Protocol summary

Summary
The overall goal: the effectiveness of group therapy hope on happiness in hemodialysis patients; the effectiveness of group therapy on mental health hope hemodialysis patients. Specific goals: to determine the average patients happiness score in the experimental group and control at baseline; determine and compare average Patients happiness score in the experimental group and control at the end of the study; comparing average hemodialysis patients happiness score in both experienced and control groups at the beginning and end of the study; comparing average hemodialysis patients mental health score in both experienced and control groups at the beginning and end of the study experience. Study design: randomized, triple-blind, multicenter, phase one trial. Study Population: patients admitted at Shahid Rahnamom and Shahid Sadogy hospitals. Inclusion criteria: willingness to participate in research. Exclusion criteria: the patient is critically ill. Sample size: 44 people. Intervention: medical therapy sessions 8 sessions 5/1 hour, week 2 meeting as a group (other than on dialysis) runs. Each session consists of four parts. In the first 20 minutes of last week's activities and assignments will be discussed. In the second part, 20-minute mental training and skills, hoping to learn. The third part takes about 40 minutes to apply these skills in daily living practices are discussed. In the last 10 minutes of the next meeting will be presented homework session. Study outcome: increased happiness hemodialysis patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120425361N1
Registration date: 2015-12-23, 1394/10/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Naeime baghshahi
Name of organization / entity
Yazd Sadoghi shahid university
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 9807
Email address
baghshahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi Yazd University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group hope therapy on hemodialysis patients’ happiness
Public title
The effectiveness of group hope therapy on hemodialysis patients’ happiness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: normal mental health; desire to participate in the study; having at least three months hemodialysis; age between 18 to 65 years old. Exclusion criteria: recent history life stressors such as the death of relatives and first degree relatives, divorce, bankruptcy, etc.; the patient is ill and unable to participate in group counseling program; an impairment of hearing, vision and speech.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd Shahid Sadoghi University of Medical Sciences
Street address
Yazd Shahid Sadoghi University of Medical Sciences, Shahid Bahonar square
City
Yazd
Postal code
8916978477
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.SSU.REC.1394.90

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Happiness
Timepoint
After intervention
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

1

Description
General Health
Timepoint
Before and after intervention
Method of measurement
General Health Questionnaire

Intervention groups

1

Description
intervention group: education hope therapy, 8 session 90 minute
Category
Other

2

Description
controle group: not intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahnamon hospital
Full name of responsible person
Naeime Baghshahi
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Miss Morshedian
Street address
Yazd Shahid Sadoghi University of Medical Sciences, Shahid Bahonar squ.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoghi 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
Yazd Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Naeime Baghshahi
Position
MSc
Other areas of specialty/work
Street address
Yazd Shahid Sadoghi University of Medical Sciences, Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 3626 0001
Fax
Email
www.baghshahi@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Dr Farahnaz Farnia
Position
PhD
Other areas of specialty/work
Street address
Yazd Shahid Sadoghi University of Medical Sciences, Safaei
City
Yazd
Postal code
Phone
+98 35 3824 5777
Fax
Email
farnia@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Naeime Baghshahi
Position
MSc
Other areas of specialty/work
Street address
Yazd Shahid Sadoghi University of Medical Sciences, Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 3626 0001
Fax
Email
www.baghshahi@ssu.ac.ir
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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