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Protocol summary
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.
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.
The aim of this study is to compare the effectiveness of massage therapy with music therapy on the pain intensityand fatigue intensities in the adult patients with acute leukemia.
هدف این مطالعه، مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد بیماران بالغ مبتلا به لوکمی حاد می باشد.
هدف این مطالعه، مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد و خستگی بیماران بالغ مبتلا به لوکمی حاد می باشد.
هدف این مطالعه، مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد و خستگی بیماران بالغ مبتلا به لوکمی حاد می باشد.
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.
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.
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 intensityand 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.
این مطالعه در بیمارستان شهید بقایی 2 در اهواز، جنوب غربی ایران انجام خواهد شد. شرکت کنندگان به گروه های ماساژ درمانی، موسقی درمانی و گروه مراقبت های معمول تخصیص می یابند. شرکت کنندگان جلسات مداخله ای 15 دقیقه ای مداخلات 3سه بار در هفته بمدت 4 هفته دریافت خواهند کرد. شدت درد با استفاده از مقیاس اندازه گیری عددی در انتهای هر هفته از مطالعه اندازه گیری خواهد شد. همچنین، در این مطالعه پنهان سازی برای پرستارانی که اطلاعات را جمع آوری می کنند انجام خواهد شد.
این مطالعه در بیمارستان شهید بقایی 2 در اهواز، جنوب غربی ایران انجام خواهد شد. شرکت کنندگان به گروه های ماساژ درمانی، موسقی درمانی و گروه مراقبت های معمول تخصیص می یابند. شرکت کنندگان جلسات مداخله ای 15 دقیقه ای مداخلات سه بار در هفته بمدت 4 هفته دریافت خواهند کرد. شدت درد و خستگی با استفاده از مقیاس اندازه گیری عددی در انتهای هر هفته از مطالعه اندازه گیری خواهد شد. همچنین، در این مطالعه پنهان سازی برای پرستارانی که اطلاعات را جمع آوری می کنند انجام خواهد شد.
این مطالعه در بیمارستان شهید بقایی 2 در اهواز، جنوب غربی ایران انجام خواهد شد. شرکت کنندگان به گروه های ماساژ درمانی، موسقی درمانی و گروه مراقبت های معمول تخصیص می یابند. شرکت کنندگان جلسات مداخله ای 15 دقیقه ای مداخلات 3سهسه بار در هفته بمدت 4 هفته دریافت خواهند کرد. شدت درد و خستگی با استفاده از مقیاس اندازه گیری عددی در انتهای هر هفته از مطالعه اندازه گیری خواهد شد. همچنین، در این مطالعه پنهان سازی برای پرستارانی که اطلاعات را جمع آوری می کنند انجام خواهد شد.
General information
Not blinded
Single blinded
notblsingl
1
1
1
1
empty
104
104
empty
2018-12-01, 1397/09/10
2018-12-01 00:00:00
empty
2019-03-18, 1397/12/27
2019-03-18 00:00:00
empty
2019-03-21, 1398/01/01
2019-03-21 00:00:00
empty
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.
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.
empty
در هنگام ثبت کارآزمایی، سهوا متغیر شدت خستگی ثبت نشده بود. در پروپوزال مصوب دانشگاه و سیستم بهسان متغیر شدت خستگی هست. ابزار اندازه گیری شدت خستگی همان ابزار اندازه گیری شدت درد می باشد.
http://behsan.ajums.ac.ir/webdocument/load.action?webdocument_code=1000&masterCode=33011063
در هنگام ثبت کارآزمایی، سهوا متغیر شدت خستگی ثبت نشده بود. در پروپوزال مصوب دانشگاه و سیستم بهسان متغیر شدت خستگی هست. ابزار اندازه گیری شدت خستگی همان ابزار اندازه گیری شدت درد می باشد. http://behsan.ajums.ac.ir/webdocument/load.action?webdocument_code=1000&masterCode=33011063
Effectiveness of Complementary Medicine in Improving pain in Leukemia Patients
Effectiveness of Complementary Medicine in Improving pain and fatigue in Leukemia Patients
Effectiveness of Complementary Medicine in Improving pain and fatigue in Leukemia Patients
اثربخشی طب مکمل بر بهبود درد بیماران لوکمی
اثربخشی طب مکمل بر بهبود درد و خستگی بیماران لوکمی
اثربخشی طب مکمل بر بهبود درد و خستگی بیماران لوکمی
Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain Intensity in the Adult Patients with Acute Leukemia
Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain and fatigue Intensities in the Adult Patients with Acute Leukemia
Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain Intensityand fatigue Intensities in the Adult Patients with Acute Leukemia
مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد بیماران بالغ مبتلا به لوکمی حاد
مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد و خستگی بیماران بالغ مبتلا به لوکمی حاد
مقایسه اثربخشی ماساژ درمانی با موسیقی درمانی بر شدت درد و خستگی بیماران بالغ مبتلا به لوکمی حاد
The outcome assessor nurse and data analyzer have no knowledge of patient grouping.
The outcome assessor nurse and data analyzer have no knowledge of patient grouping.
پرستار ارزیابی کننده پیامدها و آنالیز کننده داده از گروه بندی بیماران اطلاعی ندارند.
پرستار ارزیابی کننده پیامدها و آنالیز کننده داده از گروه بندی بیماران اطلاعی ندارند.
