Protocol summary

Study aim
Determining the effect of scheduled appointment on hope and happiness depressed patients.
Design
This clinical trial study was conducted with two parallel random groups and a sample size of 35 people in each group.
Settings and conduct
This study will be carried out in the zahedan psychiatric center. Intervention is 6 scheduled appointment with first-degree relatives.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Depression diagnosis by a professional which is recorded in patients chart. 2- being alert in order to cooperation in planning appointments. 3- Not having visitor restrictions according to physician's opinion. 4- Ability to choose a convenience first_ degree relative to appointment. Exit criteria: Unwillingness to attend in the study.
Intervention groups
In this research, individuals will be placed in two groups of intervention and control. Firstly pre-test will be done for both of groups.The intervention group will be receiving scheduled appointment. The control group will be receiving routine appointment. Finally, post-test will be done for both of groups.
Main outcome variables
The main outcomes of the study are hope and happiness.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180224038839N1
Registration date: 2018-11-14, 1397/08/23
Registration timing: retrospective

Last update: 2018-11-14, 1397/08/23
Update count: 0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Roghaieh Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 0370
Email address
roghaieh.keykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2017-11-20, 1396/08/29
Actual recruitment start date
2017-09-22, 1396/06/31
Actual recruitment end date
2017-11-20, 1396/08/29
Trial completion date
2017-12-03, 1396/09/12
Scientific title
The effect of scheduled appointments on hope and happiness of hospitalized depressed patients.
Public title
The effect of scheduled appointments on hope and happiness of hospitalized depressed patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Depression diagnosis by a professional which is recorded in patients chart Being alert in order to cooperation in planning appointments Not having visitor restrictions according to physician's opinion Ability to choose a convenience first_ degree relative to appointment
Exclusion criteria:
Unwillingness to attend in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated simple randomly by random numbers chart to each group.
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 Zahedan University of Medical Sciences
Street address
Department of Research , Zahedan University of Medical Sciences, Dr. Hesabi Square.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.ZAUMS.REC.1396. 106

Health conditions studied

1

Description of health condition studied
Hospitalized depressed patients
ICD-10 code
F32.2, F33
ICD-10 code description
Severe depressive episode without psychotic symptoms, Recurrent depressive disorder, current episode severe without psychotic symptoms

Primary outcomes

1

Description
Hope
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Schneider's hope Questionnaire

2

Description
Happiness
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Oxford's happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Firstly, the pre-test will be done. Intervention group, will be receiving scheduled appointment (six sessions). Then, the post-test will be done.
Category
Other

2

Description
Control group: Firstly, the pre-test will be done. Control group, will be receiving routine appointment. Then, the post-test will be done.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baharan Hospital
Full name of responsible person
Roghaieh keykha
Street address
Imam Khomeini Street, Opposite the grain Organization
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
roghaieh.keykha@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nor Mohammad Bakhshani
Street address
Department of Research , Zahedan University of Medical Sciences, Dr. Hesabi Square.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
roghaieh.keykha@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Roghaieh Keykha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Psychiatric Nursing Group, Zahedan Nursing and Midwifery Faculty, Mashahir Square, Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816613396
Phone
+98 54 3344 2481
Email
roghaieh.keykha@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Roghaieh Keykha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Psychiatric Nursing Group, Zahedan Nursing and Midwifery Faculty, Mashahir Square, Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
roghaieh.keykha@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Roghaieh Keykha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Psychiatric Nursing Group, Zahedan Nursing and Midwifery Faculty, Mashahir Square, Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
roghaieh.keykha@zaums.ac.ir

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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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