Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT07162558
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients
Sponsor:
Near East University, Turkey
Organization:
Study Overview
Official Title:
The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
lifestyle
Brief Summary:
This randomized clinical trial aimed to evaluate the effectiveness of a child-centered empowerment model in improving the lifestyle of children with leukemia. The study focused on whether structured empowerment interventions could significantly enhance daily habits and overall well-being in pediatric oncology patients. The main research questions were:
Does the child-centered empowerment model improve the lifestyle of children with leukemia? Can this complementary and non-invasive method be considered a viable approach for supporting pediatric care?
Participants (N = 46) aged 7-13 years were randomly assigned to either the intervention group, which received empowerment training in four dimensions (perceived threat, self-efficacy, educational participation, and evaluation), or the control group, which received routine care. Pre- and post-intervention assessments were conducted using a validated lifestyle questionnaire measuring nutrition, sleep, physical activity, physical health, and stress.
Does the child-centered empowerment model improve the lifestyle of children with leukemia? Can this complementary and non-invasive method be considered a viable approach for supporting pediatric care?
Participants (N = 46) aged 7-13 years were randomly assigned to either the intervention group, which received empowerment training in four dimensions (perceived threat, self-efficacy, educational participation, and evaluation), or the control group, which received routine care. Pre- and post-intervention assessments were conducted using a validated lifestyle questionnaire measuring nutrition, sleep, physical activity, physical health, and stress.
Detailed Description:
Study Title:
The Effect of Child-Centered Empowerment on the Lifestyle of Children with Leukemia
Study Purpose:
The aim of this study was to investigate the efficacy of a child-centered empowerment model in improving the lifestyle of pediatric patients with leukemia. The intervention was designed to strengthen coping abilities, promote healthier daily habits, and enhance overall well-being, in line with holistic and family-centered nursing principles. The study was conducted as a double-blind randomized clinical trial.
Sample Size Determination:
The statistical population of this study included school-aged children (7-13 years) diagnosed with leukemia and admitted to a pediatric oncology clinic in Tehran. A total of 46 eligible children who met the inclusion criteria were enrolled using purposive sampling. Participants were randomly assigned into experimental (n = 23) and control groups (n = 23).
Sample size was determined using the mean comparison formula based on a similar study (Shoghi et al., 2019), with Type I error set at 0.05 and power at 80%. The required sample size was calculated as 19 per group, which was increased to 23 per group to account for an anticipated 20% dropout rate.
To minimize bias, a double-blind design was used. The researcher responsible for data collection was unaware of group allocations, and the statistician analyzing the data processed them under masked labels (x1 and x2).
Tools of Data Collection:
A) Demographic questionnaire: Collected background information including age, gender, weight, height, knowledge of illness, and place of living.
B) Lifestyle questionnaire: A validated 38-item tool assessing five domains-nutrition, sleep, physical activity, physical health, and stress. Each item was rated on a 4-point Likert scale ("often" to "never"), with total scores ranging from 38 to 114, categorized as unfavorable (38-63), average (64-88), and favorable (89-114). Validity and reliability were confirmed in prior studies (Farahani et al., 2018).
C) Pre- and post-intervention lifestyle assessment: Completed by all participants before and one month after the intervention period.
Intervention:
Experimental Group:
Children and their families participated in a structured child-centered empowerment program consisting of five sessions (30 minutes each) delivered by a trained pediatric nursing expert. The intervention included four dimensions:
Perceived Threat: Increasing awareness of the illness, complications, and treatment process through group discussions.
Self-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief and self-control.
Educational Participation: Children were provided with educational cards to share learned content with family members, reinforcing knowledge and responsibility.
Evaluation: Ongoing assessment of understanding and active involvement through follow-up questions after each session.
Instructional materials were also shared via social media (WhatsApp) to enhance family engagement.
Control Group:
Children in the control group received routine care only, with no empowerment training.
Implementation Phase:
The study was conducted in the pediatric oncology clinic in Tehran. After recruitment, children were randomly allocated into intervention or control groups based on admission order (even-numbered admissions to intervention, odd-numbered to control). All participants completed demographic and lifestyle questionnaires before the intervention, and lifestyle reassessment was conducted one month after program completion.
