NCT06357585

Brief Summary

Following and implementing innovations and current developments in care practices for children diagnosed with leukemia and their parents will allow the quality of care to increase. The purpose of this research is to evaluate the effect of web-based education given to parents of children diagnosed with leukemia on their knowledge level, satisfaction and self-efficacy. The research is a single-blind randomized controlled experimental research type. The research will be conducted in a single center, Ankara Bilkent City Hospital MH4 Children's Hospital Hematology-Oncology Clinics and Leukemia Polyclinic. The population of the research consists of parents of children diagnosed with leukemia between the ages of 2-18 who are followed and treated in the specified places. The sample of the research consists of 72 participants, 36 in the experimental group (the group that received web-supported training) and 36 in the control group (the group that continued routine treatment). The consent of the parents who meet the research criteria and voluntarily agree to participate in the study will be obtained with the "Informed Voluntary Consent Form" and the parents in both the experimental group and the control group will be given the "Child and Parent Introductory Information Form", "Child with Leukemia Parent Information Level Pre-Test Evaluation Form". ", "Generalized Perceived Self-Efficacy Scale" will be applied. Once the sufficient number is reached, web-based training will be provided to the parents in the experimental group. "Parents of Children with Leukemia Knowledge Level Post-Test Evaluation Form", "Generalized Perceived Self-Efficacy Scale" and "Web-Based Parents of Children with Leukemia Training Satisfaction Evaluation Form" will be applied to the parents who complete the training. No intervention will be made to the parents in the control group, and the children will continue their routine care and treatment process. The "Child with Leukemia Parent Knowledge Level Posttest Evaluation Form" and the "Generalized Perceived Self-Efficacy Scale" will also be applied to the parents in the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

June 7, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 4, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

leukemiachildnurses

Outcome Measures

Primary Outcomes (5)

  • Child with Leukemia Parent Knowledge Level Pre-Test Evaluation Form

    This form aims to evaluate the parents' knowledge levels before the training and the effectiveness of the training given in the post-training period. The form consists of "19" closed-ended questions about common symptoms in children with leukemia and the management of these symptoms. The evaluation form before the training (pre-test) and after the training (post-test) consists of the same questions. All of the items in questions 1, 2, 3, 6, 7, 8, 9, 11, 13, 14, 15, 16, 17, 18, 19 are correct, and questions 4, 5, 10 and 10 are correct. There is only one correct answer to question 12. Each of the items in questions 1, 2, 3, 6, 7, 8, 9, 11, 13, 14, 15, 16, 17, 18, 19 is worth 1 point, and "water and soap" in question 4 is worth 1 point. 5 points. The total knowledge score for the correct answers to the questions "once a week", 25,000 mm3 in the 10th question and "4-6 times" in the 12th question will be calculated as 1 point each.

    at the time before pre-education

  • Child with Leukemia Parent Knowledge Level Post-Test Evaluation Form

    This form aims to evaluate the parents' knowledge levels before the training and the effectiveness of the training given in the post-training period. The form consists of "19" closed-ended questions about common symptoms in children with leukemia and the management of these symptoms. The evaluation form before the training (pre-test) and after the training (post-test) consists of the same questions. All of the items in questions 1, 2, 3, 6, 7, 8, 9, 11, 13, 14, 15, 16, 17, 18, 19 are correct, and questions 4, 5, 10 and 10 are correct. There is only one correct answer to question 12. Each of the items in questions 1, 2, 3, 6, 7, 8, 9, 11, 13, 14, 15, 16, 17, 18, 19 is worth 1 point, and "water and soap" in question 4 is worth 1 point. 5 points. The total knowledge score for the correct answers to the questions "once a week", 25,000 mm3 in the 10th question and "4-6 times" in the 12th question will be calculated as 1 point each.

    within 15 days after education

  • Web-Based Child with Leukemia Parent Education Satisfaction Evaluation Form

    This form has been prepared to determine the objectives for the experimental class, the website provided for the training of the participants, and the training contents. There are "43" statements in the form, which include evaluation of the appearance of the website, its usability, the content of the website and the training provided on the website, and the level of usefulness. "18" expression in the form is prepared for the appearance and usability of the website, "12" expression is for the video explanations on the website, and "13" expression is for the modules on the website. The form was prepared according to the five-point Likert type (1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree). The lowest score from the form is "43" and the highest score is "215". A high score is considered to indicate that parents are satisfied with the education provided.

    within 15 days after education

  • Generalized Perceived Self-Efficacy Scale

    This scale aims to determine the amount of self-efficacy level of web-supported education given to children with leukemia. Scale items receive scores between 1 and 4, consist of positive items, and are evaluated based on the total score. Grading of the scale; Not true (1), somewhat true (2), more true (3), completely true (4). Total score is between 10-40. High score is considered as high self-efficacy perception.

    at the time before pre-education

  • Generalized Perceived Self-Efficacy Scale

    This scale aims to determine the amount of self-efficacy level of web-supported education given to children with leukemia. Scale items receive scores between 1 and 4, consist of positive items, and are evaluated based on the total score. Grading of the scale; Not true (1), somewhat true (2), more true (3), completely true (4). Total score is between 10-40. High score is considered as high self-efficacy perception.

    at the within 15 days after education

Study Arms (2)

web based education group

EXPERIMENTAL

Parents in the experimental group will be given web-based training for 5 weeks.

Other: Web based education

control group

EXPERIMENTAL

No intervention will be made to the parents in the control group, and the children will continue their routine care and treatment process.

Other: inactive group

Interventions

Web-based training will be provided to the parents in the experimental group regarding care practices for children diagnosed with leukemia.

web based education group

Parents in the control group will continue to receive routine care and treatment.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research,
  • Being 18 years or older,
  • Being directly responsible for the child's care,
  • Not having any physical or mental illness,
  • Being able to use a computer or mobile phone,
  • Having internet access and being able to use the internet,
  • Being open to communication,
  • Being literate,
  • Being able to speak and understand Turkish.

You may not qualify if:

  • Not following the site of membership,
  • Not having internet access and not being able to use the internet,
  • Being a foreign national,
  • Having vision or hearing problems,
  • Being illiterate,
  • To give up participating in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Keçiören, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • BURCU ÇALIK BAĞRIYANIK

    University of Health science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant blinding was done because the parents who participated in the study voluntarily did not know which group they were in until the end of the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Web-based training will be provided to parents in the experimental group, and parents in the control group will continue their routine treatment and care process.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

September 24, 2021

Primary Completion

December 8, 2022

Study Completion

March 24, 2024

Last Updated

June 7, 2024

Record last verified: 2024-04

Locations