The effect of acupressure in point Qiu on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy is investigated.
Design
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.
Settings and conduct
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 5 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.
Participants/Inclusion and exclusion criteria
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)
Intervention groups
Study groups: Intervention group: In the intervention group, the massage intervention is performed at the Qiu acupuncture point located around the lumbocostal region for 5 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.
Main outcome variables
Nausea, pain and physiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190524043687N4
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:1
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Ali Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5861 5962
Email address
asafdari.nu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
Public title
The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
Purpose
Supportive
Inclusion/Exclusion criteria
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)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization method with unequal blocks (for example 2, 4, 6, etc.) 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 selected as many as the number of sample from permutation. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The method of concealing the allocation is to use sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blind groups in this study include patients, an assistant research collector, and a statistician; in such a way that none of the patients and also the data collector were aware of the allocation of patients to the two intervention and control groups and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, will be analyzed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.058
Health conditions studied
1
Description of health condition studied
Urinary stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Intensity of pain
Timepoint
The intensity of pain will be evaluated before and after extracorporeal shock wave lithotripsy
Method of measurement
Numeric pain rating scale (NRS)
2
Description
Intensity of nausea
Timepoint
The intensity of nausea will be evaluated before and after extracorporeal shock wave lithotripsy
Method of measurement
Self-report scale
3
Description
Heart rate
Timepoint
Before intervention, 1, 5, 15, 20, 30 and 60 minutes after the intervention
Method of measurement
Number of beats per minute - pulse oximeter
4
Description
Blood pressure
Timepoint
Before intervention, 1, 5, 15, 20, 30 and 60 minutes after the intervention
Method of measurement
By sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
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 paravans 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 identified by Unicav Q, a urologist, during several decades of activity in connection with the management of acute renal colic pains. In order to find this point, move down and inside the lumboxtal point by the width of a thumb, and the desired point is selected. After observing the location and 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 5 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The results examined in this study are measured before the intervention, immediately after 5, 30 and 60 minutes after the massage.
Category
Treatment - Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Habibullah Mousavi Bahar
Street address
Shahid Beheshti Medical Center, at the beginning of Eram Boulevard, Ghaem Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0447
Email
asafdari.nu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
Borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Fax
Email
asafdari.nu@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available