Ethics approval The research received ethical clearance from the Near East University Ethics Review Board with the approval number NUE/2023/117-1776. The initiative closely followed the ethical standards established by the Council of Ethics and was carried out in complete accordance with the principles outlined in the Declaration of Helsinki (1964).
Statistical Analysis:
All data were analyzed using SPSS version 25. The Kolmogorov-Smirnov test was applied to check data normality. Descriptive statistics (mean, standard deviation, and frequencies) were used for demographic data. Inferential statistics included:
Paired t-test to compare pre- and post-intervention scores within each group Independent t-test to compare differences between experimental and control groups Chi-square test to analyze categorical variables A significance level of P \< 0.05 was considered statistically significant.
The Effect of Child-Centered Empowerment on the Lifestyle of Children with Leukemia
Study Purpose:
The aim of this study was to investigate the efficacy of a child-centered empowerment model in improving the lifestyle of pediatric patients with leukemia. The intervention was designed to strengthen coping abilities, promote healthier daily habits, and enhance overall well-being, in line with holistic and family-centered nursing principles. The study was conducted as a double-blind randomized clinical trial.
Sample Size Determination:
The statistical population of this study included school-aged children (7-13 years) diagnosed with leukemia and admitted to a pediatric oncology clinic in Tehran. A total of 46 eligible children who met the inclusion criteria were enrolled using purposive sampling. Participants were randomly assigned into experimental (n = 23) and control groups (n = 23).
Sample size was determined using the mean comparison formula based on a similar study (Shoghi et al., 2019), with Type I error set at 0.05 and power at 80%. The required sample size was calculated as 19 per group, which was increased to 23 per group to account for an anticipated 20% dropout rate.
To minimize bias, a double-blind design was used. The researcher responsible for data collection was unaware of group allocations, and the statistician analyzing the data processed them under masked labels (x1 and x2).
Tools of Data Collection:
A) Demographic questionnaire: Collected background information including age, gender, weight, height, knowledge of illness, and place of living.
B) Lifestyle questionnaire: A validated 38-item tool assessing five domains-nutrition, sleep, physical activity, physical health, and stress. Each item was rated on a 4-point Likert scale ("often" to "never"), with total scores ranging from 38 to 114, categorized as unfavorable (38-63), average (64-88), and favorable (89-114). Validity and reliability were confirmed in prior studies (Farahani et al., 2018).
C) Pre- and post-intervention lifestyle assessment: Completed by all participants before and one month after the intervention period.
Intervention:
Experimental Group:
Children and their families participated in a structured child-centered empowerment program consisting of five sessions (30 minutes each) delivered by a trained pediatric nursing expert. The intervention included four dimensions:
Perceived Threat: Increasing awareness of the illness, complications, and treatment process through group discussions.
Self-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief and self-control.
Educational Participation: Children were provided with educational cards to share learned content with family members, reinforcing knowledge and responsibility.
Evaluation: Ongoing assessment of understanding and active involvement through follow-up questions after each session.
Instructional materials were also shared via social media (WhatsApp) to enhance family engagement.
Control Group:
Children in the control group received routine care only, with no empowerment training.
Implementation Phase:
The study was conducted in the pediatric oncology clinic in Tehran. After recruitment, children were randomly allocated into intervention or control groups based on admission order (even-numbered admissions to intervention, odd-numbered to control). All participants completed demographic and lifestyle questionnaires before the intervention, and lifestyle reassessment was conducted one month after program completion.
Ethics approval The research received ethical clearance from the Near East University Ethics Review Board with the approval number NUE/2023/117-1776. The initiative closely followed the ethical standards established by the Council of Ethics and was carried out in complete accordance with the principles outlined in the Declaration of Helsinki (1964).
Statistical Analysis:
All data were analyzed using SPSS version 25. The Kolmogorov-Smirnov test was applied to check data normality. Descriptive statistics (mean, standard deviation, and frequencies) were used for demographic data. Inferential statistics included:
Paired t-test to compare pre- and post-intervention scores within each group Independent t-test to compare differences between experimental and control groups Chi-square test to analyze categorical variables A significance level of P \< 0.05 was considered statistically significant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: