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IRCT20230205057335N1 IRCT 2023-02-08 Kerman University of Medical Sciences Investigating the effect of abdominal massage on constipation and laboratory indicators in hemodialysis patients referred to Kerman hemodialysis centers in 2023 Investigating the effect of abdominal massage on constipation and laboratory indicators in hemodialysis patients 2023-04-09 anticipated 262 Complete https://irct.ir/trial/68442 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to allocate the studied subjects to intervention and control groups, the block randomization method is used, the block randomization method is a method in which the participants are randomly placed in blocks in terms of cas score, in the following By using simple randomization method and using R software, half of the people from each group will be placed in the intervention group and the other half will be placed in the control group, Blinding description: This study is double blind. The data analysts do not know which data are related to the intervention and control groups; And the participants do not know which intervention or control group they were placed in. For the intervention group, abdominal massage is performed, while for the control group, a simple abdominal touch is performed. N/A constipation. Intervention 1: Intervention group: They receive the intervention three times a week for one month. (The intervention will be done one hour after the start of dialysis and during dialysis when the patient is connected to the dialysis machine for dialysis and the patient is in a good state in terms of hemodynamic conditions and is ready to receive massage).The researcher (woman) and another person (man) will complete the massage course under the supervision of a traditional medicine specialist. The massage lasts 15 minutes. Before the massage, the patient's privacy will be respected and the patient's privacy will be maintained. The way to perform the massage is that the massage is done half an hour before feeding on an empty stomach due to the greater comfort of the patient. In this way, the patient is placed in a lying position on the back so that the legs are slightly bent from the knees and the head is at an angle of 15 to 30 degrees. The covering of the massage area is removed from the anterior upper surface of the iliac crest to below the lower ribs of the chest and other parts of the body remain covered. Then the masseur will be placed on the right side and in front of the lower level of the patient's pelvis and will start the massage. The massage will start clockwise from the beginning of the ascending colon and continue towards the horizontal colon and finally to the end of the descending colon. Massage in Swedish massage style including touching or stroking movements, exfoliation with head movements, vibration and kneading movements with palms or needing will be done twice for each patient. It should be noted that no oil or lotion is used for the massage. Also, in order to prevent the distortion of information, performing abdominal massage at home is controlled by the patient. Intervention 2: Control group: In the sham group, a simple palpation of the abdomen is performed, and immediately after the sessions, the condition of constipation and laboratory indicators and the adequacy of dialysis will be evaluated again in both groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not any information.
public Mahdieh Daneshfar
Kerman University of Medical Sciences,Medical University of Campus, Haft- Bagh - Alavi Highway, Kerman
KERMAN Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 MAHDIEH.DANESHMAND6430@GMAIL.COM Kerman University of Medical Sciences scientific Mahdieh Daneshfar
Kerman University of Medical Sciences,Medical University of Campus, Haft- Bagh - alavi Highway, Kerman
KERMAN Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 Mahdieh.daneshmand6430@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having a minimum age of 18 years and a maximum of 70 years Having a history of dialysis for at least six months Having a file in the dialysis department of the desired centers Performing at least three times of dialysis per week and four hours each time Not having skin disease, advanced heart failure and stroke The basis of the patient's medical record Constipation according to the CAS constipation severity scale (score greater than 8) Not using anti-constipation drugs do Not having a digestive disorder such as irritable bowel syndrome, fissure anus volvulus, rectal prolapse, intestinal obstruction according to the statement The patient, the patient's file and, if necessary, an examination by a doctor 18 years 70 years Both Interrupting the study or not completing the intervention (more than two sessions) due to transfer to the acute care department and hospitalization in that department, traveling or not participating in massage therapy sessions for two sessions. • Performing transplant surgery and any surgery in the abdominal area that prevents massage therapy. k59.0 constipation Treatment - Other N/A Intervention group: They receive the intervention three times a week for one month. (The intervention will be done one hour after the start of dialysis and during dialysis when the patient is connected to the dialysis machine for dialysis and the patient is in a good state in terms of hemodynamic conditions and is ready to receive massage).The researcher (woman) and another person (man) will complete the massage course under the supervision of a traditional medicine specialist. The massage lasts 15 minutes. Before the massage, the patient's privacy will be respected and the patient's privacy will be maintained. The way to perform the massage is that the massage is done half an hour before feeding on an empty stomach due to the greater comfort of the patient. In this way, the patient is placed in a lying position on the back so that the legs are slightly bent from the knees and the head is at an angle of 15 to 30 degrees. The covering of the massage area is removed from the anterior upper surface of the iliac crest to below the lower ribs of the chest and other parts of the body remain covered. Then the masseur will be placed on the right side and in front of the lower level of the patient's pelvis and will start the massage. The massage will start clockwise from the beginning of the ascending colon and continue towards the horizontal colon and finally to the end of the descending colon. Massage in Swedish massage style including touching or stroking movements, exfoliation with head movements, vibration and kneading movements with palms or needing will be done twice for each patient. It should be noted that no oil or lotion is used for the massage. Also, in order to prevent the distortion of information, performing abdominal massage at home is controlled by the patient. Control group: In the sham group, a simple palpation of the abdomen is performed, and immediately after the sessions, the condition of constipation and laboratory indicators and the adequacy of dialysis will be evaluated again in both groups. Constipation. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: CAS Constipation Severity Scale. Laboratory index of potassium. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the information provided in the laboratory sample before and after the intervention. Laboratory index of calcium. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the information provided in the laboratory sample before and after the intervention. Sodium laboratory index. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the information provided in the laboratory sample before and after the intervention. Laboratory index of phosphorus. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the information provided in the laboratory sample before and after the intervention. Adequacy of hemodialysis. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the information provided in the laboratory sample before and after the intervention. Kerman University of Medical Sciences Approved 2023-01-09 Ethics committee of Kerman university of medical sciences Unit. 5, Block B, Bldg Havashenasi, St Shahid kazerooni, Blv Imam reza KERMAN Kerman Iran (Islamic Republic of)