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IRCT20200307046709N1 IRCT 2022-02-17 Khomein university of medical science The effect of foot reflexology on pain and constipation in patients with irritable bowel syndrome The effect of foot reflexology on pain and constipation in patients with irritable bowel syndrome referred to Imam Reza Clinic in Khomein 2022-04-21 anticipated 64 Complete https://irct.ir/trial/61578 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: -, 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 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. N/A Irritable Bowel Syndrome. Intervention 1: 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. Intervention 2: Control group: Patients in the control group applied pressure-free foot surface massage to simulate interventions similar to the intervention group. Yes - There is a plan to make this available What will be shared: All information can be shared after identifying individuals When: Start data access after printing results To whom: Academic and industrial researchers Conditions: After obtaining permission from the main executor of the project Where to obtain: Mohammad RostamKhani Email: Moh.rostamkhani1993@gmail.com How to obtain: You will receive a reply after sending the email as soon as it is read Comments:
public Mohhamad Rostamkhani
Khomein university of medical science
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 1534 moh.rostamkhani1993@gmail.com Khomein university of medical science scientific Mohammad rostamkhani
Imam Khomeini Hospital, Beheshti Boulevard
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4633 1534 moh.rostamkhani1993@gmail.com The university of Khomein Iran (Islamic Republic of) 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. 20 years 50 years Both unwillingness to continue research for any reason Pregnancy during the study Feeling uncomfortable doing research Treatment - Other Treatment - Other 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. Control group: Patients in the control group applied pressure-free foot surface massage to simulate interventions similar to the intervention group 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. Method of measurement: "Constipation Assessment Scale"، "Visual Analgesia Scale". Khomein university of medical science Approved 2022-01-15 Ethics Committee of Khomein university of Medical Sciences Quds Boulevard، Khomein university of Medical Sciences Khomein Markazi Iran (Islamic Republic of)