The purpose of this study was to determine the effects of slow stroke back massage on pain severity and fatigue level of patients receiving chemotherapy for acute leukemia. This study was a blind prospective clinical trial with random assignment. Inclusion criteria included being 18-50 years old, pain and fatigue severity 3 or more (on the basis of numeric rating scale) before intervention, the patients should have been under chemotherapy and exclusion criteria included absence in two sessions of massage therapy, discharge or death of the patient, and the patient's unwillingness to continue to participate in the study. 60 patients with acute leukemia were treated with slow stroke back massage for one month (three 10-minute sessions per week) and then pain severity and fatigue level of them were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030221307N1
Registration date:2015-05-13, 1394/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-13, 1394/02/23
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
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Slow Stroke Back Massage on the pain and fatigue severity in the patients with acute leukemia undergoing chemotherapy.
Public title
Effect of the massage therapy on the patients with acute blood cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ages ranging from 18 to 50 years; pain and fatigue severity 3 or more (on the basis of numeric rating scale); no sign of clear and identified pain or fatigue disorders which are recorded in patients' files (pains from lumbar disc, spinal injuries, fractures, etc. and fatigue from Thalassemia, Sickle cell anemia, etc.); not having any background diseases (such as diabetes, peripheral nerves disease); the patients should have been under chemotherapy.
Exclusion criteria: absence in two sessions of massage therapy; discharge or death of the patient; and the patient's unwillingness to continue to participate in the study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Matching on the basis of age and gender.
Random allocation, the first three patients assigning to the intervention group and the second three patients to the control
Before intervention, at the end of each week, after intervention
Method of measurement
Numeric rating scale (NRS)
2
Description
Fatigue severity
Timepoint
Before intervention, at the end of each week, after intervention
Method of measurement
Numeric rating scale (NRS)
Secondary outcomes
1
Description
nausea severity
Timepoint
Before intervention, at the end of each week, after intervention
Method of measurement
Numeric rating scale (NRS)
2
Description
Quality of life
Timepoint
Before and after of intervention
Method of measurement
Short-Form 36 Health Survey (SF-36)
3
Description
Sleep quality
Timepoint
Before and after of intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
4
Description
Mood disturbances
Timepoint
Before and after of intervention
Method of measurement
Beck Depression questionnaire and Spielberg Anxiety questionnaire
5
Description
Sleep disturbance severity
Timepoint
Before intervention, at the end of each week, after intervention
Method of measurement
Numeric rating scale (NRS)
Intervention groups
1
Description
Both groups will receive the routine cares. The intervention group will be treated with slow stroke back massage.
1- The patient sits on a chair and leaned his head on the pillow, 2 - The small rotational movements with the thumb on the neck, 3- To stroke surface the base of the skull to the sacrum with the palm of a hand, and repeat the procedure on the other side of the spine with the other hand, While at it, the first hand moves toward the base of the skull, 4 – To do stoke on shoulder blades with thumb. 5 - Stroke with the thumb on either side of the spine from the shoulders to the waist, 6 - Stroke to sweep the neck to the sacrum with the palms of both hands.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Shfa Hospital
Full name of responsible person
Dr Ahmadzadeh
Street address
Ahvaz Shfa Hospital, University Of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Mr Kouresh Zareia
Street address
Research center, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Assisstant Professor
Other areas of specialty/work
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 3373 8333
Fax
Email
shahrambaraz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mojtaba Miladi
Position
MSc student of nursing
Other areas of specialty/work
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
ahvaz
Postal code
Phone
+98 61 3373 8333
Fax
Email
miladimojtaba@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Mojtaba Miladi
Position
MSc student of nursing
Other areas of specialty/work
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
Fax
Email
miladimojtaba@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)