Protocol summary

Summary
One of the approaches to control anxiety and stress in the elderly is education and the provision of adequate information about the disease, control and follow-up the care. This training can be informed and involved one behalf of people with the disease, as is the peer group. This educational approach, according to members of the same features, is a simple and secure learning environment. Patients share their experiences with each other. The importance of reducing anxiety, stress and depression in the elderly led to study the effect of peer education about them. This double blind clinical trial was done between 80 elderly people of sanatoriums of Qom city, randomly in intervention and control groups. In the intervention group, training is done in three sessions during 45 minutes for each of them by peers. In the control group, patients will receive standard care. Inclusion criteria: being aware of time, place and person; s/he should not have the history of proven mental diseases; s/he should have full consent for the study; s/he should not have consume anti-depressants and anti-anxiety drugs; s/he should not took apart in stress training courses over the last 6 months. Exclusion criteria: Occurrence of unexpected events for the patient during the study (Patient dies); s/he should not have the desire to continue the clinical working trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051633998N1
Registration date: 2017-08-05, 1396/05/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Kurosh Jodaki
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9072
Email address
kjodaki@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer education on anxiety, stress and depression in elderly people of sanatoriums of Qom city
Public title
The effect of peer education on anxiety, stress and depression
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: being aware of time, place and person; The patient should be able to understand the contents in the Persian language; s/he should not have the history of proven mental diseases; s/he should not have severe visual and hearing disorders; s/he should have full consent for the study; s/he should not have consume anti-depressants and anti-anxiety drugs; s/he should not took apart in stress training courses over the last 6 months. Exclusion criteria: Occurrence of unexpected events for the patient during the study (Patient dies); s/he should not have the desire to continue the clinical working trial.
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Saheli Street, Qom University of Medical Sciences
City
Qom
Postal code
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.MUQ.REC.1395.160

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified

2

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

3

Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention, 24 hours after treatment and one month after intervention
Method of measurement
DASS 21 questionnaire

2

Description
Stress
Timepoint
Before intervention, 24 hours after treatment and one month after intervention.
Method of measurement
DASS 21 questionnaire

3

Description
Depression
Timepoint
Before intervention, 24 hours after treatment and one month after intervention.
Method of measurement
DASS 21 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the control group patients will receive standard care. If the effectiveness of the intervention is proved, after a study of the control group as well as methods of controlling anxiety, stress and depression will be taught.
Category
Treatment - Other

2

Description
In the intervention group, training is done in three sessions during 45 minutes for each of them by peers. In the first session, patients will introduce to each other while they meet with peer researcher; s/he will explain the purpose of the intervention for patients; then, information about the nature of the symptoms and course of anxiety, stress and depression will be given to them. In the second session, their questions are answered. The successful experiences of their peer will be expressed at the end of each session and exchange their information with them. The third session will start with the questions and the researcher will respond to them. The peer experiences in the field of self-care and follow-up treatment will be available to members of the group; such as physical activity, weight control, diet, activity level social routine and follow-up treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Rehabilitation and care for the elderly.
Full name of responsible person
kurosh jodaki
Street address
Safashahr Street, Qom
City
Qom

2

Recruitment center
Name of recruitment center
Baqiyatallah rehabilitation center and care for the elderly
Full name of responsible person
kurosh jodaki
Street address
Shaheed mahalati square, Panzdah khordad Blvd, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Saghafi
Street address
No. 83, Street No. 4, Safashahr Street, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom.
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
kurosh jodaki
Position
Lecture
Other areas of specialty/work
Street address
School of Allied, Qom University of Medical Sciences Pardis, Qom.
City
Qom
Postal code
Phone
+98 25 3320 9074
Fax
Email
kuroshjodaki@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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