Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care

NCT ID: NCT05457153

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-30

Brief Summary

Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".

Detailed Description

Hypothesis:

H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.

H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.

H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.

Conditions

Childhood Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Technology-Based Well-Being Process Program

WEBEPROP will be conducted for 8 weeks. The program for the intervention group is included the modüls. In the program, the modules of "Self-Knowledge, Inner Communication and Awareness of Perceptions, Emotion and Thought Management" will be completed in 8 weeks (each model two weeks) . The other module will not be accessible and cannot be switched before the prevous module is completed.

Group Type: EXPERIMENTAL

Well-Being Process Program (WEBEPROP)

Intervention Type: OTHER

Technology-Based Well-Being Process Program (WEBEPROP)

Control Group

After the first follow-ups have been made to the control group, they will continue to receive standard care. After the monitoring of the initiative group within the scope of the program is completed, the website of the well-being process program will be made available to the control group. Children and adolescents will benefit from the modules by promoting the website.

Group Type: ACTIVE_COMPARATOR

Well-Being Process Program (WEBEPROP)

Intervention Type: OTHER

Technology-Based Well-Being Process Program (WEBEPROP)

Interventions

Well-Being Process Program (WEBEPROP)

Technology-Based Well-Being Process Program (WEBEPROP)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 10-20,
• Child and adolescent with palliative care needs
• At least 3 months before diagnosis
• Child and adoescent have completed the induction phase of treatment,
• İntermediate-high-risk group defined under a treatment protocol,
• Child and aolescent can utilizecomputer, mobile phone and tablet
• Children and adolescents who agreed to participate in the survey and their parent.

Exclusion Criteria

• Newly diagnosed with physical and mental disabilities,
• Child and adolescent with severe anxiety according to the anxiety score scale,
• Out of diagnosis in the last 6 months (loss of parents, natural disaster, etc.) are children and adolescents who experience high levels of stress and have an important psychiatric diagnosis that affects their mental health.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Kilicarslan Toruner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sümeyye YILDIZ, PhD Student

Role: CONTACT

sumeyye.yildiz1@gazi.edu.tr

0534 682 37 94

Ebru KILIÇARSLAN TORUNER,, PhD, RN

Role: CONTACT

ebrutoruner@gazi.edu.tr

Other Identifiers

2021 - 846

Identifier Type: -

Identifier Source: org_study_id