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IRCT20150302021307N3 IRCT 2018-08-13 Ahvaz University of Medical Sciences Effectiveness of Complementary Medicine in Improving pain and fatigue in Leukemia Patients Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain and fatigue Intensities in the Adult Patients with Acute Leukemia 2018-08-11 anticipated 107 Complete https://irct.ir/trial/31413 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization was performed by a research assistant and with use of the computer-generated random numbers. We gave to the each participant an identification number from 001 to 107, and then was used the randomizer form to generate 1 set of 107 non-unique, unsorted numbers with a range from 1 to 3. Finally, 107 participants were randomly allocated to the three study groups (35 participants in the massage therapy group, 33 participants in the music therapy group and 39 participants in the usual care group). Also, in this study concealment will be done for nurses who will be collected data, Blinding description: The outcome assessor nurse and data analyzer have no knowledge of patient grouping. N/A Leukemia. Intervention 1: First intervention group: Participants of massage therapy group will be received 15 minutes slow-stroke back massage (SSBM) sessions, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Totally, 12 sessions will be performed for each participant (225 minutes massage therapy). Intervention 2: Second intervention group: Participants of music therapy group will be received 15 minutes music sessions, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Totally, 12 sessions will be performed for each participant (225 minutes music therapy). Participant will be listened to self-selected instrumental music, using a headphone connected to the CD player. Intervention 3: Usual care group: Participants of usual care group will be received 15 minutes bed rest in the privacy separate room without environmental stimulation, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Moreover, during bed rest period, a oncology nurse who had communication skills will be stayed with the participant and to speak about their condition, treatment process. Totally, 12 sessions will be performed for each participant. Yes - There is a plan to make this available What will be shared: The data file will be subscribed to by the SPSS software format. Only the original outcome can be shared. When: The start of the access period is 10 months after the publication of the results and for 2 months. To whom: Data will only be available to researchers working in academia. Conditions: Data will only be available for use in review studies and meta-analyzes articles. Where to obtain: Mojtaba Miladinia Academic email: miladinia.m@ajums.ac.ir How to obtain: First, send an e-mail to the author and mention the purpose of obtaining the information. In the absence of a problem, you will receive information one to three weeks later. Comments:
public Mojtaba Miladinia
Nursing faculty, Ahvaz University of Medical Science, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3333 3333 miladinia.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mojtaba Miladinia
Nursing faculty., Ahvaz University of Medical Sciences., Golestan Blv
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3333 3333 miladinia.m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Eighteen years or older Undergoing chemotherapy At least 3 months after diagnosis of acute leukemia 18 years no limit Both Known disorders of pain in their medical history Underlying co-morbidities such as diabetes or other types of cancer C91.0 Acute lymphoblastic leukemia [ALL] Rehabilitation Rehabilitation Rehabilitation First intervention group: Participants of massage therapy group will be received 15 minutes slow-stroke back massage (SSBM) sessions, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Totally, 12 sessions will be performed for each participant (225 minutes massage therapy). Second intervention group: Participants of music therapy group will be received 15 minutes music sessions, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Totally, 12 sessions will be performed for each participant (225 minutes music therapy). Participant will be listened to self-selected instrumental music, using a headphone connected to the CD player. Usual care group: Participants of usual care group will be received 15 minutes bed rest in the privacy separate room without environmental stimulation, thrice weekly (every other day) for 4 weeks in addition to the usual cares. Moreover, during bed rest period, a oncology nurse who had communication skills will be stayed with the participant and to speak about their condition, treatment process. Totally, 12 sessions will be performed for each participant. Pain and fatigue intensities more than 3 according to the 0 to 10 numeric rating scale. Timepoint: Pain and fatigue intensities will be measured before intervention. During the four weeks of interventions, pain and fatigue intensities will be measured at the end of each week of study. Also, one week and two weeks after end of the interventions (week 5 and week 6), the pain and fatigue intensities will be measured again. Totally, pain and fatigue intensities will be measured for 7 times. Method of measurement: 0-10 Numeric Rating Scale. Ahvaz University of Medical Sciences Approved 2017-10-28 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz University of Medical Sciences, Esfand Ave., Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)