Primary outcomes
#1
Pain intensity more than 3 according to the 0 to 10 numeric rating scale
Pain and fatigue intensities more than 3 according to the 0 to 10 numeric rating scale
Pain intensityand fatigue intensities more than 3 according to the 0 to 10 numeric rating scale
شدت درد بیشتر از 3 طبق مقیاس اندازه گیری عددی 0 تا 10
شدت درد و خستگی بیشتر از 3 طبق مقیاس اندازه گیری عددی 0 تا 10
شدت درد و خستگی بیشتر از 3 طبق مقیاس اندازه گیری عددی 0 تا 10
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.
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.
Pain intensityand fatigue intensities will be measured before intervention. During the four weeks of interventions, pain intensityand 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 65 and week 76), the pain intensityand fatigue intensities will be measured again. Totally, pain intensityand fatigue intensities will be measured for 7 times.
شدت درد قبل از شروع مداخلات اندازه گیری می شود. در طی 4 هفته مداخلات، شدت درد در انتهای هر هفته از مطالعه اندازه گیری می شود. همچنین یک هفته و دو هفته بعد از مداخلات (هفته 6 و هفته 7)، شدت درد مجددا اندازه گیری می شود. مجموعا، شدت درد 7 بار اندازه گیری می شود.
شدت درد و خستگی قبل از شروع مداخلات اندازه گیری می شود. در طی 4 هفته مداخلات، شدت درد و خستگی در انتهای هر هفته از مطالعه اندازه گیری می شود. همچنین یک هفته و دو هفته بعد از مداخلات (هفته 5 و هفته 6)، شدت درد و خستگی مجددا اندازه گیری می شود. مجموعا، شدت درد 7 بار اندازه گیری می شود.
شدت درد و خستگی قبل از شروع مداخلات اندازه گیری می شود. در طی 4 هفته مداخلات، شدت درد و خستگی در انتهای هر هفته از مطالعه اندازه گیری می شود. همچنین یک هفته و دو هفته بعد از مداخلات (هفته 65 و هفته 76)، شدت درد و خستگی مجددا اندازه گیری می شود. مجموعا، شدت درد 7 بار اندازه گیری می شود.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان شهید بقایی 2
Name of recruitment center - Persian: Shahid Baghai 2 Hospital
Full name of responsible person - English: شهرام براز
Full name of responsible person - Persian: Shahram Baraz
Street address - English: Shahid Baghai 2 Hospital., Golestan Ave., Khoramshahr Blvd
Street address - Persian: بلوار خرمشهر، خیابان گلستان، بیمارستان شهید بقایی 2
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3373 8622
Fax:
Email: Shahrambaraz@ajums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Baghai 2 Hospital
Name of recruitment center - Persian: بیمارستان شهید بقایی 2
Full name of responsible person - English: Shahram Baraz
Full name of responsible person - Persian: شهرام براز
Street address - English: Shahid Baghai 2 Hospital., Golestan Ave., Khoramshahr Blvd
Street address - Persian: بلوار خرمشهر، خیابان گلستان، بیمارستان شهید بقایی 2
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3373 8622
Fax:
Email: Shahrambaraz@ajums.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان شهید بقاییShahid Baghai 2 Hospital Name of recruitment center - Persian: Shahid Baghaiبیمارستان شهید بقایی 2 Hospital Full name of responsible person - English: شهرام برازShahram Baraz Full name of responsible person - Persian: Shahram Barazشهرام براز Street address - English: Shahid Baghai 2 Hospital., Golestan Ave., Khoramshahr Blvd Street address - Persian: بلوار خرمشهر، خیابان گلستان، بیمارستان شهید بقایی 2 City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61357-15794 Phone: +98 61 3373 8622 Fax: Email: Shahrambaraz@ajums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Research Center of Nursing Care in Chronic Diseases
Full name of responsible person - Persian: مرکز تحقیقات مراقبت پرستاری در بیماری های مزمن
Street address - English: Ahvaz University of Medical Sciences., Esfand Ave., Golestan Blvd
Street address - Persian: بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3731 1111
Fax:
Email: shahrambaraz@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Badavi
Full name of responsible person - Persian: محمد بدوی
Street address - English: Ahvaz University of Medical Sciences., Esfand Ave., Golestan Blvd
Street address - Persian: بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3731 1111
Fax:
Email: shahrambaraz@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Research Center of Nursing Care in Chronic DiseasesMohammad Badavi Full name of responsible person - Persian: مرکز تحقیقات مراقبت پرستاری در بیماری های مزمنمحمد بدوی Street address - English: Ahvaz University of Medical Sciences., Esfand Ave., Golestan Blvd Street address - Persian: بلوار گلستان، خیابان اسفند، دانشگاه علوم پزشکی اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61357-15794 Phone: +98 61 3731 1111 Fax: Email: shahrambaraz@ajums.ac.ir Web page address:
Protocol summary
Study aim
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.
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 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.
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
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.
Acronym
IRCT registration information
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
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
2018-12-01, 1397/09/10
Actual recruitment end date
2019-03-18, 1397/12/27
Trial completion date
2019-03-21, 1398/01/01
Scientific title
Comparison of the Effectiveness of Massage Therapy with Music Therapy on the Pain and fatigue Intensities in the Adult Patients with Acute Leukemia
Public title
Effectiveness of Complementary Medicine in Improving pain and fatigue 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
Outcome assessor
Data analyser
Sample size
Target sample size:
107
Actual sample size reached:
104
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)
Single blinded
Blinding description
The outcome assessor nurse and data analyzer have no knowledge of patient grouping.
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 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
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.