The Effect of Group Hope Therapy on Hope and Adherence to Treatment in Adolescents with Beta Thalassemia
Design
The study is a randomized, single-blind, placebo-controlled clinical trial.
Settings and conduct
Given that the number of adolescents in the present study age range in the Sarver center is 63 people, Therefore, adolescents who meet the inclusion criteria will be randomly assigned to the intervention and control groups.For the intervention group patients, the hope group therapy program will be held for 8 sessions of 60 minutes, two sessions a week with the help of a researcher.Only routine actions will be provided for the control group.Before, immediately and one month after the intervention, adherence to treatment will be assessed using Medanloo Adherence Questionnaire and Hope Snyder Hope Questionnaire in both groups.The analysis will then be performed by intergroup and intergroup comparisons and analysis of variance with repeated measures.
Participants/Inclusion and exclusion criteria
Beta thalassemia major, age 14 to 18 years, minimum primary education, no other chronic comorbidities
Intervention groups
Participants in the study will be assigned to intervention and control groups. For each group of adolescents in the intervention group, the Hope Therapy Program will be designed in 8 sessions of 60 minutes (two sessions per week) based on Snyder studies. For the control group, only routine ward activities (routine nursing care) will be performed during this time.
Main outcome variables
Adherence to treatment and hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190827044634N1
Registration date:2019-11-01, 1398/08/10
Registration timing:registered_while_recruiting
Last update:2019-11-01, 1398/08/10
Update count:0
Registration date
2019-11-01, 1398/08/10
Registrant information
Name
Saeedeh Ilkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5252 7790
Email address
ilkhanis1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Hope therapy on hope and adherence to treatment in adolescents with β-Thalassemia major
Public title
The effect of Hope therapy on thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents with thalassemia major aged 14 to 18 years
Minimum elementary education
Exclusion criteria:
Unwillingness to participate in the study
Other chronic comorbidities
Passing similar courses of hope therapy
Age
From 14 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of the samples to the study groups will be based on days of visit to the clinic (couple and individual) and on a lottery basis.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad School of Nursing
Street address
Ibn Sina St ., Doctora's intersection ., Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.034
Health conditions studied
1
Description of health condition studied
تبعیت از درمان در نوجوانان مبتلا تالاسمی و امید در نوجوانان مبتلا به تالاسمی
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Score obtained from Modanloo treatment adherence questionnaire
2
Description
Hope
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Score obtained from Snyder Hope Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For adolescents in the intervention group, the Hope Therapy program will be conducted in 8 sessions of 60 minutes (two sessions per week) based on Snyder studies and each session will consist of 4 sections. In the first part, about 10 minutes will be discussed of Clients activities and assignments In the last week and encourage people to help each other with problems related to those assignments. In the second part, they will learn about 10 minutes of mental training and hope-related skills that fall into three areas of crossroads and operating goals.The third part, which will take about 30 minutes, will discuss how to apply these skills in one's daily life, and will encourage clients to objectively and explicitly help one another with the use of hope skills, To solve them. In the final 10 minutes of the session, participants will be given an assignment on the topic of the same session, and in the next session before the session begins, the assignments will be reviewed and with the participation of the group members will be discuss about assignments.
Category
Lifestyle
2
Description
Control group: Only routine actions will be provided for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized server polyclinic
Full name of responsible person
Dr. Zahra Badie
Street address
North Shahrivar 17th Street 8., Between 17 Shahrivar Square and Panj rah
City
Mashhad
Province
Razavi Khorasan
Postal code
18746 91679
Phone
+98 51 3366 6065
Fax
+98 51 3364 4551
Email
Sheikh.Hos@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Street- Opposite University Street- Mashhad University of Medical Sciences- Vice-Chancellor for Research & Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
vcresearch @ mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?