Protocol summary

Summary
The aim of this clinical trial is to determine the effects of the educational program of positive thinking on sleep quality and hopefulness of Major thalassemia patients. The sample consists of 76 patients of the special diseases ward of Fasa Shariati hospital who enter the study through census and are placed equally in experimental and control groups on the basis of random blocks. Entrance factors includes the age of 18 and over and the ability to read and write, where the exit ones cover the psychological grounds such as great depression, encountering crisis, and being admitted during the last three weeks. The intervention for the experimental group consists of eight sessions of positive thinking education such as lectures, group discussion, clip shows , and sound clips. The control group does not receive any intervention. The data would be collected with Petersburg sleep quality and Schneider hopefulness questionnaires before and one month after the experiment. The expected outcomes include improvements in sleep quality and hopefulness in the patients of the experimental group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010431774N1
Registration date: 2017-07-03, 1396/04/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-03, 1396/04/12
Registrant information
Name
Somayeh Makaremnia
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 3148
Email address
makaremnia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial the effect of positive thinking educational program on the sleep quality and hopefulness of major thalassemia patients
Public title
The effect of educational program concerning the positive thinking on the sleep quality and hopefulness of patients inflicted by major thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:People who are suffering from major thalassemia; are not member of virtual and real groups of positive thinking during the intervention; at least 18 years old. Exclusion criteria: failure to complete the questionnaire in full; mental illness including chronic depression treated with medication; lack of participation in the program is fully; lack the ability to read and write; to deal with major crises such as the death of a relative during the study and over the last 3 months; hospitalization for 48 hours or more
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: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Central Building Shiraz University of Medical Sciences;Zand Ave ;Shiraz.
City
Shiraz
Postal code
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
ir.sums.irec.1396.5

Health conditions studied

1

Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Sleep quality
Timepoint
before and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
hopefulness
Timepoint
before and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

1

Description
Positive thinking
Timepoint
Before and one month after the intervention
Method of measurement
Positive thinking questionnaire

Intervention groups

1

Description
Intervention group: The program includes training on positive thinking positive thinking skills for 8 sessions of two hours for groups of 8-12 people will be done. If any of the members can not participate in scheduled meetings will make it possible to compensate in other groups. The number of participants will be at the discretion of the investigator. Overall content, including familiarity with positive thoughts and beliefs about themselves, others, life and future through clips and audio files with the same focus.
Category
Other

2

Description
Control group: Receives no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
TheSpecific Disease Ward Of Fasa Shariati Hospital
Full name of responsible person
Somayeh Makaremnia
Street address
Shariati Hospital, Fasa, Fars, Iran
City
Fasa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Chaman Reza
Street address
Shiraz UniversityOf Medical Sciences، Zand Ave، Shiraz;Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maksremnia Somayeh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، zand ave، Shiraz، Iran
City
Shiraz
Postal code
00987136474254
Phone
+98 71 3647 4254
Fax
Email
makaremnia@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Dr Zahra Khademian
Position
Assistant Professor
Other areas of specialty/work
Street address
Fatemeh (PBUH) School of Nursing and Midwifery, Namazi Square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
zahrakhademian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Makaremnia Somayeh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences;zand ave; Shiraz;Iran
City
Shiraz
Postal code
Phone
+98 917 616 1710
Fax
Email
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
Loading...