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IRCT20170116031972N7 IRCT 2019-07-10 Kerman University of Medical Sciences The effect of accupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis The comparative effect of acupressure and cryotherapy on the pain of the injection in the arteriovenous fistula in the patients under hemodialysis referred​ to the clinical centers of Kerman University of Medical Sciences, in 2019 2019-07-23 anticipated 50 Complete https://irct.ir/trial/40632 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: samples will be randomly assigned into two blocks of 25 samples, 25 samples in acupressure/cryotherapy group and 25 samples in cryotherapy/acupressure group by Permuted Block Randomization. N/A acute postprocedural pain of needle entry into the arteriovenous fistula. Intervention 1: Cryotherapy/Acupressure intervention group: Session 1: routine care and no intervention will take place. Session 2: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula . After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure. Session 3: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before​ the needle is inserted. Intervention 2: Acupressure/Cryotherapy intervention group: Session 1: routine care and no intervention will take place. Session 2: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before the needle is inserted. Session 3: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula. After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure. 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 I have not decided yet - its release plan is still undecided.
public Seyed Javad Hosseini
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3342 7901 hosseini4173@yahoo.com Kerman University of Medical Sciences scientific Mahlagha Dehghan
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 m_dehghan86@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Being conscious Having the ability of verbal communication 3 months passed the time of fistula embedding At least 6 months passed the time of hemodialysis Initiation Having an active medical document (Weekly three sessions and each session for 3 to 4 hours of hemodialysis) In case of diabetes, their diabetes has been controlled (FBS range from 70 to 150 mg/dl and BS in the range of 120 to 250 mg/dl) 18 years no limit Both Receiving a sedative or opiate drug for 8 hours before hemodialysis Excessive pain in other body parts The presence of skin problem, insensibility, neuropathic disorders and peripheral vascular disease at the site of access to the vessels G89.18 Other acute postprocedural pain Other Other Cryotherapy/Acupressure intervention group: Session 1: routine care and no intervention will take place. Session 2: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula . After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure. Session 3: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before​ the needle is inserted. Acupressure/Cryotherapy intervention group: Session 1: routine care and no intervention will take place. Session 2: Acupressure will take place. The researcher, using a hand thumb, will diagonally rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure for 10 minutes for periods of 2 minutes compressive massage and 15 seconds rest before the needle is inserted. Session 3: Cryotherapy will take place, as the researcher will put a cube-shaped piece of ice inside a gauze bandage, and then place it inside a plastic bag. The researcher will place the ice cube between the thumb and the index finger on the opposite hand with no fistula. After 10 minutes (2 minutes compressive massage and 15 seconds rest periodically), before the needle is inserted into the arterial-venous fistula, The researcher will rub the Hugo point (between the thumb and the index finger in the opposite hand) with average pressure. Pain score in numerical visual analogue pain scale. Timepoint: Session 1: Patient's pain will be measured under normal care conditions and after entering and fixing hemodialysis arterial-venous needles. Session 2: Patient's pain will be measured after cryotherapy and entering and fixing hemodialysis arterial-venous needles. Session 3: Patient's pain will be measured after acupressure and entering and fixing hemodialysis arterial-venous needles. Method of measurement: The numerical visual analogue pain scale. Kerman University of Medical Sciences Approved 2019-06-24 Ethics committee of Kerman University of Medical Sciences Ebnesina St, Jahad Blvd, Somaye Crossroad, Kerman kerman Kerman Iran (Islamic Republic of)