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IRCT20151228025732N74 IRCT 2022-12-24 Semnan University of Medical Sciences The effect of foot reflexology massage on pain intensity during vascular needle insertion in hemodialysis patients The effect of foot reflexology massage on pain intensity during vascular needle insertion in hemodialysis patients 2022-12-31 anticipated 30 Complete https://irct.ir/trial/67553 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization; Individual; Random Number Tables. Randomized permutation blocks (block 4). Using Sealed Envelope software to generate random number tables, Blinding description: This study is double blind. Outcome assessor and analyzer and participant will be blind (double blind) and will not be aware from grouping. Definition of groups A, B and C will be available to analyzer and outcome assessor. N/A Intensity of pain. Intervention 1: Intervention group 1: In this group, according to the protocol, reflexology massage is performed in three weeks (once a week) for 5 minutes on the sole of the left foot in the area of the solar plexus. After the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured. Intervention 2: Intervention group 2: In this group, according to the protocol, massage is performed for 5 minutes at the opposite point of the solar plexus area on the back of the foot. Intervention 3: Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group. 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 No more information.
public Mohammadreza Asgari
Semnan University of Medical Sciences, Basij Blvd, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 are20935@gmail.com Semnan University of Medical Sciences scientific Mohammadreza Asgari
Semnan University of Medical Sciences, Basij Blvd, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 are20935@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Age 18 years and above Minimum literacy to recognize numbers Performing hemodialysis through an arteriovenous fistula in the left hand At least two months have passed since the start of hemodialysis through the fistula. Absence of simultaneous pain in other parts of the body Male gender 18 years no limit Male Intolerance of pressure and massage in the area of the sole of the left foot The presence of injury or lesion in the massage place Death and travel G89 Pain, not elsewhere classified Treatment - Other Treatment - Other Diagnosis Intervention group 1: In this group, according to the protocol, reflexology massage is performed in three weeks (once a week) for 5 minutes on the sole of the left foot in the area of the solar plexus. After the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured. Intervention group 2: In this group, according to the protocol, massage is performed for 5 minutes at the opposite point of the solar plexus area on the back of the foot. Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group. Pain intensity. Timepoint: Before and after the intervention. Method of measurement: Numeric Pain Rating Scale (NRPS). Semnan University of Medical Sciences Approved 2022-10-10 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)