The Effect of Z Technique Treatment on Comfort, Pain and Undesirable Symptoms in Allergy Patients Receiving Immunotherapy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1.VAS Scale:
研究概览
简要总结
An allergy is an abnormal response of the immune system to a generally harmless antigen. Pollens in the air play an important role in the formation of respiratory allergies and can be a trigger for the development of allergies (Won, 2022). By providing relaxation by nurses and taking measures to ensure the continuity of relaxation; Maintaining the well-being of the individual, family or society is possible with the comfort theory (Kolcaba and Kolcaba, 1991; Kolcaba, 1994). Although subcutaneous immunotherapy is performed in the presence of specialist physicians and trained nurses, some local side effects may develop after injection. One of the local side effects is pain, swelling and redness at the injection site (Arslan and Caliskaner, 2022).
The aim of this study; The aim of this study is to determine the effect of the treatment with the Z technique on allergy patients receiving immunotherapy on comfort, pain and adverse symptoms using a randomized controlled experimental method.
The hypotheses of the study H0: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy has no effect on comfort levels, pain and adverse symptoms H1: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Comfort Levels H2: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Pain Levels H3: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Undesirable Symptoms
详细描述
An allergy is an abnormal response of the immune system to a generally harmless antigen. Pollens in the air play an important role in the formation of respiratory allergies and can be a trigger for the development of allergies (Won, 2022). By providing relaxation by nurses and taking measures to ensure the continuity of relaxation; Maintaining the well-being of the individual, family or society is possible with the comfort theory (Kolcaba and Kolcaba, 1991; Kolcaba, 1994). Although subcutaneous immunotherapy is performed in the presence of specialist physicians and trained nurses, some local side effects may develop after injection. One of the local side effects is pain, swelling and redness at the injection site (Arslan and Caliskaner, 2022).
The aim of this study; The aim of this study is to determine the effect of the treatment with the Z technique on allergy patients receiving immunotherapy on comfort, pain and adverse symptoms using a randomized controlled experimental method.
The hypotheses of the study H0: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy has no effect on comfort levels, pain and adverse symptoms H1: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Comfort Levels H2: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Pain Levels H3: Treatment with Z Technique for Allergy Patients Receiving Immunotherapy Has an Effect on Undesirable Symptoms The research is a pre-post-test two-group randomized controlled study in experimental design.
The research population consists of 104 patients who received allergy treatment in Kocaeli Derince Training and Research Hospital in the last year. In this study, "G. In the calculation made using the "Power-3.1.9.2" program and using a similar study at the sample level at 80% confidence level (yilmaz et al., 2016), a total of 60 individuals, 30 of which were experimental and 30 of which were control, was determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants were divided into groups using the "simple randomization method". Participants were not informed about which group they belonged to. Automated computer-based randomization resulted in the execution of the experiment with the timing scenario and the confidential assignment of participants to one of the 2 intervention arms. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or control condition. Additionally, researchers who code and analyze data will be blind to randomization and interference.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be receiving immunotherapy treatment at Kocaeli Derince Training and Research Hospital, be between the ages of 18-65, Volunteering to participate in the research,
排除标准
- •Not wanting to participate in the research voluntarily The state of moving the individual to a different country for any reason The end of the immunotherapy treatment period
结局指标
主要结局
1.VAS Scale:
时间窗: three months
It is a scale numbered from 1 to 10 to measure the severity of pain that may occur after immunotherapy. Individuals rank 10 points for pain they feel most intensely and 1 point for pain they feel least severe.
2.General Comfort Scale:
时间窗: three months
Comfort Theory was developed by Katharina Kolcaba in 1990. The sub-dimensions of the General Comfort Scale, which was validated and reliable in Turkish by Çıtlık Sarıtaş et al. in 2018, were defined as relief (9 items), relaxation (9 items), and overcoming problems (10 items). The lowest possible value, 1, indicates low comfort, and the highest value, 6, indicates high comfort.
3. Undesirable Symptoms Tracking Form:
时间窗: three months
It is a form we developed to evaluate swelling, redness and leakage of the drug after 1 hour and 1 day after immunotherapy. Undesirable Symptoms Follow-up Form will be prepared and applied to the individuals participating in the study.
次要结局
未报告次要终点
研究者
Gönül GÖKÇAY
Asist. Prof.
Kafkas University