The effect of foot reflexology on anxiety and physiological parameters in patient under coronary artery bypass graft surgery referred to Dr.Heshmat educational and remedial center in Rasht, 2020
Determining the effect of foot reflexology massage on anxiety and physiological parameters in patients under coronary artery graft surgery in Rasht, 2020.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 66 patients. For randomization, block randomization method and the 2019 online randomization service was used.
Settings and conduct
The present study was performed at Dr. Heshmat Hospital in Rasht on patients undergoing coronary artery bypass graft surgery. On the first day of the patient's transfer to the cardiac surgery department, after obtaining his consent, anxiety levels and physiological indicators were measured in all three groups of test, control and placebo. The study is two-course and the person allocating the samples in the groups and the analyst are not aware of the placement of the samples in the groups.
Participants/Inclusion and exclusion criteria
Age: 20-80 years old; candidate for open heart surgery; full awareness; having a healthy lower limb
Intervention groups
Group A: foot reflexology massage of the important points of the sole of each foot for 15 minutes. Group B: Heel massage superficially without any pressure. Group C: No intervention on them
Main outcome variables
Anxiety level and physiological parameters (systolic, diastolic blood pressure, heart rate, respiration rate and arterial oxygen saturation percentage)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080825001083N10
Registration date:2020-05-29, 1399/03/09
Registration timing:prospective
Last update:2020-05-29, 1399/03/09
Update count:0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Majid Pourshaikhian
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 5768
Email address
m_pourshaikhan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety and physiological parameters in patient under coronary artery bypass graft surgery referred to Dr.Heshmat educational and remedial center in Rasht, 2020
Public title
The effect of foot reflexology on anxiety and physiological parameters in patient under coronary artery bypass graft
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction to participate in the study
Candidate of non-emergency open heart surgery
Full awareness
Having a healthy limb (especially the soles of the feet)
Exclusion criteria:
No history of open heart surgery
No history of mental health problems, such as depression, according to medical history reports
No heart pacemaker
No alcohol or drug abuse
No history of chronic pain
Lack of previous history of reflexology
Lack of visual and auditory disorders
Do not take analgesic or sedatives for 3 h. before the intervention
No history of mitral valve replacement or regurgitation
Absence of the disorder during open heart surgery or recovery or hospitalization that has also affected the patient's anxiety
Lack of a history of various psychological changes that have a significant impact on the results of anxiety levels in the patient.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible individuals will be divided into three groups of foot reflexology massage, routine massage, and control using block-randomized sized six-block blocking. In order to produce the randomization list, the 2019 online randomization service (the Sealed Envelope Ltd) was used: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the present study, the double-blind method was used. Thus, the analyst and the person allocating the samples (to three groups A, B and C) do not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Opposite to 17 Shahrivar Hospital, Sayadati St., Namjoo St. Tel: 33336394
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.GUMS.REC.1399.041
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft surgery
ICD-10 code
I25
ICD-10 code description
Ischemic Heart Disease
Primary outcomes
1
Description
Anxiety level in Spielberger's questionnaire
Timepoint
At the beginning of the study (before the intervention) and 10 minutes after the foot reflexology massage
Measurement of physiological parameters at the beginning of the study (before the intervention) and 10 minutes after the reflex floor massage
Method of measurement
Monitoring system of vital signs made in Iran and Sazegar Gostar Company, VISTA model
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (A): Foot Reflexology massage. Before the massage, the researcher first washes his hands with warm water and smears them with sweet almond oil. He then massages the entire sole of the foot with special attention to the important reflection points of the sole of the foot. This intervention is performed for each leg for 15 minutes. First the right leg and then the left leg, which takes a total of 30 minutes. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded.
Category
Treatment - Other
2
Description
Intervention group (B) or placebo group: Heel massage is performed superficially in patients without any pressure. 10 minutes after the intervention, the consequences of the intervention (anxiety level and physiological parameters) are recorded.
Category
N/A
3
Description
Control group (C): On the third day after coronary artery graft and after transfer to the surgical ward, the level of anxiety and physiological parameters are measured, without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Heshmat hospital
Full name of responsible person
Mehri Shahidi
Street address
Next to Guilan Management and Planning Organization, Dr. Heshmat Hospital, 15 Khordad St. Rasht