Determining the effect of Benson relaxation on quality of life in adolescents undergoing bone marrow transplantation
Design
In this randomized clinical trial, patients will be randomly assigned to two groups of 25 people.
Settings and conduct
This study will be performed in Tehran Pediatric Medical Center. 50 patients are randomly divided into two groups of intervention and control. Outcomes are assessed immediately after the intervention and one month after. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 12-18 years, Having the consent to participate in the study, No known psychiatric disorders, dementia and mental retardation. Exclusion criteria: Use of other Complementary therapies
Intervention groups
In the intervention group, Benson relaxation technique will be performed for 20 minutes during two months (daily, twice daily). The control group will be performed no intervention for two months and will receive routine care such as medication.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N49
Registration date:2020-08-28, 1399/06/07
Registration timing:prospective
Last update:2020-08-28, 1399/06/07
Update count:0
Registration date
2020-08-28, 1399/06/07
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson relaxation on quality of life in adolescents undergoing bone marrow transplantation
Public title
The effect of Benson relaxation on quality of life
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 12-18 years
Having the consent to participate in the study.
No known psychiatric disorders, dementia and mental retardation
Exclusion criteria:
Use of other Complementary therapies
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using a randomizer tool (https://www.randomizer.org).
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 Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.007
Health conditions studied
1
Description of health condition studied
Benson relaxation
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Quality of Life
Timepoint
Before, immediately after the end of the study and one month later
Method of measurement
Questionnaire to assess the quality of life of cancer patients at the European Cancer Research and Treatment Center
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In addition to routine care (physiotherapy, light exercise, medication), the Bensone relaxation technique will be performed during two months (every day, twice a day) for 20 minutes. The Benson's relaxation technique includes the following steps: Being comfortable, closing eyes, relaxing all the muscles of the body, breathing slowly.
Category
Prevention
2
Description
Control group: Routine care including joint physiotherapy, light exercise, medication will be performed for patients by health personnel.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Children's Medical Center
Full name of responsible person
Neda Mirbagher
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafshe_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Fatholahi
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
fatholahi_f@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available