Comparing the effect of reflexology and acupressure on acute abdominal pain and depression in patients with colorectal cancer
Design
Clinical trial with parallel groups (reflexology, acupressure), randomized, on 60 patients. For randomization, the block method of 4 was used, as this sequence was produced by the randomization site.
Settings and conduct
Omid, Imam Reza and Qaim hospitals in Mashhad
Participants/Inclusion and exclusion criteria
The diagnosis of colorectal cancer was given by the doctor and the patient's file؛ they can read and write؛ they are between 18 and 60 years old؛ they don't have neurological disorders؛ the Beck-2 Depression Questionnaire score is above 13؛ the presence of mild to severe pain according to the scale visual pain and scoring between 2 and 10
Intervention groups
1. Reflexology
2. Acupressure
Main outcome variables
depression; Acute abdominal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231005059626N1
Registration date:2024-02-11, 1402/11/22
Registration timing:registered_while_recruiting
Last update:2024-02-11, 1402/11/22
Update count:0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Ehsan Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 9151 1234
Email address
khazaeiehsan3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of reflexology and acupressure on acute abdominal pain and depression in patients with colorectal cancer
Public title
Comparing the effects of reflexology and acupressure on acute abdominal pain and depression in patients with colorectal cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of colorectal cancer has been given by the doctor and the patient's file.
Be literate in reading and writing.
The minimum hospitalization period is 4 weeks.
able to receive acupressure and reflexology intervention
Exclusion criteria:
Speech and hearing problems.
Neurological disorders
Lower skeletal disorders
A stressful event in the past 6 months (eg death of a close relative)
Attending a similar study
Using traditional medicine agents to relieve pain and depression 1 week before the start of the exam
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be done in an accessible manner, so that each research unit after entering the study will be based on a random sequence created by the block method of 4. This sequence will be generated by the randomization site and will be kept in a sealed envelope. accepted. The samples will be divided into two acupressure groups and reflexology groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical science
Street address
Daneshghah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.109
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C00-D48
ICD-10 code description
Colorectal cancer
Primary outcomes
1
Description
Depression score in BDI-II questionnaire
Timepoint
Before the intervention and immediately after the last session
Method of measurement
BDI-II depression questionnaire
2
Description
Severity of acute abdominal pain with VAS
Timepoint
Bell from the intervention (baseline) and immediately after each intervention for a period of 4 weeks
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: Reflexology
Category
Rehabilitation
2
Description
second Intervention group: Acupressure
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Ehsan Khazaei fadafen
Street address
Kuhsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3842 6082
Email
omidhos@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Ehsan Khazaei fadafen
Street address
Ahmedabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
3
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ehsan Khazaei fadafen
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
b.emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Musa Mehdizadeh
Street address
East door of Ferdowsi University, Public Relations Department of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 9152
Email
web@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Khazaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshghah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 9151 1234
Fax
Email
khazaeiehsan3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Khazaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshghah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 9151 1234
Fax
Email
khazaeiehsan3@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Khazaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshghah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 9151 1234
Fax
Email
khazaeiehsan3@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information will be published through the article resulting from the project.
When the data will become available and for how long
The information will be published through the article resulting from the project.
To whom data/document is available
The information will be published through the article resulting from the project.
Under which criteria data/document could be used
The information will be published through the article resulting from the project.
From where data/document is obtainable
Administrator's email
What processes are involved for a request to access data/document