Comparison of the effect of hand (P6 Point) and foot (SP6 Point) reflexology with control group on the anxiety level of patients undergoing coronary angiography at Shahid Dr. Beheshti Hospital in Kashan in 2024
A controlled, parallel-group, single-blind, randomized, clinical trial of 90 patients. Research Randomizer software was used for randomization.
Settings and conduct
Patients who have hospitalized in the angiography department and declare their informed desire to participate in the study will be randomly assigned to three groups based on the randomization software.
These groups have no connection with each other & at the time of study, each patient received one of three interventions in addition to routine treatment and had no relationship with other people, and the output information is measured by an experienced nurse with the level of M.Sc. of critical care nursing who has achieved the necessary potential.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willing to participate in the study; performing coronary angiography for the first time; hemodynamic stability before angiography; does not have a history of heart surgery or heart attack; do not have a current drug addiction; Not taking sedative or anti-anxiety drugs (24 hours before angiography); do not have a history of epilepsy and known disorders of the thyroid gland; Do not have local problems in the place of reflexology; Do not have a history of relaxation and psychotherapy courses. do not have employment in medical and therapeutic occupations. Have an anxiety score of 43 or higher.
Exclusion criteria: the patient's unwillingness to continue participating in the research; The need for C.P.R. of the patient; cancellation of angiography and interruption of the patient's angiography intervention; complications such as chest pain and shortness of breath following angiography, which lead to the prescription of sedatives.
Intervention groups
P6 hand reflexology massage; SP6 foot reflexology massage; General hand massage in the control group
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060855N1
Registration date:2024-03-09, 1402/12/19
Registration timing:prospective
Last update:2024-03-09, 1402/12/19
Update count:0
Registration date
2024-03-09, 1402/12/19
Registrant information
Name
Majid Najafloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3740 3783
Email address
najafloo-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-13, 1402/12/23
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hand (P6 Point) and foot (SP6 Point) reflexology with control group on the anxiety level of patients undergoing coronary angiography at Shahid Dr. Beheshti Hospital in Kashan in 2024
Public title
Comparison of the effect of hand (P6 Point) and foot (SP6 Point) reflexology with control group on the anxiety level of patients undergoing coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who, according to the diagnosis of a cardiologist, have an indication for an angiography procedure and have referred to the angiography department of Shahid Dr. Beheshti Kashan Hospital.
Exclusion criteria:
Patients who undergo an angiography procedure for the second time or more.
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria and agree to participate in the study will be randomly assigned in three groups: Hand interventions (point P6), foot interventions (point SP6) and control group. Research Randomizer software is used for random assignment. In this study, random allocation will be based on simple and individual randomization. This software is based on the number of samples and defined groups studied by the researcher and whether the samples are repetitive or not, by providing a series of information and numbers, will offer a list with the number of groups requested and with random numbers, for random allocation of samples.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients willing to participate in the study, after obtaining informed consent and evaluating the entry criteria, are divided into three groups, who, despite having informed consent, are blind to whether they are in the hand intervention group or the foot intervention group or the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Blvd - Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2024-02-18, 1402/11/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.271
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Anxiety score in the SpielBerger Anxiety Questionnaire
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
SpielBerger Anxiety Questionnaire
Secondary outcomes
1
Description
Systolic Blood pressure
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
In mmHg
2
Description
Diastolic Blood pressure
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
In mmHg
3
Description
Mean Arterial Pressure
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
In mmHg
4
Description
Pulse count
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
Count per Minute
5
Description
Respiratory rate
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
Number per Minute
6
Description
Arterial hemoglobin saturation percentage
Timepoint
10 minutes before, immediately after, 30 minutes after the intervention
Method of measurement
Saturation percentage by pulse oximetry
Intervention groups
1
Description
Intervention group: hand reflexology; The patient is placed in a quiet room for the procedure. In the hand reflexology intervention group, the patient is placed in a supine position, with the head of the bed at an angle of 30 degrees from the horizon, and the therapist performs reflexology after washing his hands with warm water and after drying his hands. It will start with the first finger of the right hand. The reflexology point related to anxiety on the level of the hand, point P6 (Nei-Kuan), three fingers (second to fourth hand) joined together, below the fold of the wrist and located in the channel between the two tendons of Flexor carpi radialis and Palmaris longus has it. Reflexology of the P6 point is performed by applying pressure on this point for 5 minutes, at a depth of 0.5 to 1 inch (1.26 to 2.52 cm) depending on the size of the patient's hand. The amount of pressure applied to the hand reflexology areas will be such that the patients, while feeling the pressure from the first finger of the therapist's right hand, will not feel any pain in these points.
Category
Treatment - Other
2
Description
Intervention group: foot reflexology; In the foot reflexology intervention group, the patient is placed in a supine position, with the head of the bed at a 30 degree angle from the horizon, and the therapist performs reflexology after washing his hands with warm water and after drying his hands. It starts with the first finger of the right hand. The reflexology point related to anxiety on the level of the foot, point SP6 (Sun-Yin-Jiao), four fingers (second to fifth hand) joined together, above the medial malleolus, is located on the posterior line of the tibia. SP6 point reflexology is done by applying pressure on this point for 5 minutes, at a depth of 0.5 to 1 inch (1.26 to 2.52 cm) depending on the size of the patient's foot. The amount of pressure applied to the foot reflexology areas will be such that the patients, while feeling the pressure from the first finger of the therapist's right hand, will not feel any pain in these points.
Category
Treatment - Other
3
Description
Control group: In addition to the usual nursing care of angiography candidates, patients will be subjected to a simple hand massage for 10 times.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of Kashan university of medical sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
taghadosi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. GholamAli Hamidi
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Fax
+98 31 5558 9338
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
Taghadosi_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghadosi
Position
Associate Professor, Chief editor of Feyz Journal Department
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qutb Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Email
Taghadosi_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Majid Najafloo
Position
Critical cares M.Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9392
Fax
Email
najafloo-m@kaums.ac.ir
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
At this stage, the goal is to approve the study protocol, and after the completion of the work, the target journal and its results will be adjusted according to the journal protocol (Author's guide) and a decision will be made for publication.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available