Protocol summary
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Study aim
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Comparing the effect of hand and foot reflexology on the anxiety and pain of patients hospitalized in CCU to increase the quality of life of patients hospitalized in CCU.
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, on 108 patients, 6-block random assignment method was used for randomization.
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Settings and conduct
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Hazrat Zahra Hospital, Khomein city, with randomized clinical trial method
Pain will be measured with the VAS scale and anxiety with the Spielberger questionnaire.
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Participants/Inclusion and exclusion criteria
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• Willingness to participate in the study
• Age over 18 years old
• Not being pregnant
• Having heart disease
•
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Intervention groups
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After assigning the patients to three hand, foot & control groups, each of them will receive their own intervention (hand or foot reflexology) and their results will be compared with each other.
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Main outcome variables
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pain-anxiety
General information
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Reason for update
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update study protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240609062052N1
Registration date:
2024-06-22, 1403/04/02
Registration timing:
prospective
Last update:
2024-10-02, 1403/07/11
Update count:
1
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Registration date
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2024-06-22, 1403/04/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-27, 1403/04/07
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Expected recruitment end date
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2024-07-29, 1403/05/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of foot and hand reflexology on pain severity and anxiety in cardiac care unit patients in Hazrat Zahra hospital in Khomein city.
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Public title
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Comparing the effect of foot and hand reflexology on pain severity and anxiety in cardiac care unit patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
be a cardiac patient
orientation to place & time & persons
age be over 18 years old
Exclusion criteria:
be pregnanted
be a malignant patient
have any fracture at feet or hands
be a hand or foot amputated person
be sensitive to hand or foot massage
be an unstable angina case
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients with an equal number of members are randomly assigned to each of the intervention and control groups. The block randomization method with 6 blocks will be used for this purpose. Thus, by using the Sealed Envelope site to generate random numbers in a block method, the randomization sequence will be produced according to the required sample size for Three groups (foot, hand and control method). In the beginning, all the modes where 2 letters A and B can be put together in a block of 6 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. In order to avoid selection bias, the random allocation of people to the study groups will be hidden and this sequence will remain hidden until the interventions. For this purpose, dark envelopes with consecutive numbers are used to enclose the sequences.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To prevent any bias, patient assignments were placed in sealed envelopes, prepared by a third party with no involvement from the research team. The data-collecting researcher was blinded to the patient's group allocation in this study. Data analysis was conducted by an independent statistician who was also unaware of the group assignments. Due to the application of reflexology on different parts of the body, blinding of patients was not possible.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-05-28, 1403/03/08
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Ethics committee reference number
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IR.KHOMEIN.REC.1403.009
Health conditions studied
1
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Description of health condition studied
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Acute myocardial infarction
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ICD-10 code
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I21
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ICD-10 code description
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ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
2
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Description of health condition studied
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Angina pectoris
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ICD-10 code
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I20
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ICD-10 code description
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Angina pectoris
3
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Description of health condition studied
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Other acute ischemic heart diseases
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ICD-10 code
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I24
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ICD-10 code description
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Other acute ischemic heart diseases
4
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Description of health condition studied
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Chronic ischemic heart disease
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ICD-10 code
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I25
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ICD-10 code description
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Chronic ischemic heart disease
5
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Description of health condition studied
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Atherosclerosis
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ICD-10 code
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I70
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ICD-10 code description
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Atherosclerosis
6
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Description of health condition studied
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Hypertensive heart disease
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ICD-10 code
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I11
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ICD-10 code description
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Hypertensive heart disease
7
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Description of health condition studied
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Essential (primary) hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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Anxiety score in Spielberger questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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Anxiety:Spielberger questionnaire
2
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Description
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pain score according to VAS criteria
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Timepoint
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Before and after the intervention
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Method of measurement
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Pain: Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group: hand reflexology group In this intervention, 36 patients hospitalized in the CCU department, who were assigned to the hand group by a simple random method, first completed the demographic information questionnaire, Spielberger and the visual pain scale (VAS). Then the patients, twice In a day (for 30 minutes each time) and for 3 days in a row, they are subjected to hand massage therapy. Reflexology is performed using a lubricating fluid (natural sunflower oil) to reduce friction on the hand. At first, general massage for 5 minutes on the right hand and back, reflexology is performed by performing special movements of both hands for 10 minutes.; Then the Spielberger questionnaire and the VAS criterion will be completed again.
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Category
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Other
2
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Description
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Intervention group: foot reflexology group In this intervention, 36 patients hospitalized in the CCU department, who were assigned to the foot group by a simple random method, first completed the demographic information questionnaire, Spielberger and visual pain scale (VAS). Then the patients undergo massage therapy twice a day (for 30 minutes each time) for 3 consecutive days. Reflexology is performed using a lubricating fluid (natural sunflower oil) to reduce friction on the feet. At first, general massage for 5 minutes on the right leg and back, reflexology is performed by performing special movements of two hands in the area related to the heart for 10 minutes. Then the Spielberger questionnaire and the VAS criterion will be completed again. At the end of this intervention, the results of two interventions will be compared with one another.
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Category
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Other
3
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Description
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Control group: Control group: The control group in this intervention is 36 inpatients in the CCU who are assigned to the control group by simple randomization method, first complete the demographic information questionnaire, Spielberger and visual pain scale (VAS). Then the patients will not undergo any intervention and will complete the Spielberger test and VAS again as in the previous two nodes. Finally, the results of these 3 groups will be compared with each other.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Khomein Faculty of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All information and data will be shared after de-identifying people.
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When the data will become available and for how long
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Access will start 1 month after the results are published.
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To whom data/document is available
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All people related to medical and health matters
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Under which criteria data/document could be used
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The use of data will only be subject to mention of the source of the study and the authors.
It is definitely necessary to obtain permission from the authors and researchers of the study.
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From where data/document is obtainable
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with this emali: zeidypouya@gmail.com
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What processes are involved for a request to access data/document
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After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester.
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Comments
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