Comparison of the effect of Benson relaxation and back massage methods on anxiety in patients undergoing cardiac angiography
Design
Clinical trial has two intervention groups and a control group. The sample size of the study was calculated using Torabi et al.'s research and the formula for determining the sample size and considering a 10% drop, 35 people were calculated for each group. Therefore, the total sample size of the research will be equal to 105 people. Sampling will be random-block type.
Settings and conduct
Research environment:
Cardiac Intensive Care Unit of Namazi and Faghihi Hospitals affiliated to Shiraz University of Medical Sciences
Research community:
All angiography candidates referred to Namazi and Faghihi hospitals affiliated to Shiraz University of Medical Sciences
This study is a block-randomized clinical trial in which the mean scores of anxiety, blood pressure, pulse rate and respiration in the three groups of Benson relaxation, back massage and control group are examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Ability to communicate with the patient
• Be at least 18 years old or older
Absence in acute conditions of the disease
No hearing problems and muscle paralysis
• Do not prohibit touching with a doctor's opinion
• No cognitive and mental disorders
• Only undergo an angiography plan
Do not use drugs, sedatives and alcohol before angiography without a doctor's prescription
Exclusion criteria:
• Acute physical condition of the patient
• Patient dissatisfaction and desire to continue massage therapy or muscle relaxation
Intervention groups
For one group of intervention groups, Benson relaxation method will be taught and for the other group, back massage will be performed. No intervention is performed for the control group.
Main outcome variables
Anxiety_Blood pressure_Pulse rate _ Breathing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054435N1
Registration date:2022-06-26, 1401/04/05
Registration timing:prospective
Last update:2022-06-26, 1401/04/05
Update count:0
Registration date
2022-06-26, 1401/04/05
Registrant information
Name
Parvin Moradikashkoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 2163
Email address
parvinmoradi798@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the comparative effect of Bensons Relaxation and Back Massage on Anxiety in patients undergoing Coronary Angiography
Public title
The effect of Benson relaxation and back massage on anxiety in angiography patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's ability to communicate
Be at least 18 years old or older
Absence in acute conditions of the disease
Do not prohibit touching with a doctor's opinion
Only undergo an angiographic plan
Do not take drugs, sedatives and alcohol before angiography without a doctor's prescription
Exclusion criteria:
Hearing problems and muscle paralysis
Cognitive and mental disorders
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple block randomization with block size 6 will be used to place patients in the three groups (massage by the a professional, Benson relaxation technique, and control group). For this purpose, in each block of 6, 2 items will be randomly assigned to the Benson intervention group, 2 items to the massage group and 2 items to the control group. Then, for the next 6 patients, it will be decided randomly in the next block that each patient should be assigned into which group. This process will be proceeded for the next 6 patients until the required number of participants are sampled for the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Codes assigned to patients in three groups will be kept in sealed envelopes and provided to the ward secretary. Patients will not know about these codes. Moreover, the statistician won't be aware of the participants' group.
Placebo
Not used
Assignment
Single
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
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.048
Health conditions studied
1
Description of health condition studied
Cardiac angiography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Measurement of anxiety before the intervention and half an hour after the intervention
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Benson relaxation: In this group, before the intervention, vital signs including blood pressure, pulse rate and respiration are measured using the equipment in the ward, the correctness of which has already been checked. The patient is then placed in a quiet, supine position and closed his eyes when the patient's private environment is provided. The patient receives non-verbal music with headphones and tries to relax his muscles from the toes to the head and then relax, and the patient is instructed to try to do this piece by piece and While tightening and relaxing the muscles, visualize them in your mind and breathe through your nose, and while breathing, listen to the breathing sounds and repeat a word. This takes 15 to 20 minutes.
Category
Behavior
2
Description
Intervention group: Back massage: Participants will be asked to lie on their backs and unveiled around the bed for patient privacy during the intervention. Also, for male patients, massage will be performed by a male massager and for female patients by a female massager. During the massage, sheets will be stretched on the patient and he will be stripped step by step. The massager, who has already received the necessary training, first warms his hands and soaks them in almond oil. Then massage the back for 20 minutes for the patient. Massage is done by static massage, superficial stretching technique, stretching massage, lymphatic surface emptying technique, transverse rubbing technique, and myofascial release technique, which is performed with efflux (gentle pressure and immersion of the body in oil). Study outcome variables are vital signs (respiration rate, pulse rate and blood pressure) and anxiety, which will be assessed using calibrated devices and the Spielberger Anxiety Inventory.
Category
Treatment - Devices
3
Description
Control group: No intervention: They will not receive any intervention and will only be provided with routine nursing training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Ahmad Hosseinzadeh
Street address
Shiraz, Zand St., Namazi Square, Namazi Educational and Medical Center
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱-۷۱۹۳۶
Phone
+98 71 3647 4332
Fax
Email
nemazee_inf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Seyed Mohammad Kazem Tadayon
Street address
Shiraz - Karim Khan Zand Boulevard - next to the medical school
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3235 1087
Fax
Email
FaghihiHsp@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Vahid Hoseini
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3481 4336
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeid Najafi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shiraz University of Medical Sciences, Hazrat Fatemeh School of Nursing and Midwifery, Department of Internal Medicine, Surgery and Emergency Medicine
City
Shiraz
Province
Fars
Postal code
1978-71345
Phone
+98 74 3254 3071
Email
najafisa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeid Najafi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shiraz University of Medical Sciences, Hazrat Fatemeh School of Nursing and Midwifery, Department of Internal Medicine, Surgery and Emergency Medicine
City
Shiraz
Province
Fars
Postal code
1978-71345
Phone
+98 74 3254 3071
Email
najafisa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Parvin Moradikashkoli
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square Namazi Hospital, Nursing School,Shiraz Town
City
Shiraz
Province
Fars
Postal code
1978-71345
Phone
+98 74 3323 2163
Fax
Email
parvinmoradi798@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available