Effects of guided imagery on anxiety, muscle pain and vial signs in patients with COVID-19 hospitalized in Taleghani Hospital and temporary housing in Urmia, 2020
Determining the effect of guided mental imagery on anxiety, muscle pain and vital signs in patients with Covid-19
Design
The selected samples will be divided into two groups of intervention and control by simple random sampling. The Envelope cards method will be used to win 110 cards, and the letter G (intervention group with guided mental imagery) and 55 letters C (control group) will be written on 55 cards. The cards will be then mixed together and one of the cards will be randomly selected by the patient and according to the writing on the cards, will be placed in one of two groups. Baseline data including demographic characteristics, vital signs and SPO2% of patients will be obtained in the first session and questionnaires of anxiety and severity and quality of pain in both intervention and control groups will be filled by patients.
Settings and conduct
This study is a clinical trial and research environment is Taleghani hospital in Urmia.
Participants/Inclusion and exclusion criteria
Should be positive for covid-19 with PCR test;
Satisfaction to participate in the study;
Age: between 18 and 60 years;
SPO2% > 93%.
Intervention groups
Intervention group: a guided mental imaging protocol will be performed under the supervision of a psychiatrist.
Control group: routine care in the ward.
Main outcome variables
Level of anxiety; Quality and severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131112015390N5
Registration date:2020-09-26, 1399/07/05
Registration timing:retrospective
Last update:2020-09-26, 1399/07/05
Update count:0
Registration date
2020-09-26, 1399/07/05
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
2020-06-15, 1399/03/26
Actual recruitment end date
2020-07-08, 1399/04/18
Trial completion date
2020-08-10, 1399/05/20
Scientific title
Effects of guided imagery on anxiety, muscle pain and vial signs in patients with COVID-19 hospitalized in Taleghani Hospital and temporary housing in Urmia, 2020
Public title
Effects of guided imagery on anxiety, muscle pain and vial signs in patients with COVID-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The sample should be positive for covid-19 with PCR test.
Be between 18 and 60 years old.
Allow the treating physician to intervene.
The sample must be alert and oriented.
Be able to speak Persian.
Willingness to participate in the study with complete satisfaction.
Exclusion criteria:
The sample have a history of mental illness and a previous history of Covid-19.
SPO2% < 93%
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The selected samples will be divided into two groups of intervention and control by simple random sampling with random allocation. The Envelope cards method will be used to win 110 cards and write the letter G (55 on the intervention group with guided mental imagery) and the other 55 on the letter C (control group). Then the cards are mixed together and at the patient's bedside, one of the cards is randomly selected by the patient and according to the writing on the cards, they will be placed in one of two groups.
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 Urmia University of Medical Sciences
Street address
Resalet Boulevard, Emergency kooy
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.UMSU.REC.1399.102
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Anxiety Scale in Spielberger's Hidden and Obvious Anxiety Scale Questionnaire
Timepoint
Measuring anxiety in the first session (before the intervention) and then After completing the guided mental imagery training sessions on the fifth day
Method of measurement
Spielberger's Hidden and Obvious Anxiety Scale Questionnaire
2
Description
Pain Quality Score on the McGill Pain Questionnaire
Timepoint
Measuring quality of pain in the first session (before the intervention) and then After completing the guided mental imagery training sessions on the fifth day
Method of measurement
McGill Pain Questionnaire
3
Description
Pain intensity score on the Visual Analog Scale
Timepoint
Measuring pain intensity in the first session (before the intervention) and then After completing the guided mental imagery training sessions on the fifth day
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, a guided mental imaging protocol will be performed under the supervision of a psychiatrist. In the intervention group, in parallel with routine care, for each sample, 10 sessions of guided mental imaging methods were performed for five consecutive days, twice a day; It will be performed once in the morning from 9:00 to 9:30 and once in the evening from 18:00 to 18:30 in the patient's room. During each session, the patient listens for about 25 minutes to the headphone-guided mental imagery training mp3 file, and according to the sentences that will be played, closes his eyes, takes a deep breath, and relaxes his muscles to relax completely. It is then directed to the relevant imagery using the power of the mind and imagination.
Category
Behavior
2
Description
Control group: There is no intervention in the control group and they will continue the treatment process based on routine care in the ward.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Educational and Medical Center in Urmia
Full name of responsible person
Naser Parizad
Street address
Kashani St., in front of Takhti Sports Complex, Ayatollah Taleghani Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5915931637
Phone
+98 44 3344 4591
Email
parizad.n@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Street address
Resalet Boulevard, Emergency Cui
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
parizad.n@umsu.ac.ir
Grant name
School of Nursing and Midwifery, Urmia University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Data related to the main outcome of the study will be shared.
When the data will become available and for how long
Data access will begin three months after the results are published.
To whom data/document is available
All researchers and practitioners in the field can access the results.
Under which criteria data/document could be used
Anyone can access the results by pointing to the source used.
From where data/document is obtainable
People can access data from reputable databases that publish results.
What processes are involved for a request to access data/document
Searching for the main outcome of the research or the researchers conducting the research after publishing the results in valid databases