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Impact of spiritual interventions, designed based on five items of Richard& Bergin's Theistic spiritual strategies, on family function and sense of coherence of cancer patients caregivers.

Protocol summary

Summary
Study aimed to determine the impact of Spiritual intervention on family functioning and sense of coherence in the caregivers of patients with cancer, and based on five items of Richard& Bergin's Theistic spiritual strategies, that includes prayer, spiritual connection and visualization techniques, the Compassionate, in consultation with religious leaders, using intuition and inspiration combined with four connection with God, self, others and nature designed . In order to gather information, after the establishment in shariati hospital, and research samples selection based inclusion criteria, the samples were randomly divided into two intervention and control groups. Then questionnaires in three stages before the spiritual intervention , immediately after the 6 meeting spiritual intervention and a month after the intervention by the participants in the study will be completed in two groups. spiritual intervention is done during the 6 meeting in small groups caregivers having a person with cancer in family; passing at least two months and maximum 6 months from the time of diagnosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110730758N1
Registration date: 2017-06-05, 1396/03/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-05, 1396/03/15
Registrant information
Name
Zahra Momeni Keleshteri
Name of organization / entity
Shahid beheshti school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 44044735
Email address
zahramomeni@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research assistant of shahid beheshti University of medical sciences
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of spiritual interventions, designed based on five items of Richard& Bergin's Theistic spiritual strategies, on family function and sense of coherence of cancer patients caregivers.
Public title
Impact of spiritual interventions on family function and sense of coherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having a person with cancer in family; passing at least two months and maximum 6 months from the time of diagnosis. Exclusion criteria: Patients with recurrent disease.
Age
From 77 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Shahid Beheshti School of Nursing and Midwifery Ethics Committee
Street address
School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SBMU.PHNM.1395.467

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms

Primary outcomes

1

Description
Family Function
Timepoint
Before intervention& after intervention& one month after intervention
Method of measurement
Family Assesment Device(FAD)

2

Description
Sence of Coherence
Timepoint
Before intervention& after intervention& one month after intervention
Method of measurement
SOC-13

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Spiritual intervention is done during the 6 meeting in small groups of 11 caregivers. every week a meeting will be held on certain days.The duration of each session is 45 to 60 minutes.
Category
Lifestyle

2

Description
Control group: Do not receive any intervention, after the end of the study they are given educational booklets.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Zahra Momeni
Street address
Shariati Hospital, Jalal Ale Ahmad Hwy, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of of Shahid Beheshti University of Medical Sciences
Street address
Near the Ayatollah Taleghani Hospital, Shahid Erabi Street, Yaman Strret, Shahid Chamran 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 of of Shahid Beheshti 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
Shahid Beheshti School of Nursing & Midwifery
Full name of responsible person
Zahra Momeni
Position
Nurse
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Fax
Email
zahramomeni@sbmu.ac.irzahramk67@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Zahra Momeni
Position
Nurse
Other areas of specialty/work
Street address
Tehran, Vali Asr prayer intersection, School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 8820 2521
Fax
Email
zahramk67@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Zahra Momeni
Position
Nurse
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4411 4685
Fax
Email
zahramk67@yahoo.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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