Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
This study is being performed on health care workers at Al-Zahra Hospital in Isfahan. 70 healthcare workers will randomly divide into two groups and the intervention group underwent a one-shot cognitive behavioral therapy intervention. Blinding is done by assigning a unique code to patients and the outcome assessor and the data analyzer are unaware of the groups.
This study is being performed on health care workers at Al-Zahra and Khorshid Hospitals in Isfahan. 70 healthcare workers will randomly divide into two groups and the intervention group underwent a one-shot cognitive behavioral therapy intervention. Blinding is done by assigning a unique code to patients and the outcome assessor and the data analyzer are unaware of the groups.
This study is being performed on health care workers at Al-Zahra Hospitaland Khorshid Hospitals in Isfahan. 70 healthcare workers will randomly divide into two groups and the intervention group underwent a one-shot cognitive behavioral therapy intervention. Blinding is done by assigning a unique code to patients and the outcome assessor and the data analyzer are unaware of the groups.
مطالعه در بیمارستان الزهرا اصفهان روی کارکنان سلامت انجام می شود. 70 نفر از کارکنان سلامت به صورت تصادفی در دو گروه قرار گرفته و گروه مداخله تحت مداخله رفتاردرمانی شناختی تک جلسه ای قرار می گیرد. کورسازی از طریق اختصاص کد منحصر به فرد به بیماران انجام شده و مسئول ارزیابی پیامد و مسئول انالیز داده ها نسبت به قرارگیری افراد در گروه ها ناآگاه هستند.
مطالعه در بیمارستان الزهرا و خورشید اصفهان روی کارکنان سلامت انجام می شود. 70 نفر از کارکنان سلامت به صورت تصادفی در دو گروه قرار گرفته و گروه مداخله تحت مداخله رفتاردرمانی شناختی تک جلسه ای قرار می گیرد. کورسازی از طریق اختصاص کد منحصر به فرد به بیماران انجام شده و مسئول ارزیابی پیامد و مسئول انالیز داده ها نسبت به قرارگیری افراد در گروه ها ناآگاه هستند.
مطالعه در بیمارستان الزهرا و خورشید اصفهان روی کارکنان سلامت انجام می شود. 70 نفر از کارکنان سلامت به صورت تصادفی در دو گروه قرار گرفته و گروه مداخله تحت مداخله رفتاردرمانی شناختی تک جلسه ای قرار می گیرد. کورسازی از طریق اختصاص کد منحصر به فرد به بیماران انجام شده و مسئول ارزیابی پیامد و مسئول انالیز داده ها نسبت به قرارگیری افراد در گروه ها ناآگاه هستند.
Inclusion Criteria: Healthcare workers who work in ALzahra hospital, insomnia score of 8 and higher based on Insomnia Severity Index; Exclusion criteria: History of cardiovascular disease, history of seizure, manic depressive disorder, narcolepsy, and parasomnia, using beta-adrenergic blockade or antiarrhythmic medications
Inclusion Criteria: Healthcare workers who work in ALzahra hospital, insomnia score of 8 and higher based on Insomnia Severity Index, age 18 years old and above; Exclusion criteria: History of cardiovascular disease, history of seizure, manic depressive disorder, narcolepsy, and parasomnia, using beta-adrenergic blockade or antiarrhythmic medications
Inclusion Criteria: Healthcare workers who work in ALzahra hospital, insomnia score of 8 and higher based on Insomnia Severity Index, age 18 years old and above; Exclusion criteria: History of cardiovascular disease, history of seizure, manic depressive disorder, narcolepsy, and parasomnia, using beta-adrenergic blockade or antiarrhythmic medications
معیارهای ورود: کارکنان سلامت شاغل در بیمارستان الزهرا، نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی، معیارهای عدم ورود: سابقه بیماری های قلبی عروقی، سابقه صرع، اختلالات دوقطبی، نارکولپسی یا پاراسومنیا، مصرف داروهای بلوکر بتا ادرنرژیک یا انتی اریتمی
معیارهای ورود: کارکنان سلامت شاغل در بیمارستان الزهرا، نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی، سن بالای 18 سال؛ معیارهای عدم ورود: سابقه بیماری های قلبی عروقی، سابقه صرع، اختلالات دوقطبی، نارکولپسی یا پاراسومنیا، مصرف داروهای بلوکر بتا ادرنرژیک یا انتی اریتمی
معیارهای ورود: کارکنان سلامت شاغل در بیمارستان الزهرا، نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی، سن بالای 18 سال؛ معیارهای عدم ورود: سابقه بیماری های قلبی عروقی، سابقه صرع، اختلالات دوقطبی، نارکولپسی یا پاراسومنیا، مصرف داروهای بلوکر بتا ادرنرژیک یا انتی اریتمی
Intervention group: The sleep diary sheets are given to participants to be completed by them within the next 2 weeks. Then participants are divided into 5 groups of 7 people and each group will come for a group meeting (for one-shot cognitive behavioral therapy) at a specific time. An ECG will be recorded for 8 minutes before the start of the session to assess changes in basal heart rate. After a month, the consequences are reviewed. Control group: includes hospital health staff for whom no intervention is performed and only at similar times in the intervention group, heart rate changes and insomnia severity are evaluated for them.
