Effect of Humor on Pain and Anxiety in Patients With Rheumatoid Arthritis: A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this prospective, randomized controlled study was to inverstigate the effect of humor on pain and in patients with rheumatoid arthritis (RA) during IV treatment. The main question[s] it aims to answer are:
- to compare the effect of humor on pain between two groups of patients with RA who watched a comedy movie (intervention group) and who did not (control group) during IV biological therapy.
- to compare the effect of humor on anxiety between two groups of patients with RA who watched a comedy movie (intervention group) and who did not (control group) during IV biological therapy.
Participants in the intervention group watched a comedy movie during routine IV biologic treatment in the chemotherapy unit, while the control group received only routine IV biologic treatment as a usual care.
详细描述
Settings and Participants This study included a total of 36 patients who were diagnosed with RA according to the criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) (Aletaha et al. 2010) and received IV biological drug therapy in the chemotherapy day unit of an oncology clinic between September 2020 and November 2021. In addition to hematological and oncological patients receiving outpatient chemotherapy, patients receiving outpatient IV/subcutaneous biologic drug therapy were also treated in the chemotherapy day unit. As a result of the posterior power analysis, the power was calculated as 1.00 (100%) for the VAS with n=36. The patients were randomized allocated two groups: Intervention group and control group. Both groups received routine IV biologic treatment.The allocation ratio was set 1:1.
Inclusion criteria The following study inclusion criteria were used: having reached the age of 18; having been given a diagnosis of RA in accordance with the ACR/EULAR (9) classification criteria at least six months prior to the study; receiving IV biologic infusion therapy in the chemotherapy day unit; not having any other inflammatory diseases; experiencing pain that ranged from 4 to 8 on the VAS; not having been given a complex disease, such as cancer; not being pregnant; and having no mental diagnosis, no drug use-related or disease-related impairment of consciousness, no communication issue, and voluntary participation in the study.
Exclusion criteria The exclusion criteria were the following: a switch in treatment method during the intervention or any discomfort such as dizziness or nausea while watching a comic film.
Outcomes were assessed as pre-post test immediately before and after the IV biologic infusion treatment:
- Pre-test: Before the IV infusion treatment, the patients were evaluated face-to-face by the researcher in an empty quiet examination room in the chemotherapy day unit using a descriptive information form, the Visual Analog Scale (VAS), and the State-Trait Anxiety Inventory (STAI).
- Post-test: After the IV infusion treatment (post-test), the patients were re-evaluated using the VAS and the SAI.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having reached the age of 18; having been given a diagnosis of RA in accordance with the ACR/EULAR (Aletaha et al. 2010) classification criteria at least six months prior to the study; receiving IV biologic infusion therapy in the chemotherapy day unit; not having any other inflammatory diseases; experiencing pain that ranged from 4 to 8 on the VAS; not having been given a complex disease, such as cancer; not being pregnant; and having no mental diagnosis, no drug use-related or disease-related impairment of consciousness, no communication issue, and voluntary participation in the study.
排除标准
- •a switch in treatment method during the intervention or any discomfort such as dizzi-ness or nausea while watching a comic film.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: VAS score will evaluate direct after the IV biologic infusion treatment
VAS is the pain rating scale. A VAS consists of a line, often 10 cm long, with verbal anchors at either end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
次要结局
- State-Trait Anxiety Inventory (STAI)(STAI scores will evaluate direkt after the IV biologic infusion treatment.)
研究者
Güler Balci Alparslan
Prof. Dr.
Eskisehir Osmangazi University