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IRCT20221223056899N1 IRCT 2022-12-28 Birjand University of Medical Sciences The effect of acupressure on anxiety, fatigue and blood pressure The effect of acupressure on anxiety, fatigue and blood pressure in patients undergoing hemodialysis 2023-02-20 anticipated 105 Complete https://irct.ir/trial/67585 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All sample people are divided into three equal groups by simple random method. First, 105 cards (the same as the sample size) will be prepared. Then, one of the letters A, B or C will be written on each card. These cards will be placed inside a box so that nobody can see the cards inside the box. After the researcher shuffles the cards, the patients are asked to randomly pick a card from the box (the selected cards are not returned to the box after selection). In this way, people are placed in three groups of 35 people A, B and C. In this way, three cards are prepared and one of the numbers 1, 2 and 3 will be written on each card. Number 1, 2 and 3 will belong to intervention, sham and control respectively. These cards are placed in a box and after mixing, the researcher will randomly select one card for each group (the selected cards will not return to the box after selection), Blinding description: The patients are divided into three intervention groups, sham points and control. The patients of the intervention group receive acupressure in real points and sham acupressure spheres in false points. The patients do not know the exact location of the points. In this study, the researcher's help in completing All questionnaires will be used for blinding and to prevent bias in the results. In this way, the researcher's help will be unaware of the groupings and the type of interventions that are carried out in each group and by each person. 3 Renal failure. Intervention 1: The patients of acupressure group are massaged at PC6 or Nei Guan points, GV 20 and ST36 (both legs) in total (9 points) by the thumb pulp of the therapist's hand and at the beginning of dialysis, which does not interfere with the patient's dialysis. The pressure level is 3 to 4 kg for 10 minutes. It will be done three times a week for 4 weeks. Follow-up is also done in the dialysis sessions, which the patient is definitely present. Intervention 2: Control group: Sham points group patients will receive acupressure on false points where applying pressure does not have any soothing effect, in the form of massage on two SP9 points that are inside the leg at the junction of the tibial shaft and the tibial condyle in a depression (to instead of ST36) and point CV24, which is exactly between the chin and lower lip on the front midline of the body in the middle of the distance between lip and chin (instead of GV20) and point SP6 (instead of LV3) and point KI27 (instead of GB 20) and point TW 6 (instead of PC6) will be performed by the therapist's thumb pulp with a pressure of 3 to 4 kg for 10 minutes three times a week for 4 weeks. Intervention 3: Control group: In the control group, no intervention will be performed on the patients. 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 Patient information is private.
public Toktam Soleimani
No.24,Ghaem29/1Ave
Torbat-Heydariyeh Iran (Islamic Republic of) 9518656667 +98 51 5223 9677 soleimanitoktam1374@gmail.com Birjand University of Medical Sciences scientific Toktam Soleimani
No.24,Ghaem29/1Ave
Torbat-Heydariyeh Iran (Islamic Republic of) 9518656667 +98 51 5223 9677 soleimanitoktam1374@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Dialysis at least 2 times a week and each time for 3-4 hours Dialysis treatment for at least 6 months willingness to cooperate in the study no use of sedatives such as benzodiazepines Hearing ability and speech No limb amputation or wound at the place of massage No contraindications to acupressure Age at least 18 years 18 years no limit Both Hospitalization of the patient during intervention Suffering from hemodynamic complications in most dialysis sessions The occurrence of a severe stressful event, such as the death of a first-degree relative Travel or death of the patient Unwillingness to continue cooperation in the study Performing kidney transplant or peritoneal dialysis during research N17-N19 Treatment - Other Treatment - Other Treatment - Other The patients of acupressure group are massaged at PC6 or Nei Guan points, GV 20 and ST36 (both legs) in total (9 points) by the thumb pulp of the therapist's hand and at the beginning of dialysis, which does not interfere with the patient's dialysis. The pressure level is 3 to 4 kg for 10 minutes. It will be done three times a week for 4 weeks. Follow-up is also done in the dialysis sessions, which the patient is definitely present. Control group: Sham points group patients will receive acupressure on false points where applying pressure does not have any soothing effect, in the form of massage on two SP9 points that are inside the leg at the junction of the tibial shaft and the tibial condyle in a depression (to instead of ST36) and point CV24, which is exactly between the chin and lower lip on the front midline of the body in the middle of the distance between lip and chin (instead of GV20) and point SP6 (instead of LV3) and point KI27 (instead of GB 20) and point TW 6 (instead of PC6) will be performed by the therapist's thumb pulp with a pressure of 3 to 4 kg for 10 minutes three times a week for 4 weeks. Control group: In the control group, no intervention will be performed on the patients. Reducing the level of anxiety. Timepoint: Before the start of the intervention, after the end of the intervention and one month after the end of the intervention. Method of measurement: Spielberger anxiety questionnaire. Reducing the fatigue level of hemodialysis patients. Timepoint: Before and after the intervention. Method of measurement: Paper fatigue questionnaire. Birjand University of Medical Sciences Approved 2022-03-09 Ethics Committee of Birjand University of Medical Sciences No.24,Ghaem29/1 Ave Torbat-Heydariyeh Razavi Khorasan Iran (Islamic Republic of)