Intervention group: The sleep diary sheets are given to participants to be completed by them within the next 2 weeks. Then participants are divided into groups of 2-3 people and each group will come for a group meeting (for one-shot cognitive behavioral therapy) at a specific time. An ECG will be recorded for 5 minutes before the start of the session to assess changes in basal heart rate. After a month, the consequences are reviewed. Control group: includes hospital health staff for whom no intervention is performed and only at similar times in the intervention group, heart rate changes and insomnia severity are evaluated for them.
Intervention group: The sleep diary sheets are given to participants to be completed by them within the next 2 weeks. Then participants are divided into 5 groups of 72-3 people and each group will come for a group meeting (for one-shot cognitive behavioral therapy) at a specific time. An ECG will be recorded for 85 minutes before the start of the session to assess changes in basal heart rate. After a month, the consequences are reviewed. Control group: includes hospital health staff for whom no intervention is performed and only at similar times in the intervention group, heart rate changes and insomnia severity are evaluated for them.
گروه مداخله: کار برگ های ثبت خواب به شرکت کنندگان داده می شود تا در طی 2 هفته پیش رو توسط انها تکمیل گردد. شرکت کنندگان به 5 گروه 7 نفره تقسیم می شوند و هر گروه در زمان مشخص جهت جلسه حضوری گروهی به صورت رفتاردرمانی شناختی تک جلسه ای مراجعه خواهد کرد. قبل از شروع جلسه به مدت 8 دقیقه از هر نفر نوار قلب جهت ارزیابی تغییرات ضربان قلب پایه ثبت خواهد شد. پس از یک ماه پیامدها بررسی می شوند. گروه کنترل: شامل کارکنان سلامت بیمارستان است که مداخله ای برای انها صورت نمی گیرد و تنها در زمان های مشابه گروه مداخله تغییرات ضربان قلب و شدت بیخوابی برایشان ارزیابی می شود.
گروه مداخله: کار برگ های ثبت خواب به شرکت کنندگان داده می شود تا در طی 2 هفته پیش رو توسط انها تکمیل گردد. شرکت کنندگان به 5گروه های 2 تا 3 نفره تقسیم می شوند و هر گروه در زمان مشخص جهت جلسه حضوری گروهی به صورت رفتاردرمانی شناختی تک جلسه ای مراجعه خواهد کرد. قبل از شروع جلسه به مدت 5 دقیقه از هر نفر نوار قلب جهت ارزیابی تغییرات ضربان قلب پایه ثبت خواهد شد. پس از یک ماه پیامدها بررسی می شوند. گروه کنترل: شامل کارکنان سلامت بیمارستان است که مداخله ای برای انها صورت نمی گیرد و تنها در زمان های مشابه گروه مداخله تغییرات ضربان قلب و شدت بیخوابی برایشان ارزیابی می شود.
گروه مداخله: کار برگ های ثبت خواب به شرکت کنندگان داده می شود تا در طی 2 هفته پیش رو توسط انها تکمیل گردد. شرکت کنندگان به 5 گروه 75گروه های 2 تا 3 نفره تقسیم می شوند و هر گروه در زمان مشخص جهت جلسه حضوری گروهی به صورت رفتاردرمانی شناختی تک جلسه ای مراجعه خواهد کرد. قبل از شروع جلسه به مدت 85 دقیقه از هر نفر نوار قلب جهت ارزیابی تغییرات ضربان قلب پایه ثبت خواهد شد. پس از یک ماه پیامدها بررسی می شوند. گروه کنترل: شامل کارکنان سلامت بیمارستان است که مداخله ای برای انها صورت نمی گیرد و تنها در زمان های مشابه گروه مداخله تغییرات ضربان قلب و شدت بیخوابی برایشان ارزیابی می شود.
