Protocol summary

Summary
The present study is aimed to investigate the effectiveness of mindfulness-based stress reduction (MBSR) on perceived stress and blood pressure of patients suffering from high blood pressure. The research has a pretest-posttest quasi-experimental design. The research population consists of all patients with high blood pressure, among whom 30 participants were selected using the convenience sampling method. Then, they were randomly divided into two experimental and control groups (each with 15 participants). The inclusion criteria were suffering from high blood pressure, diagnosed by a cardiologist, being in the age range of 30 to 50 years old, being female, and not suffering from any physical and psychological disorder. The experimental group received 8 mindfulness-based stress reduction treatment sessions by a clinical psychologist. The study included two phases of pretest and posttest. The process of assessment in the present research was conducted by a trained assessor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070126600N1
Registration date: 2016-07-01, 1395/04/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Elahe khosravi
Name of organization / entity
Islamic Azad Najafabad
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 5394
Email address
ghorbani_psyc@pnu.according.ir
Recruitment status
Recruitment complete
Funding source
My self
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness-based stress reduction on Perceived Stress and blood pressure in hypertension
Public title
Effectiveness of mindfulness-based stress reduction on Perceived Stress and blood pressure in high blood pressure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female patient 30 to 50 having primary blood pressure systolic (140-180) and diastolic (90-110). Exclusion criteria: without special illness that need medication or a special diet such as Diabetes, the absence of more than two sessions..
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
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
Najafabad Islamic Azad University Ethics Committee
Street address
Islamic Azad University, Najafabad, Esfahan.
City
Najafabad
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.MUI.REC.1394.4-414

Health conditions studied

1

Description of health condition studied
High blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertention

Primary outcomes

1

Description
Percieved Stress
Timepoint
Before and two month after intervention
Method of measurement
Cohen percieved stress questionnaire

2

Description
Blood pressure
Timepoint
Before and two month after intervention
Method of measurement
Mercury tonometer

Secondary outcomes

1

Description
Persons motivation to continue the treatment
Timepoint
Before and two month after starting the intervention
Method of measurement
Intervention

Intervention groups

1

Description
Control group: do not receive any training
Category
Treatment - Other

2

Description
Intervention group: Experimental group received eight weekly session MBSR treatment, each session was 45 minutes. First session: Referrals and familiarity with member of the group-Express the concept of stress and their effect on blood pressure. Disease-providing treatment and pre-test logic and techniques eat raisins. Session Two: Presentation scan exercise - any sitting meditation exercise. Third session: Seeing and hearing training exercise. Session Four: Along with breathing meditation - body sounds and thoughts. Fifth Session: Sitting meditation - stress management training. Sixth Session: three-minute breathing space training-practice people think-meditation exercise. Seventh session: analytical meditation Four dimensional meditation - awareness training to alert the moment - Analysis of life events. Eighth Session: Body scan-practice three-minute breathing space- talk about coping with training.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Torkan Heart Clinic.
Full name of responsible person
Street address
Shariati Avenue, Esfahan.
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Najafabad Islamic Azad University
Full name of responsible person
Elahe khosravi
Street address
Islamic Azad University, Najafabad, Esfahan.
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Najafabad Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Najafabad Islamic Azad University
Full name of responsible person
Elahe khosravi
Position
MA
Other areas of specialty/work
Street address
Islamic Azad University, Najafabad, Esfahan.
City
Esfahan
Postal code
Phone
+98 31 3651 5394
Fax
Email
E_kh1980@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
PNU Najafabad Branch
Full name of responsible person
Maryam Ghorbani
Position
P.H.D
Other areas of specialty/work
Street address
PNU Branch, Najafabad, Esfahan.
City
Najafabad
Postal code
Phone
+98 31 3651 5394
Fax
Email
Ghorbani_psyc@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Najafabad Islamic Azad University
Full name of responsible person
Elahe khosravi
Position
MA
Other areas of specialty/work
Street address
332 ,Andish 3, Andish Apartment, Ghadir Blv, Sepahan Shahr, Esfahan.
City
Esfahan
Postal code
8179943433
Phone
+98 31 3651 5394
Fax
Email
E_kh 1980@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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