The effect of progressive muscle relaxation training on anxiety, depression and quality of life in cancer patients under chemotherapy in Tabriz Hematology & Oncology Center-1388
The aim of this study is to determine Anxiety, Depression and Quality of life dimensions of cancer patients under chemotherapy and the effect of progressive muscle relaxation training to promote health and improve their Quality of life. Sixty cancer patients under chemotherapy will be selected randomly and will be divided into two groups of intervention and control. To measure Anxiety & Depression, and Quality of life dimensions, HADS and EORTC QLQ-C30 questionnaires will be completed, respectively. Patients will be trained for progressive muscle relaxation in 3-6 case groups, for doing the practical self-help in the hospital and after discharge, 2-3 times a day. One and three months after intervention, questionnaires will be completed again by both groups, and the results will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804172103N3
Registration date:2010-02-19, 1388/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-02-19, 1388/11/30
Registrant information
Name
Iraj Asvadi Kermani
Name of organization / entity
Hematology and Oncology Research Center- Tabriz university of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3844
Email address
asvadikermani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology and oncology research center, Tabriz University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation training on anxiety, depression and quality of life in cancer patients under chemotherapy in Tabriz Hematology & Oncology Center-1388
Public title
The effect of progressive muscle relaxation training on anxiety, depression and quality of life in cancer patients under chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Agreed to participate, Ability to read and write Farsi, Age range of 15-65 years, Receiving minimum 2 cycles of chemotherapy, Having mental health
Inclusion Criteria: receiving pharmacological and non pharmacological interventions for Anxiety and Depression, history of chronic and high risk disease as diabetes, receiving both chemotherapy and radiotherapy, Patients with subscale scores 0-7 (HADS-A), 0-4 (HADS-D), or 0-10 (HADS-T)
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, University Ave.
City
Tabriz
Postal code
Approval date
2009-01-06, 1387/10/17
Ethics committee reference number
5/4/2517
Health conditions studied
1
Description of health condition studied
Training
ICD-10 code
Z50.8
ICD-10 code description
Training in activities of daily living
2
Description of health condition studied
Training
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedure
Primary outcomes
1
Description
Level of anxiety and depresion
Timepoint
1 and 3 Month after intervention
Method of measurement
HADS questionnairre
2
Description
Dimentions of quality of life
Timepoint
1 and 3 Month after intervention
Method of measurement
EORTC QLQ-C30 questionnairre
Secondary outcomes
empty
Intervention groups
1
Description
Patients in 3-6 case groups will be trained to progressive muscle relaxation technique. We advise doing these techniques as self-help in the hospital and after discharge home at least 2 or 3 times a day, especially before night sleep. One and three months after the intervention, HADS and EORTC QLQ-C30 questionnaires again will complete by control and case groups. Progressive relaxation technique: this technique involves alternately tensing and relaxing the muscles and technique session takes approximately 30 minutes. A person may start by sitting or lying down in a comfortable position with the eyes closed; the muscles are tensed (10 seconds) and relaxed (20 seconds) in sequence as per the following progressive pattern: the tension of the lower arms, upper arms, lower legs, upper legs, stomach, chest ,shoulders , neck, mouth, eyes, lower forehead, upper forehead. After doing each of these muscle groups, the patient should feel collectively relaxed and warm.
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Ocology Center,Tabriz, Iran
Full name of responsible person
Dr.Iraj Asvadi Kermani
Street address
Shahid Ghazi Tabatabaei Hospital, Hematology and Oncology research center, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology and oncology research center, Tabriz University of Medical Sciences
Full name of responsible person
Dr Iraj Asvadi Kermani
Street address
Shahid Ghazi Tabatabaei Hospital, Hematology and oncology research center, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology and oncology research center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Iraj Asvadi Kermani
Position
Hematologist and Oncologist- Professor
Other areas of specialty/work
Street address
Shahid Ghazi Tabatabaei Hospital, Hematology and Oncology research center, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 3844
Fax
+98 41 1334 3844
Email
asvadikermani@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sepideh Herizchi Ghadim
Position
Psychiatrist
Other areas of specialty/work
Street address
Shahid Ghazi Tabatabaei Hospital, Hematology and oncology research center, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 3844
Fax
+98 41 1334 3844
Email
sherizchi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehri Golchin
Position
MSN in nursing
Other areas of specialty/work
Street address
Shahid Ghazi Tabatabaei Hospital, Hematology and oncology research center, Tabriz university of medical sciencesTabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 3844
Fax
+98 41 1334 3844
Email
mhsrostami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)