Protocol summary
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Study aim
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The effect of ear acupressure (Auriculotherapy) on cognitive failure in nurses, Kashan, 2022
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Design
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Clinical trial type study with control group with parallel groups, single blind, randomized, on 56 patients, for block randomization of Sealed Envelope Ltd. software. 2017 available through www.sealedenvelope.com, a total of 9 blocks, 4 blocks of 4 and 5 blocks of 8, defined.
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Settings and conduct
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A randomized clinical trial with a control group and a blind strain (participants) on qualified nurses in Shahid Beheshti Hospital in Kashan.
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Participants/Inclusion and exclusion criteria
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Entry criteria include: moderate to high cognitive impairment (getting a score of 40 or higher on the Occupational Cognitive Status Questionnaire), working in inpatient wards (direct patient care), having a work experience of at least 2 years in the hospital, the criteria for not entering include: suffering from a chronic physical illness or known psychological disorders according to the individual's own statement, hospitalization, suffering from a serious and acute physical or mental illness during the study, taking treatment, acute and severe stress (death of loved ones, divorce,...) During the study, consumption of cigarettes, drugs and alcohol according to the individual, use of acupressure or acupuncture during the last three months.
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Intervention groups
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In the auriculotherapy intervention group, using ZHONG YANG brand vaccaria seeds, made in China, on the Shan Man point, zero point, hippocampus, main brain point, brain and memory 1 and 2, which are related to cognitive function, for six weeks, five days a week, every Press each point three times a day and each time for one minute. In the control group, adhesives will be applied at the desired points but without grains and no pressure will be applied on them.
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Main outcome variables
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Cognitive failure score
General information
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Reason for update
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Changing the date of the ethics committee and the start of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100211003329N10
Registration date:
2022-11-04, 1401/08/13
Registration timing:
registered_while_recruiting
Last update:
2022-11-16, 1401/08/25
Update count:
1
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Registration date
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2022-11-04, 1401/08/13
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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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2022-11-02, 1401/08/11
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Expected recruitment end date
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2023-03-02, 1401/12/11
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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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The effect of ear acupressure (Auriculotherapy) on cognitive failure in nurses
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Public title
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The effect of ear acupressure (Auriculotherapy) on cognitive failure in nurses
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Working in inpatient departments (direct patient care)
Having a work experience of at least 2 years at the bedside
Consent to participate in the study
Having a university degree in nursing
Moderate to high cognitive failure (getting a score of 40 or higher on the Occupational Cognitive Status Questionnaire)
The health of an organ in the area of the earlobe
Exclusion criteria:
Lack of access to samples during the study (emigration, death, etc.)
Hospitalization
Acute and severe stress (death of loved ones, divorce,...) during the study
Allergy to glue (sensitivity, redness, etc.) or any intolerance
Non-observance of the intended criterion in relation to the daily average duration of pressure to all points in each week of the intervention
Simultaneous use of other non-pharmacological methods
Treatment
Serious and acute physical or mental illness during the study
using acupressure or acupuncture during the last three months
using cigarettes, drugs and alcohol according to the person's own statement
pregnancy
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Age
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From 25 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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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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the eligible samples will be placed in the list in the order of review and then will be allocated to each of the two intervention and control groups by block randomization in the form of blocks of 4 and 8. Using Sealed Envelope Ltd software. 2017 available through the website www.sealedenvelope.com 4 blocks of 4 and 5 blocks of 8, a total of 9 blocks were defined, which will be assigned to groups based on the order specified by the mentioned tool.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The participants are unaware of the nature of the seeds attached to their ears.
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Placebo
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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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2022-10-23, 1401/08/01
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1401.140
Health conditions studied
1
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Description of health condition studied
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Cognitive failure
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ICD-10 code
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G31.84
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ICD-10 code description
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Mild cognitive impairment, so stated
Primary outcomes
1
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Description
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Cognitive failure score
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Timepoint
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Before the intervention, 6 weeks after the start of the intervention and 4 weeks after the end of the intervention
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Method of measurement
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The 30-question form of occupational cognitive failure questionnaire (OCFQ)
Secondary outcomes
1
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Description
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Allergy to seed
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Timepoint
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weekly
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Method of measurement
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Diary sheet
Intervention groups
1
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Description
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Intervention group: In the intervention group, researcher seed vaccaria Mark ZHONG YANG, made in China, will stick the 7 points related to cognitive function, including: Shen Men, zero point, hippocampus, main brain point, brain and memory 1 and 2 and to the unit The research (nurse) will be taught to press the points using the thumb and forefinger for six weeks, five days a week and three times a day, and each time each point for one minute. It should be noted that during the 6 weeks of the intervention, Vaccaria seeds will be stuck by the researcher alternately on both ears every week, after cleaning the skin with alcohol cotton. seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place. During the intervention, a daily note sheet will be provided to the nurse every week, in which the number of times of pressure and the duration of pressure to all points each time, the occurrence of allergic reactions and the start of new medication will be determined. During the intervention period, every week all the participants will be visited at the agreed place and new stickers will be attached to them, and a daily note sheet will be given to them and another sheet will be given to them for the next week. If in the intervention group, the average duration of pressure on all points during each week of the intervention is less than 14 minutes per day, that person will be excluded from the study. Sticking the seeds will continue for 6 weeks and the samples will be followed up 4 weeks after the end of the intervention. Occupational cognitive impairment questionnaire will be completed by the samples at the beginning of the study, after the end of the intervention and 4 weeks after the end of the intervention. At the time of sampling, the workplace address and phone number of the samples were recorded, and during the intervention period, at the end of each week, also in order to follow up 4 weeks after the end of the intervention, by phone regarding the time and place of the visit and if necessary Transportation will be coordinated with him.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group, adhesives will be applied to the points of shen men, zero point, hippocampus, main brain point, brain and memory 1 and 2, but without seeds and no pressure will be applied on them. It should be noted that during the 6 weeks of the intervention, in the control group, non-seeds adhesives will be applied alternately on both ears by the researcher every week after cleaning the skin with alcohol cotton. Seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place.
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Category
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Placebo
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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No
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Title of funding source
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Kashan University 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Not done yet
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available