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Trial Title:
The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms
NCT ID:
NCT06011278
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Assignment to the experimental and control groups will be made by an independent
statistician to avoid bias and ensure confidentiality. Thus, selection bias will be
controlled by making random assignment and hiding the randomization.
In the study, participant and researcher will not be blinded. Blinding will not be
possible because the researcher follows the participants and parents on a daily basis and
is aware of the intervention. The data will be coded as 'A' and 'B' by the researcher and
transferred to the computer. It is recommended that all stages of randomized controlled
trials be conducted according to the Consolidated Standards of Reporting Trials
(CONSORT). In this context, the study will be conducted on the basis of the CONSORT 2017
(Updated Guidelines for Reporting Randomized Parallel Group Studies) guideline during the
randomization stages of this study.
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Community Supported Videos
Description:
Volunteers will be asked to create a maximum of three minutes of content that will
psychosocially strengthen and motivate pediatric oncology patients. In the videos,
information will be given about not using words such as cancer/oncology/tumor and not
including private and personal information. Videos will be created in such a way that
they can be edited, merged or deleted accordingly. The applications of volunteer
individuals will be made through social media (Instagram), the collection of these videos
will be followed in accordance with the voluntary consent forms, and the volunteers will
be informed in detail about the use of visual and verbal data.
Children will be sent videos featuring different volunteers each week. The content of the
videos will be controlled by the child clinical psychologist and researchers.
Inappropriate videos will not be included in the research.
Arm group label:
Community-supported videos
Summary:
The effects of psychosocial support on the disease process have been studied with many
different groups and diseases, and even the psychosocial support needed by the family of
the child with a chronic disease has been the subject of research, but studies focusing
directly on the needs of the child have been very limited. Although it is seen in the
existing literature that studies such as art and play therapy or educational programs
have been carried out to improve the attitudes of pediatric oncology patients towards
their own diseases, no study has been found that investigated the effects of
social/social support in pediatric oncology patients. In order to contribute to this
limitation in the literature, this study aimed to examine the effects of
community-provided psychosocial support videos on the attitudes and symptoms of pediatric
oncology patients.
Detailed description:
Cancer can affect every individual regardless of age and gender, causing individuals to
experience a situation they were not used to before. People may not be able to apply the
coping mechanisms they know or they may not find enough coping strength in themselves.
This situation can cause individuals to experience emotions such as fear, anxiety and
stress. At the beginning of the periods when the diagnosis of cancer is particularly
difficult to cope with, comes the period of adolescence and adolescence, which covers the
age range of 10-18, in which we plan to conduct the research.
During this period, relationships with people other than parents gained importance; the
interest is on peers and non-peer social relationships; It is a developmental period in
which there are sudden fluctuations in emotions, especially due to physical changes, and
in which he is more inclined to isolate himself from the social environment. They need
external approval and encouragement in the changes that occur with their physical and
mental developments. Even in healthy children, the lack of this approval and social
support may result in a negative development; Pediatric oncology patients are more
vulnerable due to the side effects of the disease and treatment process or the physical
and psychological effects it causes. For children whose psychosocial development
continues, being diagnosed with cancer causes an additional difficulty in their
developmental processes. Because children have less or inadequate coping mechanisms than
the average adult during this period; This may make it difficult to accept the disease
due to the negative effects of diagnosis and treatment.
This period, which is considered more vulnerable to trauma, makes the situation more
complicated and tiring for a pediatric oncology patient compared to an adult cancer
patient. For this reason, it is very important to control and manage the attitudes of
patients towards their own diseases. Minimizing psychosocial problems in order to get the
best benefit from the treatment process will also increase the patient's efficiency from
the treatment. In this study, it is aimed to evaluate the effect of the psychosocial
support videos provided by the community to pediatric oncology patients aged 10-18 on the
children's attitudes towards their own disease and treatment-related symptoms.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- In the 10-18 age group,
- Newly diagnosed with cancer (maximum three months ago),
- Ongoing active treatment,
- Speaking in Turkish,
- Having no visual, auditory, and mental problems,
- Knowing the diagnosis,
- Children who volunteer to participate in the research and their parents will be
included.
Exclusion Criteria:
- The hospitalization period is less than 4 weeks,
- Neutropenic children,
- In the terminal period,
- With intense pain expression,
- Being under any sedative/anticonvulsant/analgesic effect,
- Children and their parents who apply to the hospital with a life-threatening
illness/condition will not be included.
Gender:
All
Minimum age:
10 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Koc University
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Remziye Semerci, Assit. Prof.
Phone:
0 (535) 011 28 21
Email:
eumac14@ku.edu.tr
Start date:
February 1, 2023
Completion date:
September 11, 2023
Lead sponsor:
Agency:
Koç University
Agency class:
Other
Source:
Koç University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011278