ٍEvaluating the effects of psychological interventions on pain, anxiety and physiological parameters in the patients with cerebral stroke hospitalized in the intensive care unit: a parallel randomized clinical trial
Evaluating the effects of psychological interventions on pain, anxiety, and physiological parameters in patients with stroke hospitalized in the intensive care unit: a parallel randomized clinical trial
Design
Randomized, sham controlled clinical trial with a parallel group, 24 people are randomly divided into control and experimental groups using the block randomization method.
Settings and conduct
Psychological interventions include acupressure, relaxation with guided imagery and music therapy once a day for five consecutive days in intensive care unit Hazrat Abolfazl hospital
Participants/Inclusion and exclusion criteria
Patients (man or woman) experiencing the first unilateral cerebral stroke, who do not have other neurological disorders, diagnosed and referred by a neurologist
Intervention groups
All patients receive conventional evidence-based treatment for the care of patients with cerebral stroke. The control group receives only the conventional treatment, and the intervention group receives psychological interventions including Benson's skewing, music therapy, compression massage and guided imagery in addition to the conventional treatment.
Main outcome variables
Pain; anxiety; physiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040432N4
Registration date:2020-12-30, 1399/10/10
Registration timing:registered_while_recruiting
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Reza Mohammadpourhodki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5542 4875
Email address
rezamdpour@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEvaluating the effects of psychological interventions on pain, anxiety and physiological parameters in the patients with cerebral stroke hospitalized in the intensive care unit: a parallel randomized clinical trial
Public title
Effects of psychological interventions on pain, anxiety, and physiological parameters in patients with cerebral stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consciousness level based on the Glasgow Coma Index (GCS) greater than 9
ُThe diagnosis of hemorrhagic or ischemic cerebral stroke
The age of 18 to 75 years
Exclusion criteria:
The death of patient during the study
The exacerbation of stroke during the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
During the study and due to the small sample size, based on consultation with a statistician, it was decided to use the block randomization method. Blocking is usually done to create a balance in the number of the samples assigned to each of study groups. As we had two study groups, the statistician using a statistical software designed 6 blocks of 4 members.
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 Mashhad University of Medical Sciences
Street address
Knowledge and Health Town, between Shaheed Javan and Al-Shahidi squares, Shaheed Fakouri Blvd (In front of Fakouri 94), Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
IR.MUMS.REC.1399.516
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.MUMS.REC.1399.516
Health conditions studied
1
Description of health condition studied
Cerebral stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Pain
Timepoint
Before the start of intervention at the first session and after the end of intervention at the last session
Method of measurement
VAS questionnaire
2
Description
Anxiety
Timepoint
Before the start of intervention at the first session and after the end of intervention at the last session
Method of measurement
VAS questionnaire
3
Description
Changes of the physiological parameters of patients with cerebral stroke
Timepoint
Before the start of intervention at the first session and after the end of intervention at the last session
Method of measurement
The monitor used in the intensive care unit and a mercury thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, patients will receive only the usual care of the department (these include: physician's examination, daily drug therapy, serum therapy).
Category
N/A
2
Description
Intervention group: Patients with cerebral stroke during five intervention sessions on five consecutive days receive compression massage and relaxation along with guided imagery and music therapy for approximately 55 minutes per session.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Abolfazl hospital
Full name of responsible person
Reza Mohammadpourhodki
Street address
Janbaz Street, Kashmar, Iran
City
Kashmar
Province
Razavi Khorasan
Postal code
9671983514
Phone
+98 51 5526 5404
Email
rezamdpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
international@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
University lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 5525 4590
Email
rezamdpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
University lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 5525 4590
Email
rezamdpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Keramati
Position
Pathology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 5525 4590
Email
smk9289@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