General information
empty
18
18
empty
Year
year
Yes
No
1
empty
57
57
empty
2021-04-21, 1400/02/01
2021-04-21 00:00:00
empty
2021-07-22, 1400/04/31
2021-07-22 00:00:00
empty
2021-09-22, 1400/06/31
2021-09-22 00:00:00
empty
This study is carried on healthcare workers. During the recruitment, they were involved with the 4th wave of the Covid-19 pandemic. Hence, we had to change the protocol.
This study is carried on healthcare workers. During the recruitment, they were involved with the 4th wave of the Covid-19 pandemic. Hence, we had to change the protocol.
empty
با توجه به اینکه این مطالعه روی کارکنان سلامت انجام می شود و در زمان نمونه گیری کارکنان سلامت درگیر موج چهارم کووید بودند مجبور به تغییر پروتوکل شدیم
با توجه به اینکه این مطالعه روی کارکنان سلامت انجام می شود و در زمان نمونه گیری کارکنان سلامت درگیر موج چهارم کووید بودند مجبور به تغییر پروتوکل شدیم
Healthcare workers who work in ALzahra hospital
Insomnia score of 8 and higher based on insomnia severity index
Healthcare workers who work in ALzahra and Khorshid hospital
Insomnia score of 8 and higher based on insomnia severity index
age over 18 years old
Healthcare workers who work in ALzahra and Khorshid hospital Insomnia score of 8 and higher based on insomnia severity index age over 18 years old
کارکنان سلامت شاغل در بیمارستان الزهرا
نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی
کارکنان سلامت شاغل در بیمارستان الزهرا و خورشید
نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی
سن بالای 18 سال
کارکنان سلامت شاغل در بیمارستان الزهرا و خورشید نمره بیخوابی 8 و بالاتر براساس پرسشنامه شدت بیخوابی سن بالای 18 سال
Intervention groups
#1
Intervention group: This group first completes sleep dairy for two weeks and then receives a group session (in groups of 7) of a one-session cognitive behavioral intervention based on their sleep status and sleep habits.
Intervention group: This group first completes sleep dairy for two weeks and then receives a group session (in groups of 2-3) of a one-session cognitive behavioral intervention based on their sleep status and sleep habits.
Intervention group: This group first completes sleep dairy for two weeks and then receives a group session (in groups of 72-3) of a one-session cognitive behavioral intervention based on their sleep status and sleep habits.
گروه مداخله: این گروه ابتدا به مدت دو هفته sleep dairy را تکمیل کرده و سپس یک جلسه به صورت گروهی (در گروه های 7 نفره) مداخله رفتاری شناختی تک جلسه ای را براساس وضعیت خواب و عادات خواب خود دریافت می کنند
گروه مداخله: این گروه ابتدا به مدت دو هفته sleep dairy را تکمیل کرده و سپس یک جلسه به صورت گروهی (در گروه های 2-3 نفره) مداخله رفتاری شناختی تک جلسه ای را براساس وضعیت خواب و عادات خواب خود دریافت می کنند
گروه مداخله: این گروه ابتدا به مدت دو هفته sleep dairy را تکمیل کرده و سپس یک جلسه به صورت گروهی (در گروه های 72-3 نفره) مداخله رفتاری شناختی تک جلسه ای را براساس وضعیت خواب و عادات خواب خود دریافت می کنند
Recruitment centers
#1
Name of recruitment center - English: Khorshid Hospital
Name of recruitment center - Persian: بیمارستان خورشید
Full name of responsible person - English: Babak Amra
Full name of responsible person - Persian: بابک امرا
Street address - English: Ostandari St.
