Protocol summary
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Study aim
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The effect of acupressure in point Qiu on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy is investigated.
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Design
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Clinical trial with control group, with parallel groups, Double blind, randomized from available samples, phase 3 on 70 patients. A block method was used for randomization.
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Settings and conduct
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Patients treated with extracorporeal lithotripsy referred to Shahid Beheshti Hospital in Hamadan were randomly divided into intervention and control groups. The patients in the intervention group lie on the opposite side of the side that has pain, and the exact location of the Qiu point is determined, and force is applied to the spine with the thumb for 3 minutes in the direction of 45 degrees. The strength of the thumb increases gradually and with a regular rhythm until the patient feels warmth in the area.
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Participants/Inclusion and exclusion criteria
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Entry conditions: 1) extracorporeal lithotripsy candidate 2) Age range 18 to 65 years 3) Perform extracorporeal lithotripsy for the first time 4) Signing an informed consent form. No entry conditions: 1) Have previous experience or knowledge of the effects of acupressure 2) Drug addiction 4) Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)
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Intervention groups
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Study groups: Intervention group: In the intervention group, the massage intervention is performed at the Qiu acupuncture point located around the lumbocostal region for 3 minutes. The main outcome variables include the severity of nausea, pain and physiological indicators (including heart rate and blood pressure) of the patients are recorded. Control group: In the control group, massage intervention is performed in the neutral area and around the main point. Patients in both groups receive routine care.
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Main outcome variables
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Nausea, pain and physiological parameters
General information
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Reason for update
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Update based on pilot study results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190524043687N4
Registration date:
2023-05-03, 1402/02/13
Registration timing:
prospective
Last update:
2024-01-10, 1402/10/20
Update count:
1
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Registration date
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2023-05-03, 1402/02/13
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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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2023-05-22, 1402/03/01
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Expected recruitment end date
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2024-03-20, 1403/01/01
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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 acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
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Public title
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The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Eligible for with extracorporeal lithotripsy according to the doctor's diagnosis
Signing an informed consent form
The age range of 18 to 65
Perform extracorporeal lithotripsy for the first time
Exclusion criteria:
Have previous experience or knowledge of the effects of acupressure
Lack of full consciousness
Having mental, visual and auditory disorders and neuropathy
Drug addiction
Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Block randomization method with unequal blocks. will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first, the list of all permutations related to the size of the desired block is determined and then will be randomly as many as the number of samples from the permutation. The method used to generate the random allocation sequence is using a computer. The method of concealing the allocation is to use sealed envelopes.
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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 blind groups in this study include patients and an assistant research collector; in such a way that none of the patients and the data collector will be aware of the allocation of patients to the two intervention and control groups.
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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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2023-04-29, 1402/02/09
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Ethics committee reference number
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IR.UMSHA.REC.1402.058
Health conditions studied
1
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Description of health condition studied
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Urinary stones
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ICD-10 code
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N20.0
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ICD-10 code description
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Calculus of kidney
Primary outcomes
1
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Description
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Intensity of pain
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Timepoint
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Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
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Method of measurement
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Numeric pain rating scale
2
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Description
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Intensity of nausea
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Timepoint
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The intensity of nausea will be evaluated before and after extracorporeal shock wave lithotripsy
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Method of measurement
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Self-report scale
3
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Description
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Heart rate
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Timepoint
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Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
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Method of measurement
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Number of beats per minute - pulse oximeter
4
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Description
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Blood pressure
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Timepoint
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Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
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Method of measurement
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By sphygmomanometer
Intervention groups
1
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Description
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Intervention group: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravanes around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above the patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was first identified by Yunqiao Qiu, a urology specialist at a hospital affiliated with Guangzhou Medical University in China, for treating acute kidney colic pain. This anatomical point is located about the width of one finger (the size of the body is equivalent to 1.3 inches) below and one thumb's width inside the intersection of the twelfth rib and the column of vertebrae (Lumbo-costal point). After observing the location choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 3 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The massage intervention will be repeated once exactly before the commencement of lithotripsy. The results examined in this study are measured before massage and at 1, 10, 20, 30, 40, and 50 minutes.
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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 control group, according to the protocol of the acupressure intervention group, they will receive massage intervention at the neutral point and around the main point.
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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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Hamedan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available