Protocol summary

Study aim
Determining the effect of diaphragmatic breathing technique training along with range of motion exercises using animation on the sleep quality of heart failure patients
Design
Randomized controlled clinical trial, with parallel groups, second phase, without blinding, number of 110 patients using permutation blocks of 4 using Excel software.
Settings and conduct
The setting of this research will be the heart specialist office and the cardiac wards of Emam Reza and Ghaem hospitals in Mashhad. In the intervention group, the researcher asks the patient to watch the animation and perform the exercises based on it in the presence of the researcher, then the patient is asked to complete the sleep quality questionnaire in the first morning and then twice a day for one month. Do diaphragmatic breathing techniques and range of motion exercises (shoulder, hip, and knee) in bed an hour after breakfast and at night before going to bed. And every day in the evening, every hour as desired, at least one hour after lunch for 15 minutes to walk at a slow pace. In the control group, patients will receive face-to-face training from nurses and the use of the department's educational pamphlets.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 30 and 80, 54>EF>35, Class 1 and 2 heart failure Exclusion criteria: Suffering from a mental disorder Suffering from COPD or any lung disorder Suffering from joint and muscle diseases
Intervention groups
Intervention group: using the diaphragmatic breathing technique along with range of motion exercises using animation for a period of one month twice a day along with a 15-minute walk. Control group: receiving the usual face-to-face training of nurses and prepared pamphlets
Main outcome variables
quality of sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220803055605N1
Registration date: 2022-09-05, 1401/06/14
Registration timing: registered_while_recruiting

Last update: 2022-09-05, 1401/06/14
Update count: 0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
massomeh abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3389 0169
Email address
abbasims3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diaphragmatic breathing technique training along with range of motion exercises using animation on the sleep quality of heart failure patients
Public title
The effect of diaphragmatic breathing technique training along with range of motion exercises using animation on the sleep quality of heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age ranges between 30 and 80 45<EF>35 Class 1 and 2 Heart failure According to doctor
Exclusion criteria:
Suffering from muscle and joint disease Existence of obvious shortness of breath during physical or breathing exercises Having COPD or any pulmonary disorder Lack of co - ordination with more than 50 % of the total number of practice sessions Mental disorders require medical treatments
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
In order to perform randomization in this study, first, using Excel software, 30 randomized permutation blocks of 4 pieces (using two characters A, B) will be retrieved. A will be considered for the intervention group and B for the control group. Then, by using 30 sealed envelopes, each of the randomized blocks will be placed in each envelope. After obtaining informed consent from each patient, if they meet the inclusion criteria,by refering to the sealed envelopes and based on any random character, the patient will be randomized to intervention or control group.Then the next envelope will be used. This process will be continued until 110 patients randomly placed in two intervention and control groups. To prevent the error,the researcher ask the office secretary to refer to the closed envelopes and report the random digits order.
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
Daneshgah Street, Ibne Sina Avenue, School of Nursing and Midwifery,Mashhhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
3944-91388
Approval date
2022-08-01, 1401/05/10
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.054

Health conditions studied

1

Description of health condition studied
Heart failure patients
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Sleep quality
Timepoint
Three times a day, Morning, Noon, And night
Method of measurement
Petersburg Sleep Quality Questionnaire

Secondary outcomes

1

Description
Investigating the sleep quality of heart failure patients
Timepoint
Morning. Noon. Night
Method of measurement
Sleep quality questionnaire

Intervention groups

1

Description
Intervention group: First, in the present study, based on the search of literature and the opinion of experts, the diaphragmatic breathing technique and joint range of motion movements will be converted into two 5-minute animation films with the help of a professional animator. Then, in the intervention group, the researcher first asks the patient to watch the animation and perform the exercises based on it in the presence of the researcher. and then perform diaphragmatic breathing techniques and range of motion exercises (shoulder, hip, and knee) in bed twice a day for one month, one hour after breakfast and at night before going to bed. And every day in the evening, every hour as desired, at least one hour after lunch for 15 minutes to walk at a slow pace. Finally, after one month of exercises at home, the sleep quality questionnaire will be completed online by the patient and will be provided to the researchers.
Category
Rehabilitation

2

Description
Control group: In the control group, patients will receive face-to-face training from nurses and the use of the department's educational pamphlets. Finally, after one month, the patients are asked to complete the sleep quality questionnaire again
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyyedi Medical Clinic, Emam reza Hospital
Full name of responsible person
Masomeh Abbasi
Street address
Daneshgah street, Ibn Sina avenue, Nursing and Midwifery School
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 905 532 0763
Email
abbasims3@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Street address
Daneshgah Street, Ibne Sina avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
aghebatin@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
Nahid Aghebati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah Street, Ibne Sina Avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3859 1511
Email
aghebatin@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Position
Associate profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah Street, Ibne Sina Avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
aghebatin@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MasomehAbbasi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah Street,Ibne Sina Avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3389 0169
Email
abbasims3@mums.ac.ir

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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