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The effect of foot reflexology massage on the rate of well-being and death anxiety in patient undergoing CABG

Protocol summary

Study aim
The effect of foot reflexology massage on the level of well-being and death anxiety in patients undergoing coronary artery bypass graft surgery
Design
66 patients were randomly assigned into two groups of 33 in a randomized massage and control group based on the Permuted Block Randomization computer program.
Settings and conduct
Foot reflex massage will be performed for 15 minutes from the second to the fourth day for 15 consecutive days.Massage is not performed for the control group, and the death anxiety questionnaire and the instrument of feeling well on the day before the operation and the fourth day after the operation are always filled with the intervention group. The study site is Fatemeh Zahra Hospital in Sari.
Participants/Inclusion and exclusion criteria
People over 18 years old, those undergoing coronary artery bypass surgery only, no pulmonary drainage and discharge more than 200 cc / h, their vital signs stabilized, no drainage Left ventricle less than 35%, no communication problems, no drug and alcohol use, no psychiatric treatment, no anxiety, depression and antihistamine 4 hours before Intervention, absence of severe neuropathy in the patient, absence of infection or ulceration of the feet, absence of extremity amputation،No history of arthritis or joint rheumatism, no valve replacement or repair, no need for intra-aortic pump balloons and no intubation for more than 24 hours,No previous experience of massage or acupuncture during the past 3 weeks, score above 45 on the Templar Death Anxiety Questionnaire
Intervention groups
For the intervention group, the reflective foot massage includes the general massage technique, which lasts about 5 minutes, and the specialized massage of the toe joints, which lasts 10 minutes. For the control group, the massage is not performed.
Main outcome variables
Death anxiety and feeling good

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N32
Registration date: 2020-08-10, 1399/05/20
Registration timing: prospective

Last update: 2020-08-10, 1399/05/20
Update count: 0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-08, 1399/06/18
Expected recruitment end date
2021-01-08, 1399/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on the rate of well-being and death anxiety in patient undergoing CABG
Public title
The effect of foot reflexology massage on the rate of well-being and death anxiety in patient undergoing CABG
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above Candidates for coronary artery bypass graft surgery Lack of pulmonary drainage and discharge more than 200 cc per hour Their vital signs are stable (blood pressure, temperature, pulse, respiration) No left ventricular ejection fraction less than 35% No communication problems (hearing, vision or speech disorders) Non-use of drugs and alcohol Lack of treatment for mental illness Do not take antihistamines, antidepressants or antihistamines 4 hours before the intervention Absence of severe neuropathy in the patient Absence of infection or sores on the soles of the feet No limb amputation No history of osteoarthritis or rheumatoid arthritis No valve replacement or repair No need for intra-aortic pump balloons and no intubation for more than 24 hours Lack of previous experience in massage or acupuncture during the last 3 weeks Get a score of 45 or higher from the Templer Death Anxiety Questionnaire, which indicates the presence of death anxiety
Exclusion criteria:
The patient's unwillingness to cooperate during the research The critical condition of the patient and the patient's return to the operating room The need to take antidepressants, antidepressants, and antihistamines while studying Death of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are divided into two groups of 33 interventions and witnessed by random numbers provided with computer software and Permuted Block Randomization under the guidance of a statistical consultant. 66 envelopes have been designed in which the letters A (reflexology group) and B (control group) are embedded according to a computer program, and the envelopes from number one to 66 are prepared on the envelopes. He enters and has the criteria for admission. After obtaining written written consent, he enters the study and the sampling continues until patient number 66.
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandran University of Medical Sciences,Vice chancellor for research,Moalem street,Moalem square,Sari,Mazandaran,Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-03-08, 1398/12/18
Ethics committee reference number
IR.MAZUMS.REC.1398.1394

Health conditions studied

1

Description of health condition studied
Well_being and death anxiety in patient undergoing CABG
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Well_being
Timepoint
For the intervention and control group, on the day before the operation and on the fourth day after the operation
Method of measurement
Subjective Well-being

2

Description
Death anxiety
Timepoint
For the intervention and control group, on the day before the operation and on the fourth day after the operation
Method of measurement
Templer questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Foot reflexology massage will be done for 30 minutes(15 minutes per foot) from the evening of the second day after the operation for 3 consecutive days (the second to the fourth day after the operation) using Firooz baby oil, made by Firooz company with number ( ISO 9001 ISO 14001 OHSAS 18001) will be performed for each person.
Category
Lifestyle

2

Description
Control group: Do not get any massage
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital in Sari
Full name of responsible person
Atieh Kalbadi Nejad
Street address
Juibar tree way,Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1985
Email
atieh1369.kolbadinejad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Majid Saeedi
Street address
Mazandaran University of Medical Sciences ,valiye asr highway, Joybar 3way ,Imam Sq,Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
atieh1369.kolbadinejad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
atieh1369.kolbadinejad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Bagheri Nesami
Position
Nursing ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mzandaran University of Medical Sciences,three way Joibar,highway basij,imam square,Sari,Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoume Bagheri Nesami
Position
Nursing ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 1985
Email
atieh1369.kolbadinejad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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