Protocol summary

Summary
The aim of the present study is to determine the effectiveness of clinical religious cares on the anxiety, depression, and spiritual health of hospitalized patients in Qom-Iran. At the beginning of study, the researcher selected 150 hospitalized patients who were not mentally sick and did not receive specific drugs. The samples were divided in two control and intervention groups. A three section questionnaire has been applied to collect data, consisted of 1- demographic data, 2- standardized questionnaire of the Hospital Anxiety and Depression Scale (HADS), and 3-Palutzian& Ellison’s 20-item questionnaire of spiritual health. It measures both religious and existential well-being. Then, the subjects were assigned to control and intervention groups, randomly. At the next stage, intervention of a clergyman was applied as a religious care among the intervention group. Intervention type, content and method were designed with regard to the opinions of the religious experts and colleagues at the pre-test results analysis stage. After the educational intervention, mentioned questionnaires were distributed among the participants once more, aiming at comparing the effects of religious intervention on the test group members’ Anxiety, depression and spiritual health and those of the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014060918022N1
Registration date: 2014-08-22, 1393/05/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Sarallah Shojaei
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3772 2154
Email address
sarallah.shojaei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Religious Clinical Cares by Clergymen on Anxiety and Depression of the Patients and their Spiritual Health
Public title
Effects of Religious Clinical Cares by Clergymen on Anxiety and Depression of the Patients and their Spiritual Health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: hospitalized and mature at the time of study; providing the written consent; capability of responding the questions; lack of anti- anxiety and anti-depression drug use at the time of study; and being Muslim. Exclusion criteria : having mental diseases records or being infected by mental retardation and the underlying disorders; lack of willingness to continue participation in the study; leading to some difficulties for the patients concerning their transferring to other hospitals or releasing; and drug abuse records.
Age
From 15 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Qom university of medical sciences
Street address
Shahid Lavasani st
City
Qom
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
3247

Health conditions studied

1

Description of health condition studied
Anxiety and Depression
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
stress
Timepoint
pre and post intervention
Method of measurement
Questionnaire

2

Description
depression
Timepoint
pre and post intervention
Method of measurement
Questionnaire

3

Description
spiritual health
Timepoint
pre and post intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
disease
Timepoint
post intervention
Method of measurement
clinical observation

Intervention groups

1

Description
the control group receives the usual care of the nurses.
Category
Other

2

Description
providing the participants with clergyman face to face interaction and discussion in the hospital for half or one hour, depending on the patient mood and situation;
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nekoei hospital
Full name of responsible person
Sarallah Shojaei
Street address
Mirzaye ghomi sq; Shahid Taleghani st
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom univesity of medical sciences
Full name of responsible person
Dr.Hosein Saghafi
Street address
Shahid Lavasani st
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom univesity 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
Sarallah Shojaei
Position
PhD student in health education and promotion.
Other areas of specialty/work
Street address
No196, Alley4, 20metri fajr St, 45metri sadoogh Ave
City
Qom
Postal code
37131
Phone
+98 25 3711 8385
Fax
Email
sarallahshojaei@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
Sarallah Shojaei
Position
PhD student in health education and promotion.
Other areas of specialty/work
Street address
No196, Alley4, 20metri fajr St, 45metri sadoogh Ave
City
Qom
Postal code
37131
Phone
+98 25 3291 4108
Fax
Email
sarallahshojaei@gmail.com
Web page address

Person responsible for updating data

Contact

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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