This study aimed to investigate the effect of stress management training on patient care experience families of patients with schizophrenia, using clinical trial two groups with the control group method. The study population is families of schizophrenic patients hospitalized in Mashhad Ibn Sina Hospital. The most important entry criteria include having reading and writing literacy training and individual recipient of first-degree relatives of the patient and caregiver is most important as the main exit criteria also include the lack of desire to continue the company drgelsat and the absence of more than one training session was. The main carers of 60 patients to non-probability sampling methods in the selected baseline are individual demographic and profile form and a questionnaire to provide patient care experience for all participants. After random assignment of subjects (using the table of numbers) into two groups(intervention and control) the intervention group People are divided into 15 members groups, and stress management training is issued as a lecture, question and answer during 9 sessions (90 minutes) three times a week. For The control group no interference is conducted, but at the end of data collection they are being invited to participate in the one session of stress management training. The research units will be invited, to complete the data collection tool three months after the intervention. Finally, descriptive and analytic statistics will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122731248N2
Registration date:2017-01-10, 1395/10/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
Mahdi Rezaei
Name of organization / entity
Mashhad University of Medical Sciences, Mashhad, Iran
Country
Iran (Islamic Republic of)
Phone
+98 915 805 5323
Email address
rezaeim922@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Stress management Training on the Caregiver Experience in Families Members of Patients
Public title
Stress management Training on the Caregiver Experience in Families Members of Patients with Schizophrenia
Purpose
Health service research
Inclusion/Exclusion criteria
Family entry criteria
Family consent (caregivers) for the study; the person who is trained should be of the close relatives as main caregiver and live with the patient in the same home ; be literate (at least fifth-grade education); be Iranian and live in Mashhad and ; aged 18 at least and 60 at most years old; have no known mental disorder and not use of related drugs ; have no history of drug abuse and criminal record; physical defects, hearing and vision disorders that disrupt the educational process; not have experienced any other crisis such as divorce or death of a loved one during the past six months; not any other chronic mental or physical patient be existed in the family simultaneously .
Inclusion criteria for patients (to determine the research unit):
Schizophrenia should be confirmed by a psychiatrist; At least six months should have passed from the time of diagnosis; Patients should not have any other chronic disease simultaneously; not having cognitive disorders and addiction simultaneously; not having mental illness or disability caused by; should have history of at least one previous hospitalization in psychiatry hospital.
Exclusion criteria:
The family is not willing to continue participation in the meetings; have missed more than one meeting; the main caregivers of patients experience a “major stress” after completion of the training process until the test or take part in similar training courses during the research or is majored in one of medicine, nursing, psychology fields; Failure to participate in the post-test
Age
From 18 years old to 60 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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.MUMS.REC.1394.713
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
f20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Caregiver Experience of Patients
Timepoint
Before and 3 months after intervention
Method of measurement
Standard Szmukler and partners validated and reliable questionnaire translated by doctor Mottaghipour et al.
Secondary outcomes
1
Description
N/A
Timepoint
N/A
Method of measurement
N/A
Intervention groups
1
Description
The intervention consists of six sessions of stress management training which is issued by lecture, question and answer during 9 sessions (90 minutes) three times a week, ) three times a week, in week days and an hour before the meeting.
Category
Lifestyle
2
Description
At the end of the data collection The control group will be invited for Stress management group training to participate in 1 stress management group training session in 10 member groups which is hold by lecture and in person.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences Faculty Nursing & Midwifery
Full name of responsible person
Dr Latifnejad
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Robab Latinejad
Street address
Rzashhr- Rudaki 2 p 237/1
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Rezaee Mahdi
Position
Nurse
Other areas of specialty/work
Street address
Alavi Hospital Mashhad
City
Mashhad
Postal code
Phone
+98 383234681
Fax
Email
www.rezaeim922@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Faculty Member, School of Nursing and Midwifery
Other areas of specialty/work
Street address
Rodaki 26, Rezashahr
City
Mashhad
Postal code
Phone
+98 5105138513258
Fax
Email
www.vaghees@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences Faculty Nursing & Midwifery
Full name of responsible person
Mahdi Rezaee
Position
Master of Science in Psychiatric Nursing Education
Other areas of specialty/work
Street address
Hospital Alavi Mashhad
City
Mashhad
Postal code
Phone
+98 51 3823 4681
Fax
Email
Mahdirezaei922@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)