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Comparison the effect of spiritual care and routine care on the level of happiness in elderly inhabitant in retirement home

Protocol summary

Study aim
Determining the effect of spiritual care package on the level of happiness of elderly residents of Sabzevar Madar home in 2018
Design
A double-blind, randomized clinical trial with community-based control group and parallel group design. In this study 40 elderly people randomly assigned into intervention group (spiritual care) and control (routine care).
Settings and conduct
The research environment is Madar's elderly retirement home in Sabzevar. A total of 40 eligible people are selected. And they randomly divided into two intervention (receiving spiritual care) and control (routine care) groups. Before and after the intervention, the Happiness Questionnaire will be filled for two groups. Participants and statistical adviser will be unaware of the involvement of the elderly in the intervention or control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 60 years old; Ability to speak in Persian; at least one month stay in the nursing home; No concurrent participation in similar researches (related to research topic). Non- Inclusion criteria: not believing in Islam; Visual or auditory impairment that causes performance impairment; Mental disorders; Experiencing an stressful event in the last three months (such as losing the spouse or other close relatives).
Intervention groups
Intervention group: Receiving spiritual care including active listening and instilling hope on a daily basis, from one person to the elderly, listening to seniors' speeches and concerns, arranging facilities for worship, using supportive systems (attendance of the clergy, attendants, charities). Control group: in this group, elders receive no extra intervention. In other word, they receive routine daily care provided in the nursing home.
Main outcome variables
Happiness score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181101041522N1
Registration date: 2018-12-08, 1397/09/17
Registration timing: registered_while_recruiting

Last update: 2018-12-08, 1397/09/17
Update count: 0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
toktam ayyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7278
Email address
ayyaari.t@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of spiritual care and routine care on the level of happiness in elderly inhabitant in retirement home
Public title
The effect of spiritual care on the level of elderly happiness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in the study aged over 60 ability to speak persian minimum one month stay at a nursing home lack of co-operation in research related to research topic
Exclusion criteria:
Not believing in Islam Visual impairment to the extent that causes performance impairment Hearing impairment to the extent that impairs performance impairment Mental disorders with regard to the elderly medical records Experience of stressful events in the last three months (such as losing the spouse or other close relatives)
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, four permuted blocks consisted of the English letters A,B,C,D. The letters B, and A would be denoted the intervention group, and C, and D would be denoted the control group. The blocks are selected randomly and blindfolded. Each block is then deleted, and the next random block is selected. With each block, the entrance order to the intervention group or the control group is determined. Assumingly; block D, A, C, and B would be meant that the second, and fourth subjects are entered in the intervention group and the first, and third subjects are entered in the control group. The patients were divided into two equal groups, with 20 patients in the intervention group and 20 patients in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in research and data analyst are unaware of the allocation of individuals to the control or intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
No.1, Farhangian 15, Farhangian Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.MEDSAB.REC.1397.051

Health conditions studied

1

Description of health condition studied
Happiness of the elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Happiness score in the Oxford Happiness Questionnaire
Timepoint
At the beginning of the study (before the intervention) and after the intervention and two weeks after the end of the intervention
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: delivering spiritual care daily from 9 o'clock to 12 o'clock for 4 weeks including: active listening and protectionist presence (daily presence beside the elderly and listening to his or her talk and concerns), supporting religious ceremonies (providing facilities and helping the elderly to practice worship) and using Supportive systems (clergy presence, visitors and charities), Instilling hope (encouraging the elderly to recount and record strengths and pleasant memories of life related to the positive and successful events of their life).
Category
N/A

2

Description
Control group: In this study, the control group does not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Madar elderly home
Full name of responsible person
Mahdi Zabihollahi
Street address
22 Bahman Street, Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Phone
+98 51 4421 3817
Email
ayyaari.t@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Street address
Deputy of Research and Technology; Sabzevar University of Medical Sciences; after Anonymous Martyrs tomb; Shohadaye Hastei Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Phone
+98 51 4464 7278
Email
ayyaari.t@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Toktam Ayyari
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Farhangian15, Farhangian street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Phone
+98 51 4423 8100
Email
ayyaari.t@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Toktam Ayyari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Farhangian15, Farhangian street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Phone
+98 51 4464 7278
Fax
Email
ayyaari.t@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Toktam Ayyari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Farhangian15, Farhangian street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9611761311
Phone
+98 51 4464 7278
Fax
Email
ayyaari.t@gmail.com

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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