Determining of the effect of head and facial massage on sleep condition after
Coronary artery bypass graft surgery
Design
72 patients were randomly assigned into two groups of 36 in a randomized massage and control group based on the Permuted Block Randomization computer program.
Settings and conduct
The intervention starts from the third night after the operation and is performed 3 consecutive nights around 19-21 pm head and face massage for the intervention group .
In the evening of the third to fifth day after the operation, before the intervention the RCSQ questionnaire for both massage therapy and control groups is completed. The study site is Fatemeh Zahra Hospital in Sari.
Participants/Inclusion and exclusion criteria
The age of adults over 18 years of age, those undergoing coronary artery bypass grafting, their vital signs are stabilized, not needing for intra-aortic pump balloons and intubation for more than 24 hours, no infection or sores on the head and face; Pulmonary drainage and discharge of more than 200 cc per hour, The patient's unwillingness to cooperate during the research, The patient's condition becomes critical and the patient returns to the operating room.
Intervention groups
The intervention begins on the third night after the operation and 3 consecutive nights 2 to 3 hours before bedtime, for the intervention group 15 minutes head and face massage is done and in the control group, no intervention is done.
Main outcome variables
sleep condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N35
Registration date:2021-01-22, 1399/11/03
Registration timing:registered_while_recruiting
Last update:2021-01-22, 1399/11/03
Update count:0
Registration date
2021-01-22, 1399/11/03
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
2021-01-20, 1399/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of head and facial massage on sleep condition after Coronary artery bypass graft surgery
Public title
The effect of head and facial massage on sleep condition after Coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/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, vision or speech impairment)
not using drug
lack of cognitive problems and delirium
not using anti-depressant drugs and antihistamines
lack of sleep disorders treated in a recent month
lack of severe neuropathy in the patient
not needing for intra-aortic pump balloons and intubation for more than 24 hours
no infection or sores on the head and face
Exclusion criteria:
Pulmonary drainage and discharge of more than 200 cc per hour
The patient's unwillingness to cooperate during the research
The patient's condition becomes critical and the patient returns to the operating room
The patient's unwillingness to continue working and taking sleeping drugs and antihistamines
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are divided into two groups of 36 interventions and witnessed by random numbers provided with computer software and Permuted Block Randomization under the guidance of a statistical consultant.18 blocks of 4 so that in each block there are 2 people from each group. 72 envelopes have been designed in which the letters A (massage therapy group) and B (control group) are embedded according to a computer program, and the envelopes from number one to 72 are prepared on the envelopes. He enters and has the criteria for admission, After obtaining written consent, he enters the study and the sampling continues until patient number 72.
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
2020-12-28, 1399/10/08
Ethics committee reference number
IR.MAZUMS.REC.1399.803
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 to fifth day after surgery, before the intervention in control and massage group.
Method of measurement
Richard Campbell Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: head and facial massage will be done for 15 minutes for every person from third day after surgery started and continued for 3 nights.
Category
Lifestyle
2
Description
Control group: Not done any massage
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital in Sari
Full name of responsible person
Masoomeh Rajabi Ozudi
Street address
Juibar three ways, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
masoomehrajabi971@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
48157-33971
Phone
+98 11 3397 8055
Email
masoomehrajabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
phd Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Reseach Assistant of Mazandaran University of Medical sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
masoomehrajabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Baghri Nesami
Position
phd Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sari, Jouibar junction, Mazandaran University of medical science
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
phd Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sari, Jouibar junction, Mazandaran University of medical science
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
Anna3043@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