The present study aimed to determine the effect of Benson muscle relaxation on level of anxiety and hemodynamic status in patients waiting for diagnostic and therapeutic electrophysiological interventions.
Method: This is a clinical trial study with Inclusion Criterias of Minimum age of 18 years old;ability to communicate verbally;Ability to understand the Persian language and recorded issuea on CD;no hearing problems,muscle paralysis,thyroid function disorders,mental illness(according to the patient's report);no previous history of catheter Ablation;lack of experience and familiarity with similar periods of muscle relaxation;sign a written informed consent; and exclusion criterias of transforming for electrophysiological studies sooner than planned time;the lack of compliance with the timeframe specified for relaxation exercises;any changes in treatment plan such as canceling or delay;using sedative drugs over 5 hours before electrophysiology intervention;lack of training relaxation less than three times or not enough exercise accordance with instructions by patient`s report, that was conducted on patients awaiting for electrophysiological interventions admitted to Heshmat educational-therapeutic center in Rasht. 72 Samples were selected through convenience method and were allocated by random block method into two matched group named intervention (usual care and relaxation) and control (usual care only) groups. Data was collected using a three 3 part questionnaire including personal/clinical data, hospital anxiety and depression scale (only anxiety Part) and hemodynamic chart through interview and records observation and measurement. Personal/clinical data data were collected in 3-5 hours before electrophysiology intervention and anxiety levels and hemodynamic status collected in two-phase of 3-5 hours and 5-60 min before electrophysiology intervention. Intervention group were encouraged to listen to audio instructions of Benson relaxation for 10 minutes using headphones, and exercise it at least 3 times between two steps of study. research assumptions were relaxation affects on anxiety and hemodynamic measures reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403031118N2
Registration date:2015-02-04, 1393/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Mojgan Baghaie Lakeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 1185
Email address
baghaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social Determinants Of Health Research Center
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson muscle relaxation techniques on anxiety and hemodynamic status in Patients undergoing electrophysiologic interventions
Public title
Effect of Benson muscle relaxation techniques on anxiety and hemodynamic status in Patients undergoing electrophysiologic interventions in Dr. Heshmat hospital in Rasht, 2013
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria :Hospitalized patients foe electrophysiologic interventions with at least age of 18 years old;ability to communicate verbally;Ability to understand the Persian language and recorded issues on CD;no hearing problems,muscle paralysis,thyroid function disorders,mental illness(according to the patient's report);no previous history of catheter Ablation;lack of experience and familiarity with similar periods of muscle relaxation;sign a written informed consent
Exclusion criteria : transforming for electrophysiological studies sooner than planned time;the lack of compliance with the time frame specified for relaxation exercises;any changes in treatment plan such as canceling or delay;using sedative drugs over 5 hours before electrophysiology intervention;lack of training relaxation less than three times or not enough exercise accordance with instructions by patient`s report.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Guilan University of Medical Science
Street address
ُShahid Beheshti Bolv, Guilan University of Medical Science
City
Rasht
Postal code
4193875371
Approval date
2014-03-17, 1392/12/26
Ethics committee reference number
2920452602
Health conditions studied
1
Description of health condition studied
Arrhytmia
ICD-10 code
147-148
ICD-10 code description
Paroxysmal tachycardia-Atrial fibrillation and flutter
Primary outcomes
1
Description
reduction of anxiety mean score
Timepoint
Two-stage with at least 2 hours apart
Method of measurement
Interview by Using a HAD questionnaire
Secondary outcomes
1
Description
reduction of hemodynamic measures mean
Timepoint
Two stages with at least 2 hours apart
Method of measurement
measurement and Record on special hemodynamic parameters form chart
Intervention groups
1
Description
The intervention groups: the intervention group will ask for listening a 7-minute relaxation training Audio CD prepared by a qualified professional by a headphone in about 3 -5 hours before performing the electrophysiologic study and practice the technique in accordance with instructions in the tape , at least 3 times with 45 minutes apart under researcher supervision. until 15-60 minute befor procedure
Category
Prevention
2
Description
Control group: This group will receive only routine care provided by healt care team in 3-5 hours before electrophysiologic intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Theraputic educational center of DR Heshmat
Full name of responsible person
Mojgan Baghaie Lakeh
Street address
Theraputic educational center of DR Heshmat, Imamkhomeini ST,
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University Of Medical Science,Rasht,Iran.
Full name of responsible person
Mojgan Baghaie Lakeh
Street address
Social Determinants Of Health Research Center, Nursing & Midwifery Coledge, Daneshju St,, Shahid Beheshti BOLV,
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Determinants Of Health Research Center, Guilan University Of Medical Science,Rasht,Iran.
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
Social Determinants Of Health Research Center, Guilan University Of Medical Science,Rasht, Iran
Full name of responsible person
Mojgan Baghaie Lakeh
Position
Master degree. Faculty Member
Other areas of specialty/work
Street address
Social Determinants Of Health Research Center, Nursing and midwifery college, Daneshjoo Str, Shahid Beheshti Bolv.