Comparison of combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety in patients with Acute Coronary Syndrom
Comparison of combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety in patients with Acute Coronary Syndrom
Design
Four groups clinical trials, With a control group, Randomized by senary random block with no permutations with 64 patient
Settings and conduct
64 Patients referring to the cardiac care units of the Shahid Rajaee hospital of Gachsaran, through continuous sampling will enter to study. The Benson relaxation method will be performed by the patient on the day after the training.Instructions for doing these steps will be provided through the audio file by the researcher. The warm Foot baths will perform up to 10 cm above the ankle with 40 ° C water for 30 minutes, 1hour before bedtime. The patients in the combined group are asked to first bath their feet in water for 30 minutes and then Perform relaxation for 20 minutes in accordance with the above mentioned protocols.In the control group, nothing will be done in 3 consecutive nights of intervention,Interventions will take place for three consecutive days.All groups will receive regular care of the unit. The SMHSQ and Beck's questionnaire will be completed for three days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Diagnosis of acute coronary syndrome that 24-48 hours passed from the time they began to be hospitalized 2-ack of acute or chronic psychiatric or anxiety disorders 3-At least reading and writing skills4-Age 65-32 years old5-Complete alert6-A score of 25-16 (moderate anxiety) was obtained based on Beck's questionnaire
Exclusion criteria:1-Failure to motivate the patient to continue cooperation
2-Exacerbation of the disease for a period of intervention
3-Death of the patient
Intervention groups
Four groups of Benson's muscle relaxation,Foot bath,Combination group and control
Main outcome variables
Quality of Sleep- Anxiety
General information
Reason for update
Acronym
ACS
IRCT registration information
IRCT registration number:IRCT20190126042497N1
Registration date:2019-02-05, 1397/11/16
Registration timing:prospective
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Hoda Arianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 1449
Email address
hoda.aryanpour@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-07, 1397/11/18
Expected recruitment end date
2019-04-07, 1398/01/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety in patients with Acute Coronary Syndrom
Public title
combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Acute Coronary Syndrome
lack of anxiety or chronic psychatric disorder
First time admission in CCU ward
Passed at least one night from the patient's hospitalization
having written knowingly informed consent
Interest in program participation
lack of acute or chronic illness
At least reading and writing skills
Age 65-32 years old
Having healthy health (hearing and legs)
Complete alert
lack of membership in medical treatment services
A score of 25-16 (moderate anxiety) was obtained based on Beck's questionnaire
Sleeping and relaxing medications are the same
Lack of mental and motor disorders
Not having eczema or any type of ulcer in your legs
Not having diabetic ulcer or diabetic neuropathy diagnosis
lack of corporate programs of relaxation; Foot bath and similar techniques
Exclusion criteria:
Failure to motivate the patient to continue cooperation
Exacerbation of the disease for a period of intervention
Death of the patient
Age
From 32 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with acute coronary syndrome are selected by non probabilistic sampling, but randomly assigned to four intervention groups. In this method, all four states of the group are written on 16 cards and each will be placed in a sealed envelope. These packs are placed in a box, and the researcher does not know which groups of items are to be examined before choosing any of the envelopes. Prior to exposing the units, the researcher assisted in removing one of the envelopes from the box, in which of the 4 illnesses that entered the study would be included.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.YUMS.REC.1397.133
Health conditions studied
1
Description of health condition studied
Sleep
ICD-10 code
F51.2
ICD-10 code description
Nonorganic disorder of the sleep-wake schedule
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Measurement of Sleep Quality before the onset of intervention and on the morning of the third, fourth and fifth day of admission after the start of Benson's relaxation & Foot bath
Method of measurement
St Mary’s Hospital Sleep Questionnaire (SMHSQ)
2
Description
anxiety
Timepoint
Measurement of Anxiety before the onset of intervention and on the morning of the third, fourth and fifth day of admission after the start of Benson's relaxation & Foot bath
Method of measurement
Beck Anxiety Inventory (BAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed every night befor bedtime for three consecutive days by patients and supervised by the researcher.
Category
Behavior
2
Description
Intervention group: the warm Foot baths will perform for three consecutive nights for patients with 40 ° C water for 30 minutes, 1hour before bedtime. Legs up to 10 cm above the ankle will dip in a special plastic container. SMHSQ questionnaire and Beck Anxiety Inventory (BAI) questionnaire will be completed every day during the 7 to 8 am.
Category
Other
3
Description
Intervention group: Combination: The patients in the combined group are asked to first bath their feet in water for 30 minutes and then Perform relaxation for 20 minutes in accordance with the above mentioned protocols.
Category
Behavior
4
Description
Control group: In the control group, nothing will be done in 3 consecutive nights of intervention, but The SMHSQ questionnaire will be completed for three days and each day during 7 to 8 am.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee hospital
Full name of responsible person
Hoda Arianpour
Street address
Shahid Rajaee hospital, Parastar Ave., Beladian St.,Gachsaran Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 2222 4811
Email
hoda.aryanpour@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr.Ali MousaviZadeh
Street address
Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7230
Email
hoda.aryanpour@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Hoda Arianpour
Position
MS of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences
City
Gchsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 2222 4811
Email
hoda.aryanpour@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Marzieh Hosseini
Position
MS of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3333 7230
Email
m.hosseini235@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hoda Arianpour
Position
MS of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences
City
Gchsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 2222 4811
Email
hoda.aryanpour@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
General data such as demographic variables and outcomes under study will be published.
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
All researchers working in academic and scientific institutions who want the results of the study will be allowed to receive the data
Under which criteria data/document could be used
Data can be used to enhance science and use results in research
From where data/document is obtainable
School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran 00982143651000 nsahraea@gmail.com
What processes are involved for a request to access data/document
Once requested, the data will be delivered electronically or in person within one week.