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The effect of sleep hygiene training on sleep quality and blood pressure in patients with blood pressure and sleep disorders

Protocol summary

Study aim
The relationship between sleep hygiene and blood pressure control
Design
Clinical trial with control group, with parallel groups, randomized, phase 2-3 on 86 patients. spss software was used for randomization.
Settings and conduct
86 patients were selected in Ibn Sina Health Center of Isfahan. Blood pressure of patients following the principles of standard measurement (not using stimulants and caffeinated compounds half an hour before the measurement, the selected arm is bare and free of scars, lymphedema or arteriovenous fistula, at least 5 minutes before in a sitting position so that the legs and waist fully in contact with the ground and the seat, the brachial artery is parallel to the heart and the length and width of the blood pressure cuff are 80% and 40% of the circumference of the arm, respectively) was measured using a Mark Richter hand sphygmomanometer made in Germany. Demographic characteristics including age, gender, height, weight, education and occupation of each patient were recorded. Blood pressure measurement and completion of the Petersburg questionnaire were done before the intervention, one and three months after intervention in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient consent to enter the study Age range from 30 to 70 years Suffering from high blood pressure Exclusion criteria: Having a severe physical or mental illness, addiction, pregnancy
Intervention groups
We have two groups of 43 people, educational intervention and control. For the intervention group, 4 training sessions were held based on sleep hygiene education and its relationship with blood pressure control.
Main outcome variables
Blood pressure, sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220119053760N3
Registration date: 2023-12-04, 1402/09/13
Registration timing: retrospective

Last update: 2023-12-04, 1402/09/13
Update count: 0
Registration date
2023-12-04, 1402/09/13
Registrant information
Name
Neda Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8089
Email address
n.abrishami@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
2020-08-20, 1399/05/30
Actual recruitment end date
2020-08-20, 1399/05/30
Trial completion date
2020-08-20, 1399/05/30
Scientific title
The effect of sleep hygiene training on sleep quality and blood pressure in patients with blood pressure and sleep disorders
Public title
The relationship between sleep hygiene and blood pressure control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to enter the study Age range from 30 to 70 years Patients who, according to the latest guidelines of the Ministry of Health and Medicine, have been diagnosed with high blood pressure or had uncontrolled blood pressure (blood pressure ≤ 90.140 mmHg) despite taking medication.
Exclusion criteria:
Severe physical or mental illness addiction pregnancy
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 86
Actual sample size reached: 86
Randomization (investigator's opinion)
Randomized
Randomization description
First, among the clients of Ibn Sina Center in Isfahan city, 86 clients who had high blood pressure (≥140/90) and had a medical record in the center were selected and included in the study. Patients eligible to enter the study received a code in order of entry (from number 1 to number 86), then using these codes and using SPSS software, they were assigned to two groups of 43 people, intervention and control (spss/data/ selected cases). Allocation of patients into two intervention and control groups was done in a simple random manner. The study was not blinded. The randomization unit is individual.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.MUI.MED.REC.1398.005

Health conditions studied

1

Description of health condition studied
blood pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

Primary outcomes

1

Description
sleep quality
Timepoint
before, one month and three months after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

2

Description
blood pressure
Timepoint
before, one month and three months after the end of the intervention
Method of measurement
With the help of a mercury pressure gauge

Secondary outcomes

empty

Intervention groups

1

Description
43 patients with high blood pressure were trained as follows during four training sessions of 60-75 minutes: Session 1: Defining sleep and explaining the mechanism of sleep and wakefulness, presenting materials related to relaxation techniques to enter a peaceful and pleasant sleep in accordance with the principles of sleep hygiene.Session 2: Explaining the relationship between sleep and blood pressure, examining physiological changes in sleep and sleep disorders in simple language, explaining and interpreting 10 principles of sleep hygiene. Session 3: Investigating the effect of age on sleep, introducing the components of sleep and a brief explanation regarding factors that disrupt sleep (such as sound, light, etc.) and improve it (earmuffs, blindfolds, dark and silent places, etc.) ), explanation and interpretation of 13 items from the principles of sleep hygiene. Session 4: Summarizing and reviewing the trainings of the previous sessions and the necessity of adhering to the application of the taught items and timely referrals at one-month and three-month intervals to measure blood pressure and complete the Petersburg Sleep Quality Questionnaire.The educational method included lectures, questions and answers, and discussions in small groups.The sleep quality assessment method was through the Pittsburgh Sleep Quality Index, which was completed before, one month, and three months after the completion of the training. The Petersburg Sleep Quality Questionnaire is a report that examines sleep quality over the past month. This questionnaire has 19 questions with 4 options and contains 9 sections to examine the dimensions of mental quality of sleep, delay in falling asleep, sleep duration, sleep efficiency, sleep disorders, use of sleeping pills, daily dysfunction.
Category
Lifestyle

2

Description
Control group: They did not receive any training intervention. Their blood pressure was measured before, one month and three months after completing the training. The Pittsburgh Sleep Quality Questionnaire was also completed before, one month and three months after the completion of the training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Health Center, Isfahan
Full name of responsible person
Parastoo Golshiri
Street address
Ibn Sina St
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
golshiri@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@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
90
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
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.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
All data can be shared after de-identification, 6 months after publication of the article.
When the data will become available and for how long
Information can be shared 6 months after the publication of the article.
To whom data/document is available
physicians
Under which criteria data/document could be used
The information of this study can be used by doctors, internal specialists, endocrinologists, psychologists and researchers in the field of non-pharmacological interventions. In this regard, if researchers consider comparing another educational or therapeutic method with the present method, or if they examine the sample of patients other than those with blood pressure but with sleep disorders, they can benefit from the results of our study.
From where data/document is obtainable
Send email to: golshiri@hlth.mui.ac.ir Belongs to Dr. Prasto Golshiri, Faculty of Medicine, Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send email to: golshiri@hlth.mui.ac.ir
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