Objectives: To assess the effect of Benson relaxation method on anxiety and hemodynamic status of patients before surgery Design: A randomized clinical trial Setting and conduct: All patients who are candidate for angiography, angioplasty, coronary artery bypass graph, or abdominal surgery who refer to Ekbatan or Beasat hospitals in Hamadan city will be enrolled in to the trial if they are eligible. Inclusion and exclusion criteria: The patients of 18 to 65 years of will be enrolled. Patients who have any one of the following problems will be excluded: (a) hearing loss; (b) muscle paralysis; (c) known psychiatric disease; (d) negative history of previous muscle relaxation; (e) understanding Persian language; (f) no addiction to narcotic, sedative, or alcohol. Intervention: Routine pre-operative medications and procedures plus listening to audio files for half an hour using Benson relaxation method through headphones an hour before surgery. Control: Routine pre-operative medications and procedures only. Primary outcome: Measuring anxiety using the Hospital Anxiety Inventory consists of seven questions based on the four-choice Likert’s scale (scoring of 0 to 3) with a minimum score of zero and a maximum score of 21. Mean score of 0-7 means no anxiety; 8-10 means intermediate anxiety; and 11 or above means a suspected anxiety disorder. The anxiety was evaluated in the patients 8 to 12 hours before the intervention and a half an hour before the surgery. Secondary outcome: The secondary outcomes of interest include: (a) measuring systolic and diastolic blood pressure using a heart monitoring device, 8 to 12 hours before the intervention and a half an hour before surgery; (b) measuring heart rate pressure using a heart monitoring device, 8 to 12 hours before the intervention and a half an hour before surgery; (c) measuring respiratory rate pressure using a heart monitoring device, 8 to 12 hours before the intervention and a half an hour before surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312249014N19
Registration date:2014-01-06, 1392/10/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-06, 1392/10/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson relaxation method versus no intervention on anxiety and hemodynamic status of patients before surgery: a randomized clinical trial
Public title
Effect of Benson relaxation method versus no intervention on anxiety and hemodynamic status of patients before surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion and exclusion criteria: The patients of 18 to 65 years of will be enrolled. Patients who have any one of the following problems will be excluded: (a) hearing loss; (b) muscle paralysis; (c) known psychiatric disease; (d) negative history of previous muscle relaxation; (e) understanding Persian language; (f) no addiction to narcotic, sedative, or alcohol.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
P/16/35/9/2933
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Measuring anxiety
Timepoint
8 to 12 before the intervention and half an hour before the surgery
Method of measurement
Using the Hospital Anxiety Inventory consists of seven questions based on the four-choice Likert’s scale (scoring of 0 to 3) with a minimum score of zero and a maximum score of 21. Mean score of 0-7 means no anxiety; 8-10 means intermediate anxiety; and 11 or above means a suspected anxiety disorder
Secondary outcomes
1
Description
measuring systolic and diastolic blood pressure
Timepoint
8 to 12 before the intervention and a half hours before surgery
Method of measurement
using a heart monitoring device
2
Description
measuring heart rate pressure
Timepoint
8 to 12 before the intervention and a half hours before surgery
Method of measurement
using a heart monitoring device
3
Description
measuring respiratory rate pressure
Timepoint
8 to 12 before the intervention and a half hours before surgery
Method of measurement
using a heart monitoring device
Intervention groups
1
Description
Routine pre-operative medications and procedures plus listening to audio files for half an hour using Benson relaxation method through headphones an hour before surgery
Category
Prevention
2
Description
Routine pre-operative medications and procedures only