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临床试验/NCT05191641
NCT05191641招募中不适用

Evaluation of the Effect of Individualized Nursing Care Based on the Professional Values Model for Parents of Pediatric Oncology Patients: A Randomized Controlled Trial

Akdeniz University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Individual values awareness level

研究概览

简要总结

Objective: This study was planned to evaluate the effectiveness of individualized nursing care based on the Professional Values Model for parents of pediatric oncology patients.

Method: Simple randomization will be used to evaluate the intervention and control groups. The sample of the study will be the parents of children aged 1-18 years (Intervention group: 35 parents, Control group: 35 parents) diagnosed with cancer in the Akdeniz University Hospital Pediatrics, Hematology and Oncology clinic and hospitalized. Portrait Values Questionnaire and PedsQL Health Care Satisfaction Hematology/Oncology Module Parent Form will be used to collect data. A 12-week individualized nursing care based on the Professional Values Model will be applied to 35 parents in the intervention group. The effectiveness of the program will be evaluated after all post-test applications are completed.

详细描述

Study Design: A single-blind, randomized controlled trial

Participants and Setting: The population of the research will be the parents of the children hospitalized in the Pediatrics, Hematology and Oncology Clinic of Akdeniz University Hospital. Parents who agreed to participate in the research (Intervention group: 35 parents, Control group: 35 parents) will form the sample of the research. Simple randomization will be used to evaluate the intervention and control groups.

Randomization, allocation, and blinding: After obtaining informed consent from the parents, each will be given a unique sequence number in a sealed envelope. In this study, random selection of participants and assignment to groups will be done by a nurse at the clinic where the research was conducted. Thus, the researcher who implements the training will be blinded. The Consolidated Reporting Standards (CONSORT) flowchart (Moher et al., 2012) will be followed to manage the random allocation process. The 12-week individualized nursing care practice will be carried out by a nurse with sufficient communication skills, 11 years of pediatric oncology clinical and responsible nursing experience, and a doctoral degree in pediatric nursing in the study team. Thus, the difference that may arise from the educator will be eliminated. Depending on the nature of the intervention administered, researchers and participants will not be blinded. The data will be analyzed by the statistician who is unaware of the intervention and control groups. Thus, it will be possible to be blind in terms of statistics and reporting.

Instruments: Parent Descriptive Information Form, Portrait Values Questionnaire (PVQ) and Pediatric Quality of Life Inventory (PedsQL) Health Care Satisfaction Hematology/Oncology Module Parents Form will be used to collect data. Parent Descriptive Information Form was created by the researchers in order to determine the socio-demographic characteristics of the sample. Form consists of a total of 15 items. PVQ is a 40-item scale developed by Schwartz et al. (2001) to measure individuals' value orientations more effectively. Participants were asked to mark how similar the items were to themselves with a 6-level rating. The scale consists of 40 items and 10 sub-dimensions. The sub-dimensions are described as follows. Turkish validity and reliability was established (Demirutku & Sümer, 2010). PedsQL was developed by James Varni et al. in 2000 and adapted into Turkish in 2012 by Kürtüncü Tanır and Kuğuoğlu. PedsQL; 1) general satisfaction (3 items), 2) knowledge (5 items), 3) family involvement (4 items), 4) communication (5 items), 5) technical skills (4 items), 6) emotional needs (4 items) It is a versatile inventory consisting of 25 items. The inventory has only the parent form. In the inventory prepared according to the five-point Likert system, it is expressed as I am not satisfied (1), I am not satisfied (2), I am undecided (3), I am satisfied (4) and I am very satisfied (5).

Data collection: The data will be collected in a time period that will not disrupt the care practices of the sick child, at the place and time deemed appropriate by the clinical nurse and the parent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The statistician will be blind in evaluating the results. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Scales will be evaluated by the researcher who cannot be blinded due to the nature of the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being the parent of a pediatric oncology patient
  • Speak and understand Turkish

排除标准

  • 未提供

结局指标

主要结局

Individual values awareness level

时间窗: Individual values awareness level of parent will be evaluated 3 times: pre-test, 1 week after the pre-test, and 12 weeks after the pre-test. The increase in both the mid-term and post-test scores in the 12-week period is the outcome measure.

An increase in parents' awareness of their individual values is a measure of outcome. This increase will be measured by the "Portrait Values Questionnaire". The higher the average score, the higher the awareness of individual values. Statistical significance will be set at p \< 0.05. One week after the "pre-test" for the intervention group, an "intermediate evaluation" will be made with the same measurement tool. In the interim evaluation, it will be evaluated whether there is an increase according to the pre-test score. 12 weeks after the "Portrait Values Questionnaire" and the "pretest", the same group will be given a "posttest" with the same measurement tool. In the post-test, it will be evaluated whether there is an increase in the mid-test and pre-test scores. If there is an increase in both "interim evaluation" and "post-test" scores compared to the "pretest" scores, it can be stated that the training program is effective on individual values.

Parent satisfaction level

时间窗: Parent satisfaction level will be evaluated 3 times: pre-test, 1 week after the pre-test, and 12 weeks after the pre-test. The increase in both the mid-term and post-test scores in the 12-week period is the outcome measure.

The increase in the level of awareness of the satisfaction level of the parents is a measure of outcome. This increase will be measured by the "Pediatric Quality of Life Inventory Health Care Satisfaction Hematology/Oncology Module Parents Form". The higher the average score, the higher the parent satisfaction. Statistical significance will be set at p \< 0.05. One week after the "pre-test" for the intervention group, an "intermediate evaluation" will be made with the same measurement tool. In the interim evaluation, it will be evaluated whether there is an increase according to the pre-test score. 12 weeks after the "pretest", the same group will be given a "posttest". In the post-test, it will be evaluated whether there is an increase in the mid-test and pre-test scores. If there is an increase in both "interim evaluation" and "post-test" scores compared to the "pretest" scores, it can be stated that the training program is effective on parent satisfaction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayla Kaya

Research Assistant Dr.

Akdeniz University

研究点 (2)

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