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IRCT20130803014251N8 IRCT 2019-01-21 Artesh University of Medical Sciences effects of massage on pain in traumatic patients The effects of light pressure stroking massage with olive oil placebo on pain severity and dose of received analgesic in patients with upper or lower limbs trauma 2019-01-05 anticipated 70 Complete https://irct.ir/trial/36492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The eligible patients will allocate to olive oil group or placebo group using simple randomization method by sealed envelopes, Blinding description: The patients and the nursing staff, who will perform the interventions, will be blinded to the contents of the bottles. Moreover, all assessments and scorings in the two groups will done by a nurse, who will not aware of group assignments. N/A Pain. Intervention 1: Intervention group: The patients in the olive oil group will receive massage with olive oil twice a day for nine consecutive days. For each time, 10 mL of olive oil will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes. Intervention 2: Control group: The patients in the placebo group will receive massage with liquid paraffin twice a day for nine consecutive days. For each time, 10 mL of placebo will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes. Yes - There is a plan to make this available What will be shared: Only a part of patients demographical data and main outcomes will be shared. When: Six months after data publishing To whom: Data will be available only for researchers working on academic and university associations Conditions: Mention of study name Mention of authors name Where to obtain: Zahra Farsi: School of Nursing, AJA University of Medical Sciences, Tehran, Iran How to obtain: At last one month after request Comments:
public Morteza Nasiri
School of Nursing and Midwifery (SA), Namazi Square, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3647 4254 mortezanasiri.or87@yahoo.com Shiraz University of Medical Sciences scientific Morteza Nasiri
School of Nursing and Midwifery (SA), Namazi Square, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3647 4254 mortezanasiri.or87@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age range of 15 to 50 years Being fully conscious and having the ability to read and write in Persian Presence of one limbs trauma which passed a maximum of six hours and at least one hour of its initiation Experience of regional and moderate pain on the trauma site based on visual analog scale (obtaining score of 4 to 7) during the admission time confirmation of appropriate perfusion on the trauma site by a physician 15 years 50 years Both Having infections, bone fractures, dislocations, internal and external bleedings, amputations, and nerve damages on the trauma site during the admission time Having cast or splint on the trauma site Having deep vein thrombosis confirmed by a physician Having diabetes, cardiovascular and musculoskeletal diseases, and gastrointestinal bleedings Taking anti-coagulants, analgesics, tranquilizers or sedatives, and any topical herbal extracts in the past three month History of allergic reactions to any herbal extracts History of addiction, cigarette, and alcohol abuse Acute pain R52.0 Treatment - Other Placebo Intervention group: The patients in the olive oil group will receive massage with olive oil twice a day for nine consecutive days. For each time, 10 mL of olive oil will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes. Control group: The patients in the placebo group will receive massage with liquid paraffin twice a day for nine consecutive days. For each time, 10 mL of placebo will apply on the site of trauma for each 50 cm2 and then the trauma site will massage for five minutes. Pain severity. Timepoint: At first, third, sixth and ninth days of intervention. Method of measurement: Visual analog scale. Dose of received analgesic. Timepoint: At first and ninth days of intervention. Method of measurement: Pain assessment checklist. Artesh University of Medical Sciences Approved 2018-12-09 Ethics Committee of Aja University of Medical Sciences Aja University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)