To Compare the Effectiveness of Acupressure Technique and Diaphragmatic Breathing Exercise on Nausea and Vomiting in Cholecystectomy Patients.
.
Design
A Quasi Experimental Comparative Design on non random in patient with cholecystectomy with minimum sample size of 30 for each group will be used ; the total size 90 patient enrolled between December 2023 to September 2024
Settings and conduct
The study was conducted in Imam Al-Hussein medical city Hospital For Surgical unit For Cholecystectomy patient in Karbala Governorate, Iraq.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patient with cholecystectomy who have nausea and vomiting. More than 18 years old patient who complete surgery of cholecystectomy during the first 6 hour of surgery.
Exclusion criteria:
patient who declined to enroll in the study. patient with physical disability. patient who has amputation in upper extremity. Patient who has discontinuing to intervention. patient who had on mechanical ventilation and/or in intensive care for more than 48 hours.
Intervention groups
Data will be collected using the pre- and post-test methods. After assessing the level of nausea and vomiting, the sample will be allocated into three groups: (Group 1) performed the acupressure technique on PC6 using elastic wrist bands with a 1 cm-diameter plastic button stud for 6 hours. Group 2: diaphragmatic breathing exercise, for 6 hours. The researcher assesses the severity of nausea and vomiting after six hours to determine the effect of this exercise on both nausea and vomiting. All groups were evaluated prior to the intervention (post-test assessment) after six hours by using the Rhodes index to assess nausea. Group 3: control group without any intervention.
Main outcome variables
Reducing Nausea and Vomiting .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240111060680N1
Registration date:2024-02-13, 1402/11/24
Registration timing:registered_while_recruiting
Last update:2024-02-13, 1402/11/24
Update count:0
Registration date
2024-02-13, 1402/11/24
Registrant information
Name
Bushra.A. jasem Jasem
Name of organization / entity
Kerbala University
Country
Iraq
Phone
+964 771 434 0379
Email address
bushra.a@s.uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-31, 1402/11/11
Expected recruitment end date
2024-03-01, 1402/12/11
Actual recruitment start date
2024-02-10, 1402/11/21
Actual recruitment end date
2024-06-25, 1403/04/05
Trial completion date
2024-07-01, 1403/04/11
Scientific title
Effect of Acupressure Technique and Diaphragmatic Breathing Exercise on Nausea and Vomiting in Cholecystectomy Patient: A comparative study
Public title
Effect of Acupressure Technique and Diaphragmatic Breathing Exercise on Nausea and Vomiting in patient with Cholecystectomy :A Clinical Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Those who are Surgical Diagnosed with Cholecystectomy
Patient between Age 18-and above , Able to perform intervention.
Exclusion criteria:
Patient who have Discontinuing to Intervention-
Patient who had on Mechanical Ventilation and/or in Intensive Care for More than 48 hours
Patient who have Amputation in Upper Extremity
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
30
Actual sample size reached:
90
More than 1 sample in each individual
Actual sample size in each individual:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Quasi experimental design purposive sample comparative study with a minimum sample size of 30 for each group will be used. The total sample size would be 90 subjects
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in College of Nursing at University of Kerbela
Street address
Al-Baladia Distract
City
Karbala
Postal code
10053
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
4626
Health conditions studied
1
Description of health condition studied
Cholecystectomy patient
ICD-10 code
R11
ICD-10 code description
Nausea and Vomiting
Primary outcomes
1
Description
The primary outcome variable is the level of nausea and vomiting post operative in patient cholecystectomy that can be changed based on Acupressure Technique and diaphragmatic breathing exercises.
Timepoint
Before intervention and 6 hours after intervention.
Method of measurement
The Rhodes index and visual analog scale will be used to assess the level of nausea vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group1 perform the acupressure technique on pc6 with wrist band were used for this technique which are elastic wrist bands with plastic button 1cm in diameter stud ,The Stud of the wrist band pressing upon PC6acupoint it is located on the anterior surface of the forearm ,about three finger 'width up from the wrist crease ,between the tendon of the palmaris longus and flexior carpi radialis The patient wearing wrist bands at pc6 bilaterally starting at 0 hour postoperative and Removed for 6 hours .Group 2 Diaphragmatic Breathing Exercise starting through inhale the nose slowly to take as much as possible amount of air ,while the mouth was closed and keep it on for few second paying close attention to the abdomen-hand movement with each breath while keeping the hand on the chest steady and then exhale slowly through the mouth for a few seconds in a circle shape, The patient in this group were instructed to perform diaphragmatic breathing exercise for 2-3 min every two hour for 6 hours , in all groups were evaluated prior to the intervention (post-test assessment) after six hours by using the Rhodes index and visual analog scale for assess nausea and vomiting level.
Category
Treatment - Other
2
Description
Control group received no intervention ;instead they received pretest and post test assessment after 6 hours ,as did the other groups ,and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after 6 hours by using the Rhodes index and Visual Analog Scale .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Al-Hussein Medical City Hospital
Full name of responsible person
Bushra Abd Ali Jasem
Street address
Al-Baladia Distract
City
Karbala
Postal code
10053
Phone
+964 771 434 0379
Fax
+964 771 434 0379
Email
bushra.a@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerbala University
Full name of responsible person
Bushra Abd Ali Jasem
Street address
Al-Baladia Distract
City
Karbala
Postal code
10053
Phone
+964 771 434 0379
Fax
+964 771 434 0379
Email
bushra.a@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
University of Kerbala
Full name of responsible person
Bushra Abd Ali Jasem
Position
Lecture
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Baladia Distract
City
karbala
Province
karbala
Postal code
10053
Phone
+964 771 434 0379
Email
bushra.a@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Bushra Abd Ali Jaesm
Position
Lecture
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Baladia Distract
City
Karbala
Province
Karbala
Postal code
10053
Phone
+964 771 434 0379
Email
bushra.a@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Person responsible for updating data
Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Bushra Abd Ali Jaesm
Position
Karbala
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Baladia Distract
City
Karbala
Province
Karbala
Postal code
10053
Phone
+964 771 434 0379
Email
bushra.a@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The data will be the result of Cholecystectomy Patient with Nausea and Vomiting Level in Both the Control and Intervention Groups .
When the data will become available and for how long
God Willing,Once the Article is Published, The Data will be Available after 6 Months of Publication. If the Article will be Published in a Subscribed Journal, The Data Will be Available after One Year because of the Policy of The Subscribed Journals.
To whom data/document is available
With Academic Nurses and any Researcher who is Interested in the Data.
Under which criteria data/document could be used
The Data Could be Used after Getting permission Via Email. Also, Users need to Acknowledge The Owner.
From where data/document is obtainable
Users can Ask for the Data and Permission via email. is the Corresponding Author. He will contact whoever he requests the information from. His email is bushra.a@s.uokerbala.edu.iq Bushra Abd Alli works at the University of Kerbala/College of Nursing. The address is Al- Baladia district, Kerbala, Iraq.
What processes are involved for a request to access data/document
What processes are involved for a request to access data/document
Users Can ask for The Data and Permission via email. Bushra Abd Ali Jasem is The Corresponding Author. He will Contact whoever he Requests the Information from. His email is bushra.a@s.uokerbala.edu.iq