Comparison of the effect of foot reflexology massage with acupressure on patients' sleep after coronary artery bypass graft
Design
Patients are divided into 3 groups of 20 Acupressure and Reflexology and Control Using random numbers provided with computer software and Permuted Block Randomization By the Statistics Advisor, they will be randomly assigned. 10 blocks that has 6 member. In each block, there are 2 people from each group.
Settings and conduct
The intervention begins on the third night after the operation and 4 consecutive nights around 19-21 o'clock 2 to 3 hours before bedtime for the intervention group do Foot massage and acupressure. On the third to seventh day after the operation, the sleep quality questionnaire is completed again. The location of the study is Imam Reza Hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age of adults over 18 years of age, those undergoing coronary artery bypass grafting, their vital signs are stabilized (blood pressure, temperature, pulse, respiration), lack of communication problems Hearing impairment, vision or speech, not using anti-depressant drugs and antihistamines,
Exclusion criteria: infection or ulcer in the palms of the feet, hands and forehead, amputation of the extremities, replacement or repair of the valve.
Intervention groups
The intervention begins on the third night after the operation and 4 consecutive nights 2 to 3 hours before bedtime.In reflexology group 5 minutes general massage and 10 minutes of specialized massage is done for each foot. in acupressure 7 points are stimulated that for every point 5 seconds pressure and 1 second rest until It reaches 3 minutes. The whole intervention takes 21 minutes. In control group, only applying ointment to feet is done.
Main outcome variables
sleep condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N29
Registration date:2019-06-06, 1398/03/16
Registration timing:registered_while_recruiting
Last update:2019-06-06, 1398/03/16
Update count:0
Registration date
2019-06-06, 1398/03/16
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
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupressure and reflexology on sleep condition in the patient after coronary artery bypass graft surgery
Public title
the effect of acupressure and reflexology on sleep condition in the patient has heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age of adults over 18 years of age
Do coronary artery bypass graft surgery
Exclusion criteria:
Drug use
Having communication problems (hearing impairment, vision or speech)
Having severe neuropathy in the patient
Having valve replacement or repair
Having infection or ulcer on the soles of the feet, hands and forehead
Having history of acute arthritis or rheumatoid arthritis
End extremities amputation
Using antidepressants and antihistamines
Their vital signs have not been stabilized (blood pressure, temperature, pulse, respiration)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for 3 groups of 20 people of acupressure and reflexology and control Using random numbers provided with computer software and Permuted Block Randomization By the Statistics Advisor, they will be randomly assigned.10 blocks that has 6 member. In each block, there are 2 people from each group.
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
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MAZUMS.REC.1398.050
Health conditions studied
1
Description of health condition studied
sleep condition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sleep condition
Timepoint
determination sleep condition at third day after surgery and at fourth until seventh day after surgery in control and massage group
Intervention group: Foot reflexology massage will be done for 30 minutes (15 minutes each foot)5 minutes general massage and 10 minutes special massage. for every person from third day after surgery started and continued for 4 nights.
Category
Lifestyle
2
Description
Intervention group: acupressure performed on 7 point of body like forehead, radial, ulnar, solar plexus with 3 to 5 kg pressure for 5 seconds pressure and 1 seconds relax until it reaches 3 minutes. it takes 21 minutes for 4 Consecutive nights.
Category
Lifestyle
3
Description
Control group: Not done any massage or acupressure
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital of Holy Mashhad
Full name of responsible person
Seyed Milad Hoseini Matankolaee
Street address
Juibar three ways, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
Smhnursing@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
University researches Assistance
Street address
Deputy of Research of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1986
Email
Smhnursing@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
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
48157-33971
Phone
+98 11 3379 5508
Email
Smhnursing@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran 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
Masoumeh 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
Smhnursing@yahoo.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