Evaluation the effect of progressive muscle relaxation training with demonstration method on the level of stress, anxiety and depression of nurses encountering of COVID-19
Determining the effect of progressive muscle relaxation training with demonstration methods on the level of stress, anxiety, and depression of nurses encountering COVID-19
Design
A clinical trial with the control group, with a parallel-group design, non-blind, randomized, 2-phase groups on 46 nurses. Randomization software and block randomization method will be used for randomization.
Settings and conduct
The study site will be COVID-19 wards of Khanevadeh and Besat hospitals in Tehran, where nurses working in COVID-19 wards will be selected by available methods. No blinding is performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nurses with at least a bachelor's degree in nursing, with at least six months of clinical experience. Non-inclusion criteria: taking anti-anxiety and psychoactive drugs; the history of receiving previous training on the Jacobson technique; the experience of crisis during the last 6 months.
Intervention groups
Intervention group: The intervention group will perform Jacobson's progressive muscle relaxation technique at home, 20 minutes once a day for 2 weeks. Control group: No special intervention will be performed in this group.
Main outcome variables
Stress, anxiety, depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210808052111N1
Registration date:2021-09-04, 1400/06/13
Registration timing:prospective
Last update:2021-09-04, 1400/06/13
Update count:0
Registration date
2021-09-04, 1400/06/13
Registrant information
Name
Samaneh گنجعلی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 0929
Email address
samaneganjeali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of progressive muscle relaxation training with demonstration method on the level of stress, anxiety and depression of nurses encountering of COVID-19
Public title
The effect of progressive muscle relaxation training with demonstration methods on the level of stress, anxiety and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a bachelor's degree in nursing
Has at least six months of clinical experience
Exclusion criteria:
Taking anti-anxiety and psychoactive drugs
History of previous training in Jacobson relaxation technique
Crisis experience by participants in the study during the last 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be available; the samples will then be placed in quadruple blocks by block random sampling. The size of all blocks is equal and in this two-group Clinical Trial, we will have blocks of size 4 (including 2 people participating in the intervention group and 2 people participating in the control group). Random allocation software is also used for randomization tools. For hiding, allocation concealment is used, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the person is assigned. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to keep up a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the envelopes will be closed and placed inside a box. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
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 Aja University of Medical Sciences
Street address
Etemadzadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.AJAUMS.REC.1400.041
Health conditions studied
1
Description of health condition studied
stress
ICD-10 code
Z56.3
ICD-10 code description
Stressful work schedule
2
Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
3
Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Stress
Timepoint
Before and one month after the intervention
Method of measurement
DASS-21 questionnaire
2
Description
Anxiety
Timepoint
Before and one month after the intervention
Method of measurement
DASS-21 questionnaire
3
Description
Depression
Timepoint
Before and one month after the intervention
Method of measurement
DASS-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will perform Jacobson's progressive muscle relaxation technique for 2 weeks, once a day for 20 minutes each time at home. The practical demonstration of a progressive muscle relaxation technique is performed and taught by the researcher himself in the hospital amphitheater during two 60-minute sessions (Every other day). The first session will be a practical demonstration of how to relax and the second session will be a repetition of the first session in order to consolidate the training. At the end of the training sessions, the video of that session will be given to the test group to act only according to the training they have received in practice. The progressive muscle relaxation technique taught will be such that the nurse is sitting or lying in a comfortable chair. Preferably, the subjects' clothes are loose and the watch takes off its bracelet. Then, with the guidance of the instructor and by listening to the audiotape, he contracts and relaxes different muscle groups along with effective and deep breathing. In this technique, large muscle groups are first contracted and relaxed; Because the contraction and relaxation of these muscles and understanding the difference between these two feelings at the beginning of the work is more tangible for people. When the participant contracts and relaxes each of his muscles, he is able to easily and spontaneously relax his whole body in the way he has learned, and from anxiety, stress, and any unpleasant mental, psychological and physical feelings. Clear
Category
Treatment - Other
2
Description
Control group: No special intervention will be performed in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khanevadeh Artesh Hospital
Full name of responsible person
Samaneh Ganjeali
Street address
Kaj Street, in front of Baharshiraz Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1716577050
Phone
+98 21 7763 3506
Email
samaneganjeali@yahoo.com
2
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Samaneh Ganjeali
Street address
Hejrat Street, Takhti Three Ways, Basij Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
samaneganjeali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zeshk
Street address
Etemadzadeh Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
samaneganjeali@yahoo.com
Web page address
http://ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Samaneh Ganjeali
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kaj Street, in front of Baharshiraz Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
16151116139
Phone
+98 21 7750 0929
Email
samaneganjeali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Farsi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kaj Street, in front of Baharshiraz Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1615116139
Phone
+98 21 7750 0929
Email
Zahrafarsi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Samaneh Ganjeali
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kaj Street, in front of Baharshiraz Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
16151116139
Phone
+98 21 7750 0929
Email
samaneganjeali@yahoo.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