The Effect of Community-Provided Psychosocial Support Videos on Disease Attitudes and Symptoms

NCT06011278 | Unknown

• 1 other identifier: EysanU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Chıld Attıtude Toward Illness Scale

  It was developed to measure the attitudes of children with chronic diseases towards their own diseases. During the evaluation, the scores obtained from 13 items are added and divided into 13 or according to the number of items.The total score range is 1 to 5. A score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, and 4 and 5 indicates positive attitude.

  Three week

Secondary Outcomes (1)

• Memorial Symptom Assessment Scale

  Three week

Study Arms (2)

Community-supported videos

EXPERIMENTAL

Community-supported videos will be sent to the children in the experimental group once a week for a month. At the end of four weeks, the "Chıld Attıtude Toward Illness Scale" and the "Memorial Symptom Assessment Scale" will be administered to the children again.

Other: Community Supported Videos

Standard care

NO INTERVENTION

Children in the control group will receive the standard care of the pediatric oncology clinic.At the end of four weeks, the "Chıld Attıtude Toward Illness Scale" and the "Memorial Symptom Assessment Scale" will be administered to the children again.

Interventions

Community Supported Videos OTHER

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.

Community-supported videos

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Zeytinburnu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Eyşan Umaç, MsC

  Koç University

  STUDY CHAIR

Central Study Contacts

Eyşan Hanzade Umaç

CONTACT

5068418841; eumac14@ku.edu.tr

Remziye Semerci, Assit.Prof.

CONTACT

0 (535) 011 28 21; rsemerci@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assisstant

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: February 1, 2023
• Primary Completion: September 8, 2023
• Study Completion: September 11, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)