This randomized clinical trial will be conducted on 40 patients undergoing stem cell transplantation in Amir Kola Children’s hospital in Babol. Inclusion criteria included age older than 18 years; diagnosed with multiple myeloma; leukemia and lymphoma; lack of neuromuscular disorders; lack of sedation assumption; no history of Benson relaxation; Stem cell transplantation for the first time; Exclusion criteria included serious physical complaints such as severe infection; severe pain and acute bleeding; loss of consciousness; the fourth-grade graft versus host disease. After approving of the study by sciences vice chancellor of Mazandaran University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 20 patients in experimental and 20 in control group. Demographic questionnaire and Brief Fatigue Inventory (BFI) will complete by all patients on admission day. The experimental group will receive supportive intervention One day after admission and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in Bone Marrow Transplantation unit. Patients in experimental group will do Benson relaxation for 20 minute, twice a day during fifteen days from the stem cell transplant day in the intervention group. No intervention will be made in control group. Brief Fatigue Inventory (BFI) will complete by all patients eight days and two weeks after the transplant after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091624047N1
Registration date:2015-12-13, 1394/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-13, 1394/09/22
Registrant information
Name
Hedayat Jafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7268
Email address
hjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-09-07, 1394/06/16
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Benson relaxation effect on fatigue level in patients after hematopoietic stem Cell transplant.
Public title
Relaxation effect on fatigue in patients after stem cell transplant.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included age older than 18 years; diagnosed with multiple myeloma; leukemia and lymphoma; lack of neuromuscular disorders; lack of sedation assumption; no history of Benson relaxation; Stem cell transplantation for the first time; Exclusion criteria included serious physical complaints such as severe infection; severe pain and acute bleeding; loss of consciousness; the fourth-grade graft versus host disease.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari
City
Sari
Postal code
4815696869
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
Patients receiving hematopoietic stem cells
ICD-10 code
c81-c96
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
Fatigye
Timepoint
Admission time, 8 days after transplantation and 2 weeks after transplantation
Method of measurement
Brief Fatigue Inventory
Secondary outcomes
empty
Intervention groups
1
Description
After approving of the study by sciences vice chancellor of Mazandaran University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 20 patients in experimental and 20 in control group. Demographic questionnaire and Brief Fatigue Inventory (BFI) will complete by all patients on admission day. The experimental group will receive supportive intervention One day after admission and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in Bone Marrow Transplantation unit. Patients in experimental group will do Benson relaxation for 20 minute, twice a day during fifteen days from the stem cell transplant day in the intervention group. Brief Fatigue Inventory (BFI) will complete by all patients eight days and two weeks after the transplant after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
Category
Behavior
2
Description
No intervention will be made in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirKola Chidren's hospital
Full name of responsible person
Somayeh Hassanpour
Street address
Non-Communicable Pediatric Diseases Research Center, Babol Univercity of Medical Sciences,Babol, IR Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr. Ahmahali Enayati
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Mazandaran University of Medical Sciences.
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
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Hassanpour
Position
MSC in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 11 3234 7344
Fax
Email
som.hassanpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat Jafari
Position
Assistant Professor, scientific committee
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 11 3379 5555
Fax
Email
hedayat2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Hassanpour
Position
MSC in critical care nursing
Other areas of specialty/work
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran
City
Sari
Postal code
4815696869
Phone
+98 11 3234 7344
Fax
Email
som.hassanpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)