Protocol summary

Study aim
To compare the effect of using hot bag versus  acupressure technique on constipation among patients with stroke
Design
A quasi-experimental Design:to Determine if Applying Hot Water Bag and Acupressure Technique can Effect on Constipation among Patient with Stroke . This Study was Initiated from 4th October 2023 to 4th July 2024
Settings and conduct
Kerbala/Iraq at Neurological Medical Units of Imam Al-Hussein Medical City. Imam Al-Hussein Medical City is Considered the largest Health Care Facility in Kerbala.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients with Acute Stroke. Patients have Problem with (Constipation). Patients who Given an Agreement to participated in the study. Exclusion Criteria: Patients who had Cognition Disorder. Patients with Bowel Incontinence Those who had Change in Level of Copiousness. Patients who had visual or Auditory Impairment
Intervention groups
Participants were separated fairly into three groups: [intervention group (G1, G2; n =25)] and [control group (G3; n=25)]. The intervention group instructed to apply acupressure technique was applied for 9minutes on average, 3minutes on each acupressure points of li4l., li3 and sj6, twice a day—3days in total. The patient was placed in the setting position. Acupressure points were determined using the patient’s own fingers and marked with a pencil. All participants continued to receive their conventional stroke program. hot water pack application improves gastrointestinal motility, rubber water bag with a fluffy cover filled with boiled tap water [80°C] and placed on the abdomen four time a day for 30 min each time for three days.
Main outcome variables
Reduce Constipation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240204060895N1
Registration date: 2024-02-29, 1402/12/10
Registration timing: retrospective

Last update: 2024-02-29, 1402/12/10
Update count: 0
Registration date
2024-02-29, 1402/12/10
Registrant information
Name
Aqila Almosaway
Name of organization / entity
Kerbala univercity
Country
Iraq
Phone
+964 773 642 8597
Email address
aqilamohmmed952@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-23, 1402/12/04
Expected recruitment end date
2024-02-23, 1402/12/04
Actual recruitment start date
2024-02-23, 1402/12/04
Actual recruitment end date
2024-02-23, 1402/12/04
Trial completion date
2024-02-23, 1402/12/04
Scientific title
Effect of Hot Water Bag and Acupressure Technique in Constipation among Patients with Stroke
Public title
Effect of Hot Water Bag and Acupressure Technique in Constipation among Patients with Stroke
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Acute Stroke that are Admitted to the Neurological Wards at Imam Al-Hussein Medical City Patients have Problem with Bowel Movement (Constipation) Patients who Given an Agreement to Participated in the Study. More than18years Old.
Exclusion criteria:
Patients who had cognition disorder Patients with bowel incontinence Those who had change in level of coniousness. Patients who had visual or auditory impairment
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Actual sample size reached: 75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
aqila almosaway
Secondary trial Id
75652
Registration date
2024-02-23, 1402/12/04

2

Registry name
aqila almosaway
Secondary trial Id
75652
Registration date
2024-02-26, 1402/12/07

3

Registry name
aqila almosaway
Secondary trial Id
75652
Registration date
2024-02-26, 1402/12/07

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in College of Nursing at University of kerbala
Street address
Hay Almowadfieen
City
Kerbala
Postal code
10053
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
23017

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
The primary outcome variable is the identify .constipation and treatment by hot water bag and acuprssure
Timepoint
Before Intervention and 3 Days After Intervention
Method of measurement
Wexner questionnaire scale and modifying constipation assessment scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This interventional procedure is instructions on how to improve bowel movement and prevent constipation for patients with stroke. Therefore, this interventional protocol includes basic procedure (hot water bag and acupressure technique), all patients were explained the procedure and written informed consent. Participants were separated fairly into three groups: [intervention group (G1, G2; n =25)] and [control group (G3; n=25)]. The intervention group instructed to apply acupressure technique was applied for 9minutes on average, 3minutes on each acupressure points of li4located right and left hands. Find in the soft skin between thumb and index finger on the top of hand, li3 This point is located in the depression of the radial side of the index finger, proximal to the head of the second metacarpal bone. and sj6, located at the back of the arm, twice a day—3days in total. The patient was placed in the setting position. Acupressure points were determined using the patient’s own fingers and marked with a pencil. All participants continued to receive their conventional stroke program. hot water pack application improves gastrointestinal motility, rubber water bag with a fluffy cover filled with boiled tap water [80°C] and placed on the abdomen four time a day for 30 min each time for three days. Control group A normal pack was applied to the participants in the control group. Normal packs were prepared in the same manner as the hot bag except the bag were filled tap water and left in the experimental room for 1 hour to reach room temperature (25.1 °C ± 2.5 °C).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussan Medical City, Neurological Department
Full name of responsible person
Aqila Mohmmed hashem
Street address
Hay Almowadfieen
City
Kerbala
Postal code
10053
Phone
+964 773 642 8597
Email
aqelah.m@s.uokerbala.edu.iq

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerbala University
Full name of responsible person
Aqila Mohmmed hashem
Street address
Hay Almowadfieen
City
Kerbala
Postal code
10053
Phone
+964 773 642 8597
Email
aqelah.m@s.uokerbala.edu.iq
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
Kerbala university
Full name of responsible person
Aqila Mohmmed hashem
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hay Almowadfieen
City
Kerbala
Province
Kerbala
Postal code
10053
Phone
+964 773 642 8597
Email
aqelah.m@s.uokerbala.edu.iq

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerbala university
Full name of responsible person
Aqila Mohmmed hashem
Position
lecture
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hay Almowadfieen
City
Kerbala
Province
Kerbala
Postal code
10053
Phone
+964 773 642 8597
Email
aqelah.m@s.uokerbala.edu.iq

Person responsible for updating data

Contact
Name of organization / entity
Kerbala University
Full name of responsible person
Aqila Mohmmed hashem
Position
lecture
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hay Almowadfieen
City
Kerbala
Province
Kerbala
Postal code
10053
Phone
+964 773 642 8597
Email
aqelah.m@s.uokerbala.edu.iq

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
Yes - There is 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 results of the TCNS that measure patients' constipation 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. aqila almosaway is the corresponding author. she will contact whoever he requests the information from. her email is aqelah.m@s.uokerbala.edu.iq, works at the University of Kerbala/College of Nursing. The address is al bahadlaa, Karbala, 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. aqila almosaway is the corresponding author. she will contact whoever he requests the information from. her email is aqelah.m@s.uokerbala.edu.iq,
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