Protocol summary
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Study aim
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Determine The effect of acupressure on anxiety and pain of dressing in patient with burns.
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Design
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Clinical trials with control and placebo group, Blind two-sided, Randomized.
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Settings and conduct
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This study was a double blind randomized trial with a sample size of 60 people, according to previous studies and 95% confidence level and 80% strength. The research environment of patients referred to the burn clinic of Imam Reza Hospital in Mashhad.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: alert and oriented; age between 18-60 years old; ability to read and write; to try to collaborate on the research; no cognitive and psychological disorders based on medical records; grade 2 burns, either superficial or deep, or both, with an area of less than 10%; no audicating and visual problems; no burns at the place of application of pressure points; no history of addiction or consumption of opioid analgesics; no history of sensory disorder in the burned limb.
Exit criteria: the person's desire to continue cooperation at each stage of the study; patient's need for emergency medical intervention and the inability to use acupressure during intervention.
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Intervention groups
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For the intervention group, immediately before the dressing begins, an acupressure session is performed for 15 minutes by a nurse (researcher). First, the right (He gu) point then the same point in the left hand and at the end (Yin tang) each one for 5 minutes, is compressed continuously to the standard rate(3-4 kilograms). Patients in the placebo group also received no intervention، Only by placing the researcher next to them and just touching the acupressure points without pressure just before dressing.
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Main outcome variables
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Pain severity score; score of anxiety
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180902040926N1
Registration date:
2019-10-13, 1398/07/21
Registration timing:
prospective
Last update:
2019-12-22, 1398/10/01
Update count:
1
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Registration date
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2019-10-13, 1398/07/21
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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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2019-10-14, 1398/07/22
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Expected recruitment end date
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2019-11-06, 1398/08/15
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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 accupressure on anxiety and pain of dressing in patient with burns.
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Public title
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The effect of accupressure on anxiety and pain of dressing in patient with burns.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Burn with Degree 2 in Surface or Deep Less than 10%
Beware and Orient
No cognitive and psychological disorder
No drug addiction or drug use
Non-burning pressure points at the acupressure location
No history of sensory disorder in the limb with burns
Exclusion criteria:
Unwillingness to continue research
Emergency status (Such as respiratory distress, water and electrolyte disturbances) or pain intolerance and the need for emergency medical intervention to control pain
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Age
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From 18 years old to 60 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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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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By simple randomization and classification method with the help of random number table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The samples were divided into two intervention and placebo groups have no information about which group they are in.
Researcher colleagues are unaware of the information gathered and the results of the study.
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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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2019-07-21, 1398/04/30
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1398.037
Health conditions studied
1
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Description of health condition studied
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Pain
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Anxiety
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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Burn
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain score in the questionnaire VAS
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Timepoint
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Measure the severity of pain immediately before the intervention and during and after changing the dressing.
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Method of measurement
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Visual Analog Scale for pain Severity measurement (VAS)
2
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Description
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Anxiety Score in the questionnaire BSPAS.
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Timepoint
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Measure the amount of anxiety immediately before the intervention and after changing the dressing.
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Method of measurement
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Self-report questionnaire of Burn Specific Pain Anxiety Scale.
Secondary outcomes
1
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Description
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Score pain severity
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Timepoint
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Immediately before and after changing the dressing
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Method of measurement
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Visual Analog Scale for pain severity measurement (VAS)
2
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Description
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The rate of pain anxiety caused by burning dressing
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Timepoint
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Immediately before and after changing the dressing
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Method of measurement
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Burn Specific Pain Anxiety Scale (BSPAS).
Intervention groups
1
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Description
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Intervention group: In the intervention group, the nurse (researcher) performs the acupressure for 15 minutes just before dressing up. First, the first (He gu) point of the right hand then the same point in the left hand and at the end point (Yin tang), Each one is compressed continuously for 5 minutes by researcher for 5 minutes to the standard rate (3-4 kilograms).
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Category
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Treatment - Other
2
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Description
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Control group: In the placebo (control) group patients, With the presence of a researcher near by patient, and just tuch of accupressure points withot any pressure, (in order to remove the psychological effect of the presence of a researcher on the patient's bedside)patients change dressings.
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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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Yes
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Title of funding source
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Mashhad 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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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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The whole potential data is published after being unidentifiable
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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All interested persons
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Under which criteria data/document could be used
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Use will only be allowed with the source.
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From where data/document is obtainable
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Amir hosein soltanpour khazaei
soltanpourah931@mums.ac.ir
+98 9154077916
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What processes are involved for a request to access data/document
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Max 10 days after receiving email
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Comments
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