Protocol summary

Study aim
Determining the effectiveness of human givens Therapy on reducing anxiety, stress, and depression in elderly residents of nursing homes and determining the effectiveness of human givens Therapy on improving the physical, cognitive, social and self-care dimensions and life satisfaction and improving sexual issues and reducing depression and anxiety dimensions of quality of life Elderly residents of nursing homes
Design
The sample size is 30 people. Random assignment to intervention and control groups, simple randomization, individual, manual selection.
Settings and conduct
A semi-experimental study with a pre-test and post-test, along with a control group and the effectiveness of human deposit therapy on the scores of the components of psychological disturbance and the quality of life of the elderly living in Ghamar bani hashem nursing homes.
Participants/Inclusion and exclusion criteria
The elderly living in nursing homes aged between 60 and 75 years,Literacy for reading and writing,Not receiving medical and psychological treatments during the last six months
Intervention groups
Seven treatment sessions for human givens, once a week and the duration of each session is 45 minutes،The control group does not receive any intervention.
Main outcome variables
psychological distress ؛ quality of life

General information

Reason for update
Acronym
HGT
IRCT registration information
IRCT registration number: IRCT20230105057059N1
Registration date: 2023-05-06, 1402/02/16
Registration timing: registered_while_recruiting

Last update: 2023-05-06, 1402/02/16
Update count: 0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
Masoumeh Kalantarabharpour
Name of organization / entity
The University of semnan
Country
Iran (Islamic Republic of)
Phone
+98 23 3526 3555
Email address
m.kalantar.a@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-19, 1402/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of human givens therapy on psychological distress and quality of life of the elderly living in a nursing home
Public title
The effectiveness of human givens therapy on psychological distress and quality of life
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing Age range from 60 to 75 years
Exclusion criteria:
receiving medical and psychological treatments during the last six months
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,individual,manual selection.The list of seniors who meet the entry criteria will be numbered and the test group will be completed by lottery, and then the lottery will be done again to complete the proof 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 semnan University ofMedical Sciences
Street address
Floor 13,Block A,Ministry of Health &Medical Education Headquarters,Between Zarafshan&South Falamak,Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.SEMUMS.REC.1401.253

Health conditions studied

1

Description of health condition studied
Psychological distress
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
psychological distress
Timepoint
Before the start and after the end of therapy
Method of measurement
kessler psychological distress questionnaire scale k10

2

Description
quality of life
Timepoint
Before the start and after the end of therapy
Method of measurement
the LEIPAD standard quality of life questionnaire for the elderly

Secondary outcomes

empty

Intervention groups

1

Description
Seven treatment sessions for human givens, once a week and the duration of each session is 45 minutes.Therapy sessions are done in groups. The content of the sessions includes establishing therapeutic communication, assessing the condition and severity of the disorder, examining and evaluating emotional needs and their role in the occurrence of disturbance. Providing the task of identifying needs such as the need for security. Investigating the unsatisfied needs of every elderly person, how emotions arise due to exposure to stimuli with mental patterns, presenting the task of identifying the motivating stimuli, paying attention to inherent resources such as (empathy, past memories, dreaming of the thinking mind, etc.), investigating the irrational thoughts of the elderly, analyzing General information with the approach of hope and optimism and analysis of the way of satisfying individual needs and resources in the nursing home and creating a new story for living and thinking in different and successful ways.
Category
Treatment - Other

2

Description
Control group:They do not receive intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghamar bani hashem care center for the elderly
Full name of responsible person
Abolghasem Khatibzade
Street address
Shahid mofatteh First of Ave ,Shohada Sq,Damghan Town
City
Damghan
Province
Semnan
Postal code
3671684867
Phone
+98 23 3524 2551
Fax
+98 23 3523 4543
Email
mkabharpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of semnan
Full name of responsible person
Hossein ehsani
Street address
Mahdishar Facualty of psychologyand Educational sciences,Darban Ave,Mahdishar Town
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3153 3030
Fax
+98 23 3362 6888
Email
Psychology@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of semnan
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
The University of semnan
Full name of responsible person
Masoumeh Kalantarabharpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 13,Aflak11 Bldg,mokremy alley,emam Quarter ,damghan Town
City
Damghan
Province
Semnan
Postal code
3671693144
Phone
+98 23 3526 3555
Fax
Email
m.kalantar.a@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of semnan
Full name of responsible person
Masoumeh Kalantarabharpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 13,Aflak11 Bldg,mokremy alley,emam Quarter ,damghan Town
City
Damghan
Province
Semnan
Postal code
3671693144
Phone
+98 23 3526 3555
Fax
Email
m.kalantar.a@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of semnan
Full name of responsible person
Masoumeh Kalantarabharpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 13,Aflak11 Bldg,mokremy alley,emam Quarter ,damghan Town
City
Damghan
Province
Semnan
Postal code
3671693144
Phone
+98 23 3526 3555
Fax
Email
m.kalantar.a@semnan.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
Not applicable
Data Dictionary
Not applicable
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