The aim of this study is to compare the effectiveness of massage therapy with music therapy on the pain intensity in the adult patients with acute leukemia.
Design
Three parallel group randomized trial with concealment for nurses who will be collected data.
Settings and conduct
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 intensity 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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Pain intensity more than 3 according to the 0 to 10 numeric rating scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150302021307N3
Registration date:2018-08-13, 1397/05/22
Registration timing:registered_while_recruiting
Last update:2018-08-13, 1397/05/22
Update count:1
Registration date
2018-08-13, 1397/05/22
Registrant information
Name
Mojtaba Miladinia
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613333333
Email address
miladinia.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain Intensity in the Adult Patients with Acute Leukemia
Public title
Effectiveness of Complementary Medicine in Improving pain in Leukemia Patients
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
107
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Esfand Ave., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.AJUMS.REC.1396.726
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Pain intensity more than 3 according to the 0 to 10 numeric rating scale
Timepoint
Pain intensity will be measured before intervention. During the four weeks of interventions, pain intensity will be measured at the end of each week of study. Also, one week and two weeks after end of the interventions (week 6 and week 7), the pain intensity will be measured again. Totally, pain intensity will be measured for 7 times.
Method of measurement
0-10 Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
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).
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
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.
What processes are involved for a request to access data/document
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.