Protocol summary

Study aim
Comparison of the effects of Benson relaxation and foot reflexology massage on the quality of sleep in patients with heart failure
Design
This study was a clinical trial with a control group and two blinded blinded study groups. In the case of patients referring to the Cardiology Clinic, randomized assignment with a sample size of 93 and a sample size in each group of 27 with parallel groups The BBR method will be divided into two groups of test and one control group with sixth permutation blocks.
Settings and conduct
This study is a randomized clinical trial. All patients with mild to moderate hemodynamic heart failure who referred to the specialized clinic of Javad Alamea 2 Torbat Heydariyeh are a clinical blinded clinical trial.
Participants/Inclusion and exclusion criteria
Intervention for the studied groups at the beginning of the visit after obtaining informed consent and suitable age, lack of admission to the psychiatric ward, lack of chronic disease, lack of use of sedative medications, lack of history of foot injury, confirmation of diagnosis of heart failure and poor sleep quality. And complete patient alertness are included in the study, and in case of patient dissatisfaction, patient death and any unexpected complications, history of neuropathy and a history of missing patients in the past two months, and compensated for heart failure, they will be excluded from the study phase
Intervention groups
1- Patients who are affected by the relaxation of the Benson method on their sleep quality.2. Patients who are affected by the effect of foot reflexology massage on their sleep quality.3. A control group that only undergoes routine treatment.
Main outcome variables
Improve the quality of sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180528039882N1
Registration date: 2018-06-08, 1397/03/18
Registration timing: prospective

Last update: 2018-06-08, 1397/03/18
Update count: 0
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
Massoomeh Emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5223 6418
Email address
emami.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Benson Relaxation and Foot Reflexology on the Quality of Sleep in Patients with Heart Failure
Public title
Comparison the effect of Benson Relaxation and Foot Reflexology on the Quality of Sleep in Patients with Heart Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Having at least 30 years and maximum 60 years of age No admission to psychiatric wards and no known psychiatric disorders (schizophrenia, anxiety, depression, dementia). Not having chronic disease (cancer, musculoskeletal disorders, chronic renal failure) Have full vigilance and acceptable listening and speaking ability to answer questions and learn the relaxation method. Do not take sedative drugs such as benzodiazepines Having no history of injury, open wounds, and surgery in the legs during the last two years that prevent the massage of the back of the foot. Considering the history, the medical records and the researcher's observation Confirmation of diagnosis of systolic (mild to moderate) heart failure by a specialist who has been ill for at least six months Confirmation of undesirable sleep quality based on Peters Leaf questionnaire (score 5-21 is recognized as undesirable sleep quality) 10. The patient is completely alert and able to answer questions.
Exclusion criteria:
If the patient is unsatisfied, continue to participate in the study Patient's death The occurrence of any unexpected complications during an intervention that prevents the patient from continuing work (arrhythmia, CPR on the patient during an intervention, secondary myocardial infarction, or angioplasty). People with a history of diabetic neuropathy. Phase compensated heart failure entered the unconsolidated phase. Do not have a history of missing loved ones in the past two months.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Random random allocation ,method using balanced block randomization (BBR) ,with 6-point permutational blocks to 2 test groups and 1 control group
Blinding (investigator's opinion)
Single blinded
Blinding description
People who are invited to participate in the study and are classified in intervention groups after being informed consentfully are not aware of the allocation of study groups. Patients are not referred to the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Khorasan Razavi province, Gonabad city, Asian road border
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2018-02-21, 1396/12/02
Ethics committee reference number
IR.GMU.REC.1396.122

Health conditions studied

1

Description of health condition studied
Patients with systolic heart failure (mild to moderate)
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified

Primary outcomes

1

Description
Improve sleep quality based on Peters Leaf questionnaire
Timepoint
Sleep quality measurement before intervention and after intervention, duration of intervention is 3 weeks.
Method of measurement
Petersberg Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, foot-reflecting massage is performed as a non-invasive intervention by hand after preparing the legs, and then the foot-foot reflection massage is done in the foot area at the point of the pinnacle at sixty feet. Before performing the back massage, the palms of the foot in the area At first, a minute of general massage of the foot is performed with the same precursor movements to warm the feet in the patient, and then the foot reflexology of the foot with direct thumb on the respective area of each foot for 15 minutes and a total of 30 minutes. The intervention is conducted 3 times a week for 4 weeks at the clinic by a researcher and researcher
Category
Treatment - Other

2

Description
Intervention group: Relaxation exercises are individually taught to the research units. Subsequently, the instruction manual accompanies a compact disc recorded by the training process or via mobile Bluetooth for home-based training to research units They were asked to perform the exercises for 2 days, for the first time in the morning (between 8-10 o'clock) and 2 o'clock in the evening (between 20 o'clock to 22 o'clock) for 20 minutes for 4 weeks
Category
Treatment - Other

3

Description
Control group: 3. A control group that only undergoes routine treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialty Clinic Javad Alaem 2 Torbat Heydarieh
Full name of responsible person
Massoomeh Emami Bakawali
Street address
8th gharani,gharani st,Specialized clinic of Jawad Alameh 2
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
929516915169
Phone
+98 51 5222 9504
Email
emami.m@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Sajjadi
Street address
Khorasan Razavi - Gonabad, Asian Roads, Research & Technology Dept. of Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
info@hms.gmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
1
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
Gonabad University of Medical Sciences
Full name of responsible person
Massoomeh Emami
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.19;Modarress 24 Street;45Meters Avenue;Torbat Heidari
City
Torbat Heidari
Province
Razavi Khorasan
Postal code
9519656563
Phone
+98 51 5223 6418
Fax
Email
emami.m@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Massoomeh Emami
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.19;Modarress 24 Street;45Meters Avenue;Torbat Heidari
City
Torbat Heidari
Province
Razavi Khorasan
Postal code
9519656563
Phone
+98 51 5223 6418
Fax
Email
emami.m@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Massoomeh Emami
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.19;Modarress 24 Street;45Meters Avenue;Torbat Heidari
City
Torbat Heidari
Province
Razavi Khorasan
Postal code
9519656563
Phone
+98 51 5223 6418
Fax
Email
emami.m@gmu.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
Part of the data, such as information on the main outcome, is shared best practice.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
For research on the topic of study
From where data/document is obtainable
Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
Refer to the publisher site
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