Determination of application of "Roy'a adaptation model" on blood pressure and quality of life of hypertensive patients
Design
This is a quasi-experimental study which includes two groups: intervention and control. Participants were chosen randomly but allocation to the groups was not randomized. Also the study was not blinded. Study included 3 phase: pre-intervention, intervention and post-intervention.
Settings and conduct
The study took place in emergency department of Yazd Heart Center. After sampling blood pressure and quality of life were measured. Roy's adaptation model was applied to the intervention group according to nursing process; whereas there was no intervention in the control group. First participants were assessed by Roy's assessment form. Next nursing diagnoses were determined according to incompatible behavior and stimuli. After that a goal was set for every diagnoses. Then the strategies for reaching the goals were planned. Then the strategies (education, referral, advice, follow up) were implemented. Evaluation was done by the amount of reaching the goals.
Participants/Inclusion and exclusion criteria
Hypertensive patients who were 40 to 60 years old and could read and write. Also physician diagnosed them as hypertensive for at least 2 years.
Intervention groups
The study included two groups: intervention and control. Roy's adaption model was applied in the intervention group whereas there was no intervention in the control group.
Main outcome variables
Reduction of systolic and dyastolic blood pressure, Improvement of quality of life score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041971N1
Registration date:2019-01-20, 1397/10/30
Registration timing:retrospective
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Mahboobeh Khani sanij
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 9013
Email address
khanimah@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
2017-06-05, 1396/03/15
Actual recruitment end date
2017-08-16, 1396/05/25
Trial completion date
2018-02-09, 1396/11/20
Scientific title
The effect of application of "Roy's adaptation model" on blood pressure and quality of life of hypertensive patients
Public title
The effect of application of "Roy's adaptation model" on blood pressure and quality of life of hypertensive patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40-60 years
Being diagnosed as hypertensive patient for at least 2 years
Being able to read and write
Being diagnosed as hypertensive patient by physician
Exclusion criteria:
Admission to hospital during the study
Being absent in more than 2 planned sessions
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tarbiat Modares University
Street address
Nasr, Jalal AleAhmad st.
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.TMU.RES.1395.495
Health conditions studied
1
Description of health condition studied
Hypertnsion
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
Primary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Omron Blood pressure monitor, Model M10-IT
2
Description
Quality of life
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Quality of life questionnaire S-F36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Application of Roy's adaptation model.First of all the participants were assessed by Roy's assessment tool. Maladaptive behavior and stimuli were determined. Then nursing diagnoses and goals were set. Then nursing care plan was set. After that strategies like education, referral, consultation and follow up were implemented. After all the amount of reaching the goals was evaluated.
Category
Lifestyle
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Heart Center
Full name of responsible person
Mahboobe Khani Sanij
Street address
Jomhoori Blvd, Yazd heart center
City
Yazd
Province
Yazd
Postal code
35352-53335
Phone
+98 35 3525 5011
Fax
+98 35 3525 3335
Email
mbkh268@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Yaghoub Fathollahi
Street address
Tarbiat Modares University, Nasr, Jalal AleAhmad st.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
mbkh268@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Dr Zohre Vanaki
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tarbiat Modares University, Nasr, Jalal AleAhmad St.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 982182880000
Email
vanakiz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Zohre Vanaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tarbiat Modares University, Nasr, Jalal AleAhmad st.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
vanakiz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Zohre Vanaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tarbiat Modares University, Nasr, Jalal AleAhmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
vanakiz@gmail.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