1) The objective of present study is determining the effectiveness of progressive muscle relaxation on glycosylated hemoglobin and health- related quality of life in patients with type 2 diabetes. 2) Design: The study is a randomized clinical trial with both control and intervention group. 3) Setting and conduct: 100 patients with type 2 diabetes that referred to the clinic will be randomly placed into intervention and control groups. 4) Participants including major eligibility criteria: They are patients with type 2 diabetes. 5) Intervention: The intervention group will be trained PMR during 3 sessions. Patients will do relaxation techniques for 12 weeks, twice a day at home. The control group will not receive any training. 6) Main outcome measures: The primary outcome variable is glycosylated hemoglobin and secondary outcome variable is health related quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021821134N1
Registration date:2015-06-04, 1394/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Maryam Kohandany
Name of organization / entity
Iran school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 6686 7406
Email address
kohandani.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran university of medical science
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of progressive muscle relaxation on glycosylated hemoglobin and health- related quality of life in patients with type 2 diabetes
Public title
Assessing the effect of progressive muscle relaxation on glycosylated hemoglobin and health- related quality of life in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 35 to 65 years; Literacy; A definitive diagnosis of type 2 diabetes by a physician; Oral anti-diabetic medication for at least 1 year; No risk of cardiovascular disease, thyroid disease, intermittent claudication, cerebrovascular accidents, arthritis, diabetic retinopathy, chronic renal failure, chronic pulmonary disease, diabetic foot, severe vision or hearing impairment; Lack of mental illnesses and psychiatric drugs; The absence of sensory perception and communication problems; The absence of limb movement disorders and muscle injury; Not Hype; Lack of relaxation training
Exclusion Criteria: The absence of one of the training sessions for the intervention group; Performance progressive muscle relaxation in the house less than 10 sessions per week (record in the self-report check lists); Drug regime change during the 12-week study (in both control and intervention); The use of other complementary therapies during the study; Lack of learning and skill acquisition procedure; Acute complications of diabetes (such as ketoacidosis and hypoglycemia)
Age
From 35 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Iran university of medical sciences and health services
Street address
Iran university of medical sciences, Shahid Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
105/5864/د/93
Health conditions studied
1
Description of health condition studied
Type2 diabetes
ICD-10 code
ٍE11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
Before and three months after intervention
Method of measurement
Lab Kit
Secondary outcomes
1
Description
Health- related quality of life
Timepoint
Before and three months after intervention
Method of measurement
Diabetes Quality Of Life (DQOL) questionnaire
Intervention groups
1
Description
In intervention group, patients do progressive muscle relaxation to themselves twice a day for three months. In this method patients continuously contract and then relax their muscles while they are listening to the music in CD.
Category
Rehabilitation
2
Description
In control group: Routin activities
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine clinic Firouzgar
Full name of responsible person
Maryam Kohandany
Street address
Firoozgar hospital, Beh Afarin st, Karim khan e Zand st, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran university of medical science
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Iran university of medical sciences, Shahid Hemmat highway, Tehran
City
Tehran
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, Iran 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
School of nursing & midwifery of Iran university
Full name of responsible person
Maryam Kohandany
Position
Post graduate student in nursing
Other areas of specialty/work
Street address
School of nursing & midwifery, Rashid Yasemi St, Valiasr St, Tehran