The aim of this study is to evaluate the effect of back massage on vital signs and anxiety in patients with essential hypertension.This study is a randomized clinical trial in the city of Shiraz, Imam Reza the clinic will be on 90 patients with primary hypertension eligible.Patients randomly assigned enter an intervention or control group and Intervention group back massage the neck and back (shoulders to waist) will be done for 10 minutes and the control group will rest for 10 minutes.Inclusion criteria: Age between 30 to 70 years ؛ History, is not of blood pressure drop skin disorders and spine؛ Non Anti-anxiety drugs and sedative؛ The absence of diabetes and hypertension disease (kidney problems, adrenal gland tumors, congenital heart defects) is effective.Exclusion Criteria: Back pain due to spinal cord injury, herniated or degenerating discs؛ Patients who have undergoing surgery lumbar؛ No Inclusion criteria.Study population and sample size in this study:will be evaluated 90 patients with essential hypertension.Intervention: The intervention group, back massage done for 10 minutes, 2 sessions a week for 6 weeks.The control group, patients rested for 10 minutes a week doing 2 sessions of for 6 weeks.The primary outcome variables: back massage and stress influence on the vital signs of patients with essential hypertension.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112615552N1
Registration date:2014-02-23, 1392/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Mehdi Moghadasi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 2444 0402
Email address
moghadasi_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-07-08, 1392/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage on anxiety and vital signs of patients with primary hypertension
Public title
Effect of back massage on Vital signs and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30 to 70 years ؛ History, is not of blood pressure drop skin disorders and spine؛ Non Anti-anxiety drugs and sedative؛ The absence of diabetes and hypertension disease (kidney problems, adrenal gland tumors, congenital heart defects) is effective.Exclusion Criteria: Back pain due to spinal cord injury, herniated or degenerating discs؛ Patients who have undergoing surgery lumbar؛ No Inclusion criteria.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization is done with table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
The central building of of Shiraz Medical University,St, Haft Tir, Zand Street .
City
Shiraz
Postal code
7134814336
Approval date
2013-05-15, 1392/02/25
Ethics committee reference number
88-6603
Health conditions studied
1
Description of health condition studied
essential hypertension.
ICD-10 code
I10-115
ICD-10 code description
Diseases of the circulatory system
Primary outcomes
1
Description
blood pressure
Timepoint
blood pressure before and after the intervention, 2 times a week for 6 weeks and three days after the intervention was measured .
Method of measurement
blood pressure With Digital manometer-mmHg
2
Description
Anxiety
Timepoint
the level of anxiety before the first session and after the first session, after the third week, after six weeks and three days after the intervention, was measured
Method of measurement
Spielberger form
3
Description
heart rate
Timepoint
heart rate before and after the intervention, 2 times a week for 6 weeks and three days after the intervention was measured.
Method of measurement
per minute
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will rest for 5 minutes then will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،Then in the intervention group, after applying an oily substance (sesame oil) 10 min back massage done of the neck and the back (from shoulder to waist)،back massage will be done 2 times a week for 6 weeks for patients ،Then vital signs will be measured after a 10 minute massage, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention.
Category
Behavior
2
Description
The Control group will rest for 5 minutes then will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،in the control group, patients will rest 10 minute ،Then vital signs will be measured after a 10 minute rest, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Specialty and Subspecialty Imam Reza
Full name of responsible person
Mehdi Moghadasi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy Shiraz University
Full name of responsible person
Dr. Ali Poostforoosh
Street address
Fifth Floor, Shiraz University of Central Building, Boulevard Jame Jam, Shiraz .
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Moghadasi
Position
Senior nursing student
Other areas of specialty/work
Street address
No. 6, Gulshan Lane 4 , Street 15 meters Kaveh
City
Borojerd
Postal code
Phone
+98 66 2444 0402
Fax
Email
mehdimoghadasi99@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
PhD student
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
mohebbi04@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Moghadasi
Position
Senior nursing student
Other areas of specialty/work
Street address
No. 6, Street 15 meters Kaveh
City
Borojerd
Postal code
69187-84377
Phone
+98 66 2444 0402
Fax
Email
mehdimoghadasi99@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)