Determining the effect of reflexology on persistent pain and constipation in patients with irritable bowel syndrome
Design
A randomized, randomized, three-way, clinical trial on 64 patients with irritable bowel syndrome. A quadruple block was used for randomization.
Settings and conduct
People who refer to Imam Reza Clinic in Khomein, receive massage therapy twice a week for 6 weeks. Reflexology is performed using a lubricant to reduce friction on the foot. First, a general massage is performed for 5 minutes on the right foot and then reflexology is performed by performing specific movements of the hands in the area related to the gastrointestinal tract for 10 minutes. After this stage, reflexology is performed with the same technique on the left foot. For patients in the control group, foot pressure massage is applied without pressure to simulate interventions similar to the intervention group.
patients and statistical analysts do not know the members of the intervention and control group and the type of reflexology.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Age 20 to 50 years
Not pregnant
Irritable bowel syndrome according to diagnosis of gastroenterology
No history of any major bowel surgery.
No epilepsy, diabetes, hypertension, kidney and gallstones, hepatitis, heart disease, hyperlipidemia
Do not take medications to control blood sugar, blood pressure, blood thinners, corticosteroids and nonsteroidal anti-inflammatory drugs.
Intervention groups
This intervention is designed to investigate the effect of foot reflexology on pain and constipation in patients with irritable Ward syndrome. The subjects are given massage therapy twice a week (each time for 30-40 minutes) and for 6 weeks. Reflexology is performed using a lubricant (natural sunflower oil) to reduce foot friction.
Main outcome variables
Reflexology
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046709N1
Registration date:2022-02-17, 1400/11/28
Registration timing:prospective
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Mohammad Rostamkhani
Name of organization / entity
Khomein university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 1534
Email address
moh.rostamkhani1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on pain and constipation in patients with irritable bowel syndrome referred to Imam Reza Clinic in Khomein
Public title
The effect of foot reflexology on pain and constipation in patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 20 to 50 years
Not pregnant
Irritable bowel syndrome according to diagnosis of gastroenterology
No history of any major bowel surgery, no epilepsy, diabetes, high blood pressure, kidney and gallstones, hepatitis, heart disease, hyperlipidemia
Do not take medications to control blood sugar, blood pressure, blood thinners, corticosteroids and nonsteroidal anti-inflammatory drugs.
Exclusion criteria:
unwillingness to continue research for any reason
Pregnancy during the study
Feeling uncomfortable doing research
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected based on purpose and randomly (by quadruple block method) are placed in two groups of intervention and control.
Patients are randomly assigned to one of the intervention and control groups by block randomization with quadruple blocks. By assigning the letter A to the intervention group and the letter B to the control group, the six modes AABB, BBAA, BABA, ABBA, BAAB and ABAB are written on separate sheets and thrown into a container and one of the sheets is randomly Is taken out of the container and the composition written on it is written down and that sheet is thrown back into the container. Because the sample size in this study is 80 patients, this operation is repeated 20 times and each time the composition is written on each sheet in the sequence written on the previous sheet. Then, for each letter, a number from one to eighty is assigned in the order of the letters written in a row, and each letter is placed inside an envelope and the letter number is written on the envelope. Each time the disease is selected, one of the envelopes is opened in the order written on the envelope and it is specified that the patient should be in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention performed by the researcher is performed in both intervention and control groups, with the difference that the depth of the massage is different, and because the intervention is performed on both groups, people will not know the details. The division into two groups will not be known, so the two-way study is blind.
Placebo
Not used
Assignment
Other
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khomein university of Medical Sciences
Street address
Quds Boulevard، Khomein university of Medical Sciences
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.KHOMEIN.REC.1400.018
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain and constipation score in the Constipation Assessment Scale and Visual Analgesia Scale
Timepoint
Measurement of pain and constipation before intervention and 6 weeks after reflexology
Intervention group: Patients in the intervention group receive massage therapy twice a week (each time for 30-40 minutes) for 6 weeks. Reflexology is performed using a lubricant (natural sunflower oil) to reduce foot friction. First, a general massage is performed for 5 minutes on the right foot and then reflexology by performing specific movements of the hands in the area of the gastrointestinal tract for 10 minutes (stomach, liver, small intestine, large intestine and solar plexus). After this stage, reflexology is performed with the same technique on the left foot.
Category
Treatment - Other
2
Description
Control group: Patients in the control group applied pressure-free foot surface massage to simulate interventions similar to the intervention group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Mohammad Rostamkhani
Street address
Khomein university of medical sciene، Qods Boulevard
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
moh.rostamkhani1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein university of medical science
Full name of responsible person
Mohammad Rostamkhani
Street address
Khomein university of medical science، Qods Boulevard
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
moh.rostamkhani1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein university of medical science
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
Khomein university of medical science
Full name of responsible person
Mohhamad Rostamkhani
Position
Tutor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khomein university of medical science
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
moh.rostamkhani1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Khomein
Full name of responsible person
Mohammad rostamkhani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Hospital, Beheshti Boulevard
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4633 1534
Email
moh.rostamkhani1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mohammad Rostamkhani
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khomein University of Medical Sciences, Azadi st.
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
moh.rostamkhani1993@gmail.com
Web page address
https://khomeinums.ac.ir/
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
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
All information can be shared after identifying individuals
When the data will become available and for how long
Start data access after printing results
To whom data/document is available
Academic and industrial researchers
Under which criteria data/document could be used
After obtaining permission from the main executor of the project
From where data/document is obtainable
Mohammad RostamKhani
Email: Moh.rostamkhani1993@gmail.com
What processes are involved for a request to access data/document
You will receive a reply after sending the email as soon as it is read