The aim of this study is to evaluate the effect of massage therapy on anxiety levels of patients undergoing cardiac Electro-Physiology، This study is a clinical trial with control conducting in Shahid Faghihi and Kowsare hospital affiliated with Shiraz University of Medical Sciences from Nov، 2016 to Jan، 2016 ، Eighty eligible patients candidate for Cardiac Electrophysiology after having obtained the written consent included in study، The patients are selected by convenience sampling and then they are randomly allocated to experimental and control groups، The level of state and trait anxiety were assessed using the Spielberger questionnaire in the all patients before the procedure ، The patients in the experimental group receive back massage for 20 minutes، Then after 10 minutes of massage the patient’s anxiety level is measured، Finally the anxiety levels of patient before and after the intervention are compared، During this time control group will receive the usual care and questionnaire was completed by them two times in 30 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410278505N11
Registration date:2017-01-25, 1395/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research affairs
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of massage therapy on anxiety of patient’s undergoing Electro-Physiology
Public title
The Effect of therapeutic massage on anxiety of patient’s undergoing cardiac Electro-Physiology
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research،
The Cardiologist has recognized the necessity of undergoing Electrocardiography،
Ability to read and write، Having Hemodynamic stability،
Age more than 15 years old،
Obtaining 31 points or higher from Spielberger anxiety questionnaire
Exclusion criteria:
History of a known mental illness or taking psychiatric drugs،
History of participation in training courses of problem solving skill and stress Management:
History of new crisis such as death of first degree relatives،
Divorce of the patient or his/her parents in the last 6 months،
Suffering from hearing lossr،
Taking sedative and analgesic drugs three hours before the intervention،
Drug addiction،
Having pain the pre-procedure pain ،
Reluctance and unwillingness to tacking massage.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Zand Blvd، 7 th floor, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.SUMS.REC.1395.58
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48.1
ICD-10 code description
Persistent Atrial Fibrillation
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and after 10 minutes of massage
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group receives routine care
Category
Lifestyle
2
Description
Massage is done in intervention group in period 20 minutes before the procedure