This study is a randomized clinical trial which will be done in Imam Khomeini(ra) Hospital Poldokhtar related to Lorestan University of Medical Sciences. The objectives of this study are to determine and compare the effects of Benson relaxation and slowe stroke back massage on the level of anxiety and vital signs among unstable angina patients admitted to CCU wards; therefore 114 patients with unstable angina randomly divided into 3 different groups ( 38 people in each group). Before any intervention, anxiety, and vital signs of patients in each group were measured and recorded and then intervenetion done (Benson relaxation for 20-15 minutes and masage for 10 minutes in the first two days of hospitalization) in the two groups. In the control group no such intervention performed. After intervention, the severity of anxiety and the vital signs would be measured and recorded . the results will be compared and analysed in three groups .
Data collection tool is a questionnaire.Which consists of three parts
(demographic data, test anxiety Spielberger ,Check list vital signs).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205139737N1
Registration date:2012-05-31, 1391/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-31, 1391/03/11
Registrant information
Name
Zeinab Ahmadipour
Name of organization / entity
Lorestan University of Medical Ssciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0147
Email address
ahmadipourz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Ssciences
Expected recruitment start date
2012-05-25, 1391/03/05
Expected recruitment end date
2012-09-26, 1391/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Benson relaxation and slowe stroke back massage behind level of anxiety and vital signs unstable angina patients.
Public title
Comparison the effect of Benson relaxation and slowe stroke back massage behind level of anxiety and vital signs unstable angina patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 75-18 years old; interest in massage and relaxation program participation; lack of physical illness that Masazhslamt endanger a person's spinal cord injury or surgery such as history; not having psoriasis (burn) bones (fractures) entered into the neck, back and sacrum; lack of drug and alcohol addiction; lack of corporate programs of relaxation; massage and similar techniques, lack of psychological problems (delirium, etc.); no history of hospitalization in CCU and no action Apart from anti-anxiety routine interventions (opioids and benzodiazepines) to create peace. Exclusion criteria: lack of patient cooperation and withdrew from the intervention; unstable conditions according to the patient's physician and any complications that arise during massage therapy or health-threatening.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
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
Lorestan University of Medical Ssciences Ethics Committee
Street address
Khorram Abad road km 5 - Boroujerd - opposite the village Kahrizak - Integrated Medical Sciences
City
Poldokhtar
Postal code
6851836865
Approval date
2012-05-13, 1391/02/24
Ethics committee reference number
66375/200
Health conditions studied
1
Description of health condition studied
Unstable angina
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
Anexity
Timepoint
Before and immediately after intervention
Method of measurement
Spielberger questionnaire
2
Description
Vital signs
Timepoint
Before and immediately after intervention
Method of measurement
Heart monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Before intervention to 15 minutes on goals, the length of study, how Benson relaxation and massage, and their effects on anxiety and overall appearance of life, clarifications necessary separately to each unit of study is given and after obtaining consent, the questionnaire personal information is collected through interviews with patients and medical records. The level of anxiety by Spielberger anxiety questionnaire and through interviews with patients by trained research associate who is a nurse (other than the researcher or user intervention) is determined The vital signs
(systolic and diastolic blood pressure, pulse, respiration) and examined by using electronic heart monitoring device SAADAT models by caliber engineer medical equipment, in three groups by the research partners, will review and ensure the reliability intera observer is involved in the massage group, massage therapy can be administered by a trained researcher.(ICC), confirmed it in writing to the Scientific Advisor to be announced Inter class correlation (ICC), confirmed it in writing to the scientific Advisor to be announced. Massage using massage oil and warm hands in a day and time period
10 minutes in the first 2 days of hospitalization, in the absence of patient privacy will be maintained within the coronary care unit.
Category
Other
2
Description
Relaxation group,first individually and face to face how to do Relaxation training then the researcher to practice your Relaxation process the client performs and the client was asked that same day to do a Relaxation time,which lasts 15-20 minutes intervention also about 20 minutes first 2 days of hospitalization ,is done. Benson Relaxation skills conducted a researcher in the samples using four criteria,each of which is 2 point will be assessed these criteria included being a quiet place ,close your eyes,breathe slow and motionless limbs were being if the samples 7 points from 8 points to gain the necessary skills in applyng the huge intervention after learning points and relaxation by the patient ,the level of anexety and the patients vital signs review and will be recorded.
Category
Other
3
Description
Standard treatment is usually performed in the control group And you have not done any kind of intervention And only 15 minutes from their anxiety and changes in vital signs are measured