Street address - Persian: استانداری
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8145831451
Phone: +98 31 3263 8279
Fax:
Email: amra@med.mui.ac.ir
Web page address:
Name of recruitment center - English: Khorshid Hospital Name of recruitment center - Persian: بیمارستان خورشید Full name of responsible person - English: Babak Amra Full name of responsible person - Persian: بابک امرا Street address - English: Ostandari St. Street address - Persian: استانداری City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8145831451 Phone: +98 31 3263 8279 Fax: Email: amra@med.mui.ac.ir Web page address:
Protocol summary
Study aim
Study the effect of one shot cognitive behavioral therapy on insomnia and heart rate variability of health care workers at the time of Covid-19 pandemic
Design
Clinical trial, with parallel groups, for 70 patients, randomized using a random string, double-blind, the outcome evaluator and data analyzer will be blinded,
Settings and conduct
This study is being performed on health care workers at Al-Zahra and Khorshid Hospitals in Isfahan. 70 healthcare workers will randomly divide into two groups and the intervention group underwent a one-shot cognitive behavioral therapy intervention. Blinding is done by assigning a unique code to patients and the outcome assessor and the data analyzer are unaware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthcare workers who work in ALzahra hospital, insomnia score of 8 and higher based on Insomnia Severity Index, age 18 years old and above; Exclusion criteria: History of cardiovascular disease, history of seizure, manic depressive disorder, narcolepsy, and parasomnia, using beta-adrenergic blockade or antiarrhythmic medications
Intervention groups
Intervention group: The sleep diary sheets are given to participants to be completed by them within the next 2 weeks. Then participants are divided into groups of 2-3 people and each group will come for a group meeting (for one-shot cognitive behavioral therapy) at a specific time. An ECG will be recorded for 5 minutes before the start of the session to assess changes in basal heart rate. After a month, the consequences are reviewed. Control group: includes hospital health staff for whom no intervention is performed and only at similar times in the intervention group, heart rate changes and insomnia severity are evaluated for them.
Main outcome variables
insomnia, heart rate variability
General information
Reason for update
This study is carried on healthcare workers. During the recruitment, they were involved with the 4th wave of the Covid-19 pandemic. Hence, we had to change the protocol.
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037964N4
Registration date:2021-03-20, 1399/12/30
Registration timing:prospective
Last update:2021-12-18, 1400/09/27
Update count:1
Registration date
2021-03-20, 1399/12/30
Registrant information
Name
Babak Amra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
amra@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
2021-04-21, 1400/02/01
Actual recruitment end date
2021-07-22, 1400/04/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
study the effect of one shot cognitive behavioral therapy on insomnia and heart rate variability of healthcare workers at the time of covid-19
Public title
study the effect of cognitive therapy on insomnia and heart rate variability of health care workers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthcare workers who work in ALzahra and Khorshid hospital
Insomnia score of 8 and higher based on insomnia severity index
age over 18 years old
Exclusion criteria:
History of cardiovascular disease
History of seizure, manic depressive disorder, narcolepsy and parasomnia
Using beta adrenergic blockade or anti arrhythmic medications
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
57
Randomization (investigator's opinion)
Randomized
Randomization description
A random sequence for 70 numbers is made using randomization.com and is available to the research assistant. Each person is given a code (from one to 70). The research assistant places the person in the relevant groups by matching the person's code with a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person is given a unique code and these codes are given to the research assistant. The person in charge of data analysis and the person in charge of follow-up are unaware of their allocation to study groups and study codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.MUI.MED.REC.1399.1153
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
F51.01
ICD-10 code description
Primary insomnia
Primary outcomes
1
Description
insomnia
Timepoint
at baseline, after one month
Method of measurement
Insomnia Severity Index
2
Description
Heart rate variability
Timepoint
at baseline, after one month
Method of measurement
heart monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group first completes sleep dairy for two weeks and then receives a group session (in groups of 2-3) of a one-session cognitive behavioral intervention based on their sleep status and sleep habits.
Category
Treatment - Other
2
Description
Control group: Routine treatments
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Babak Amra
Street address
Soffe St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
amra@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Babak Amra
Street address
Ostandari St.
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3263 8279
Email
amra@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Chancellory of Research, Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan university of medical sciences, Isfahan,iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3060
Fax
Email
Amra@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan university of medical sciences, Isfahan,iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3060
Fax
Email
Amra@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan university of medical sciences, Isfahan,iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 3060
Fax
Email
Amra@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants data will be Shared after being unidentified
When the data will become available and for how long
Six months after the publication of the results
To whom data/document is available
All researchers are allowed to have access to data
Under which criteria data/document could be used
In order to use in Meta-analysis studies
From where data/document is obtainable
A request should be sent to the Chancellery of Research of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
The request will be reviewed in the Chancellery of Research and the Ethics Committee of Isfahan University of Medical Sciences; Data will be delivered upon approval.