The Effect of Pranic Healing Based on Rogers' Therapeutic Touch Nursing Theory on Cardiorespiratory Indices and Pain Related to Venipuncture in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Pain Levels During Venipuncture
研究概览
简要总结
The goal of this clinical trial is to evaluate whether Pranic healing, based on Rogers' therapeutic touch nursing theory, can reduce pain and improve cardiorespiratory indices during venipuncture in children. The main questions it aims to answer are:
Does Pranic healing reduce the pain experienced by children during venipuncture? How does Pranic healing affect cardiorespiratory indices, such as heart rate, respiratory rate, and arterial oxygen saturation, during and after venipuncture?
Researchers will compare the effects of Pranic healing to routine care (without Pranic healing) to determine its effectiveness.
Participants will:
Receive Pranic healing or routine care before, during, and after venipuncture Have their pain levels, heart rate, respiratory rate, and arterial oxygen saturation measured Be randomly assigned to either the intervention group (Pranic healing) or the control group (routine care) Have their pain and physiological responses monitored and recorded during the procedure
详细描述
Study Title: The Effect of Pranic Healing Based on Rogers' Therapeutic Touch Nursing Theory on Cardiorespiratory Indices and Pain Related to Venipuncture in Children: A Double-Blind Randomized Clinical Trial Study Purpose:This study will investigate the efficacy of Pranic healing, informed by Rogers' therapeutic touch nursing theory, in mitigating pain and enhancing cardiorespiratory indices in children undergoing venipuncture. The double-blind, randomized clinical trial will be conducted in the pediatric ward of Near East University Hospital, Northern Cyprus.
Study Subjects: Sample Size: 46 school-aged children, aged 6 to 12 years. Sampling Method:Convenience sampling followed by random block sampling. Groups: Experimental group (Pranic healing) and control group.
Sample size determination:
The statistical population of this research includes school-aged children admitted to one hospital in Northern Cyprus.
After obtaining consent, the children were randomly will be divided into the experimental and control groups. Then, a control and experimental group of 23 people will be formed by random block sampling method. In this method, blocks are formed based on the variables in question, and half of the intervention people and half of the control people are included in each block, the main goal in this method is to balance the number of participants in each of the groups. The four block randomization method will be used and the patients will be placed in experimental group groups (A) and control group (B), so that first 12 blocks of four and one block of two were prepared as follows: AABB, ABAB , ABBA, BBAA, BABA, BAAB, ABAB, AABB, BBAA, BAAB, BABA, ABBA, AB And then people will be assigned to two groups based on the list prepared in terms of A and B; This work is continuously repeated until the sample size is completed.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
To minimize biased information, we employed a double-blind approach. The data will be collected by the researcher, and the statistician will be unaware of the groups; data will be analysed as variables x1 and x2.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12 years experiencing pain during venipuncture
- •Willingness of the child and family to cooperate and participate in the research
- •No specific mental disorder as reported by the parents
- •Not having taken acetaminophen or any other painkillers the night before
排除标准
- •Severe restlessness of the child
- •Lack of consent from the mother to continue participating in the study
结局指标
主要结局
Pain Levels During Venipuncture
时间窗: Pain levels will be measured at three time points: 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.
The primary outcome measure will assess changes in pain levels experienced by children during venipuncture. Pain will be evaluated using the Wong-Baker FACES Pain Rating Scale, which is a validated tool for measuring pain in pediatric patients. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with 0 indicating "no pain" and 10 indicating "the worst pain possible." Higher scores represent worse pain outcomes.
次要结局
- Changes in Arterial Oxygen Saturation(Arterial oxygen saturation will be recorded at 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.)
- Changes in Respiratory Rate(Respiratory rate will be measured 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.)
- Changes in Pulse Rate(Pulse rate will be recorded at 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.)
研究者
Pouran Varvani Farahani
PhD student in Pediatric Nursing, Near East University , Faculty of Nursing
Near East University, Turkey