Protocol summary
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Study aim
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The aim of this study is to compare the effectiveness of massage therapy with music therapy on the pain and fatigue intensities in the adult patients with acute leukemia.
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Design
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Three parallel group randomized trial with concealment for nurses who will be collected data.
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Settings and conduct
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This study will be performed at the Shahid Baghai 2 hospital, Ahvaz, southwest of Iran. Participants will be allocated to massage therapy group, music therapy group and usual care group. Participants will be received 15 minutes intervention sessions, thrice weekly for 4 weeks. Pain and fatigue intensities will be measured using the numeric rating scale at the end of each week of study. Also, in this study concealment will be done for nurses who will be collected data.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria to the study: Eighteen years or older, undergoing chemotherapy, at least 3 months after diagnosis of acute leukemia.
Exclusion criteria to the study: Known disorders of pain in their medical history
underlying co-morbidities such as diabetes or other types of cancer.
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Intervention groups
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Participants will be allocated to massage therapy group, music therapy group and usual care group. participants of massage and music therapy groups will be received 15 minutes intervention sessions, thrice weekly for 4 weeks. Also, participants of usual care group will be received 15 minutes bed rest in the privacy room at similar sessions with massage and music groups.
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Main outcome variables
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Pain intensity more than 3 according to the 0 to 10 numeric rating scale
General information
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Reason for update
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At the time of recording the trial, the fatigue intensity variable was not inadvertently recorded. In the proposal approved by the university and Behsan system, the variable of fatigue severity was recorded. The fatigue intensity measuring instrument is the same as the pain intensity measuring instrument.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150302021307N3
Registration date:
2018-08-13, 1397/05/22
Registration timing:
prospective
Last update:
2021-02-05, 1399/11/17
Update count:
1
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Registration date
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2018-08-13, 1397/05/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-11, 1397/05/20
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Expected recruitment end date
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2018-10-12, 1397/07/20
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Actual recruitment start date
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2018-12-01, 1397/09/10
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Actual recruitment end date
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2019-03-18, 1397/12/27
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Trial completion date
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2019-03-21, 1398/01/01
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Scientific title
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Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain and fatigue Intensities in the Adult Patients with Acute Leukemia
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Public title
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Effectiveness of Complementary Medicine in Improving pain and fatigue in Leukemia Patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Eighteen years or older
Undergoing chemotherapy
At least 3 months after diagnosis of acute leukemia
Exclusion criteria:
Known disorders of pain in their medical history
Underlying co-morbidities such as diabetes or other types of cancer
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
107
Actual sample size reached:
104
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The outcome assessor nurse and data analyzer have no knowledge of patient grouping.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-28, 1396/08/06
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Ethics committee reference number
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IR.AJUMS.REC.1396.726
Health conditions studied
1
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Description of health condition studied
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Leukemia
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ICD-10 code
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C91.0
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ICD-10 code description
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Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
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Description
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Pain and fatigue intensities more than 3 according to the 0 to 10 numeric rating scale
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Timepoint
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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.
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Method of measurement
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0-10 Numeric Rating Scale
Intervention groups
1
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Description
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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).
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data file will be subscribed to by the SPSS software format. Only the original outcome can be shared.
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When the data will become available and for how long
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The start of the access period is 10 months after the publication of the results and for 2 months.
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To whom data/document is available
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Data will only be available to researchers working in academia.
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Under which criteria data/document could be used
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Data will only be available for use in review studies and meta-analyzes articles.
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From where data/document is obtainable
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Mojtaba Miladinia
Academic email: miladinia.m@ajums.ac.ir
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What processes are involved for a request to access data/document
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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.
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Comments
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