Intervention group 2:A group that is touched by the patient herself and with the help of a nurse.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Torbat heydariye Razi and 9-day hospital
Full name of responsible person
Khadijeh Sadeghiyan
Street address
Khordad St., Khordad 6, No. 2, Unit 2
City
Torbat Heydariye
Province
Razavi Khorasan
Postal code
9518951607
Phone
+98 51 5232 9110
Email
kh.sadeghiyan59@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Meysam Dastani
Street address
Khorasan Razavi, Gonabad, Imam Khomeini St., Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Khadijeh Sadeghiyan
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khordad St., Khordad 6, No. 2, Unit 2
City
Torbat heydariye
Province
Razavi Khorasan
Postal code
9517951607
Phone
+98 51 5232 9110
Fax
Email
kh.sadeghiyan59@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Khadijeh Sadeghiyan
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khordad St., Khordad 6, No. 2, Unit 2
City
Torbat heydariye
Province
Razavi Khorasan
Postal code
9517951607
Phone
+98 51 5232 9110
Fax
Email
kh.sadeghiyan59@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Khadijeh Sadeghiyan
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khordad St., Khordad 6, No. 2, Unit 2
City
Torbat heydariye
Province
Razavi Khorasan
Postal code
9517951607
Phone
+98 51 5232 9110
Fax
Email
kh.sadeghiyan59@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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