Comparing the effects of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass graft
Comparing the effect of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass surgery
Design
A clinical trial on 126 patients candidates for CABG surgery with a control group, double blind and randomized in a block of 6
Settings and conduct
This study is conducted on patients who are candidates for CABG surgery in Imam Hossein (AS) Shahrood Hospital. Massage techniques or TENS will be performed on the second to fourth days after CABG. Then the quality of sleep, fatigue and anxiety of the patients will be evaluated on the morning of the fifth day by an evaluation that is blind to the type of interventions and groupings.
Participants/Inclusion and exclusion criteria
Inclusion:
Patients undergoing CABG surgery
No previous use of alcohol, sedative and anti-anxiety drugs or narcotics
Not using complementary medicine methods during the previous three months
Absence of wounds, phlebitis, trauma and arthritis in the massage area
exclusion:
Previous diagnosis of sleep disorders
Loss of consciousness and need for mechanical ventilation more than 24 hours after surgery
Contraindications to TENS use such as pregnancy, epilepsy and skin disorders in the area where the electrodes are used
Patients with severe communication disorder and unstable vital signs
Intervention groups
In the massage group, after the operation, classical massage will be performed for 30 minutes for each patient.
In the TENS group, after the operation, TENS with a frequency of 60 Hz, an electric current of 4 to 7 mA and a pulse duration of 0.25 milliseconds will be performed for 30 minutes for each patient.
In the control group, patients will only receive the standard care of the department.
Main outcome variables
sleep quality
fatigue
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200206046395N4
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Mobin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
mobinmottahedi1372@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-12, 1403/04/22
Expected recruitment end date
2025-07-13, 1404/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass graft
Public title
Comparing the effects of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing CABG surgery
No previous use of alcohol, sedative and anti-anxiety drugs or narcotics
Not using complementary medicine methods during the previous three months
Absence of wounds, phlebitis, trauma and arthritis in the massage area
Exclusion criteria:
Previous diagnosis of sleep disorders
Loss of consciousness and need for mechanical ventilation more than 24 hours after surgery
Contraindications to TENS use such as pregnancy, epilepsy and skin disorders in the area where the electrodes are used
Patients with severe communication disorder and unstable vital signs
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In the beginning, all the modes in which 3 letters A, B and C can be put together in a block of 6 are produced and a block is selected randomly and by placing among the blocks.The layout pattern in that block is used to allocate patients
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the study, it is not possible to blind the study participants. However, measures were taken in collecting information. After the intervention, the person collecting the information will not know the type of the participants' group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.SHMU.REC.1403.043
Health conditions studied
1
Description of health condition studied
Chronic ischaemic heart disease, unspecified
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
First, on the second day after the operation (before the intervention), the sleep quality of the patients will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, the quality of sleep will be evaluated again
Method of measurement
Richards–Campbell Sleep Questionnaire (RCSQ)
Secondary outcomes
1
Description
Anxiety
Timepoint
First, on the second day after the operation (before the intervention), the patients' anxiety will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, anxiety will be evaluated again
Method of measurement
The State-Trait Anxiety Inventory (STAI)
2
Description
Fatigue
Timepoint
First, on the second day after the operation (before the intervention), the fatigue of the patients will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, fatigue will be assessed again
Method of measurement
The multidimensional fatigue inventory (MFI-20)
Intervention groups
1
Description
intervention group: In the massage group, the classic massage procedure will be applied to the patient's hands without using any special equipment and will include the combination of 3 therapeutic massage methods: kneading, friction and petrissage. Massage will be done on both hands for 30 minutes, i.e. 15 minutes on each hand.
Category
Treatment - Other
2
Description
Intervention group: In the TENS group, the electrodes will be placed in the PC7 and LI4 regions. TENS with a frequency of 60 Hz, an electric current of 4 to 7 milliamp and a pulse duration of 0.25 milliseconds will be used for 30 minutes, so that the stimulation effect does not cause discomfort and muscle contraction in the patient.
Category
Treatment - Other
3
Description
Control group: In the control group, standard and routine care will be performed in the inpatient department after CABG surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Shahroud Hospital
Full name of responsible person
Mobin Mottahedi
Street address
Imam Hossein (AS) Shahrood Hospital, Imam St., at the end of 28 meters of Ayat A... Tawhidi, Shahrood
City
Shahroud
Province
Semnan
Postal code
۳۶۱۶۹۵۱۸۳۵
Phone
+98 23 3234 2000
Email
Mobinmottahedi1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Bagheri
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahrood
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@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