The Effect of Different Animal Interventions on Procedural Pain and Anxiety Levels Due to Implantable Venous Port Catheter Needle Introduction in Patients Receiving Palliative Care: A Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study was conducted to examine the effect of parrot, fish, and turtle therapies on procedural pain and anxiety levels associated with implantable venous port catheter needle insertion in patients receiving palliative care.
详细描述
Pain and anxiety management are two symptoms that are quite challenging and important in cancer patients. Non-pharmacological methods are used alongside pharmacological methods to control pain and anxiety. This study was conducted to examine the effect of parrot, fish, and turtle therapies on procedural pain and anxiety levels associated with implantable venous port catheter needle insertion in patients receiving palliative care. The study was completed with a total of 120 individuals, including the parrot, fish, and turtle groups (n=30) and a control group. Before starting the study, all group participants completed a "Patient Information Form," and all participants in all groups completed the "Visual Analog Scale (VAS)" and "State-Trait Anxiety Inventory-I (STAI-I)" before (pre-test) and after (post-test) the implantable venous port catheter needle insertion. Patients in the experimental groups were provided with live parrots, fish, or turtles to spend time with during the needle insertion. No intervention was performed on patients in the control group other than needle insertion and data collection.There was a statistically significant difference (p<0.001) between the experimental groups and the control group in the mean scores of the total and subscale scores of the "VAS" and "STAI-I" after the port catheter needle insertion (post-test). no differences were found between the groups before port catheter needle insertion (pre-test) (p>0.05). Statistically significant differences were found between the mean scores of the total and subscale scores of the "VAS" and "STAI-I" for the experimental groups and the control group according to the measurement times within the groups (p<0.001). Parrot, fish, and turtle therapies were found to be effective in reducing pain and anxiety levels in cancer patients receiving palliative care. Parrot therapy was determined to be the most effective in reducing pain and anxiety.
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
Before the implantable port catheter needle insertion procedure began, a nurse academic (to prevent bias) who was unaware of the study details administered the "Structured Patient Information Form," "VAS," and "STAI-I" to the patients. After the implantable port catheter needle was inserted by another nurse, accompanied by a therapy animal (Sultan parrot, Betta fish, and Red-cheeked turtle) that provided interaction with the patients (such as watching and talking to the pet therapy animal), the "VAS" and "STAI-I" were administered again to measure patients' pain and anxiety levels during the procedure.
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
- •Being 18 years of age or older,
- •Agreement to participate in the study,
- •Being able to communicate verbally,
- •No vision, hearing, or speech problems,
- •The patient must have a port catheter,
- •The patient must be able to access the implantable port catheter needle in a single attempt,
排除标准
- •Refusal to participate in the study,
- •Resence of a psychiatric disorder,
- •Unstable general condition were determined as exclusion criteria.
研究组 & 干预措施
Sultan Parrot
Before the implantable port catheter needle insertion procedure began, a nurse academic (to prevent bias) who was unaware of the study details administered the "Structured Patient Information Form," "VAS," and "STAI-I" to the patients. After the implantable port catheter needle was inserted by another nurse, accompanied by Sultan parrot therapy that provided interaction with the patients (such as watching and talking to the pet therapy animal), the "VAS" and "STAI-I" were administered again to measure patients' pain and anxiety levels during the procedure.
干预措施: Sultan Parrot Therapy (Pet Therapy) (Behavioral)
Betta Fish
Before the implantable port catheter needle insertion procedure began, a nurse academic (to prevent bias) who was unaware of the study details administered the "Structured Patient Information Form," "VAS," and "STAI-I" to the patients. After the implantable port catheter needle was inserted by another nurse, accompanied by Betta fish therapy that provided interaction with the patients (such as watching and talking to the pet therapy animal), the "VAS" and "STAI-I" were administered again to measure patients' pain and anxiety levels during the procedure.
干预措施: Betta Fish Therapy (Pet Therapy) (Behavioral)
Red-Eared Slider Turtle Group
Before the implantable port catheter needle insertion procedure began, a nurse academic (to prevent bias) who was unaware of the study details administered the "Structured Patient Information Form," "VAS," and "STAI-I" to the patients. After the implantable port catheter needle was inserted by another nurse, accompanied by Red-cheeked turtle therapy that provided interaction with the patients (such as watching and talking to the pet therapy animal), the "VAS" and "STAI-I" were administered again to measure patients' pain and anxiety levels during the procedure.
干预措施: Red-Eared Slider Turtle Therapy (Pet Therapy) (Behavioral)
Control Group
No procedures other than the needle insertion procedure for implantable port catheters were performed on these patients. Before and after the implantable port catheter needle insertion procedure, a nurse academic (to prevent bias) who was unaware of the details of the study administered the "Structured Patient Information Form," "VAS," and "STAI-I".
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Day 1
The scale developed by Price et al. measures the intensity of pain in patients. The VAS, used to measure the intensity of the patient's pain perception, is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of the pain they feel. The marked numerical value indicates the intensity of the patient's pain perception. VAS value of 1-4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. "VAS" were administered to the patients 2 times in total before the study (pretest) and the end of the end of the survey (posttest).
State-Trait Anxiety Inventory-I (STAI-I)
时间窗: Day 1
Developed by Spielberger et al., the STAI-I is a 20-item self-report scale that measures momentary anxiety levels . The validity and reliability study of the Turkish adaptation of the scale was conducted by Öner and Lecompte . Participants respond according to a four-point scale ranging from "Never" (1) to "Completely" (4). In the scale, 10 items are directly coded (3, 4, 6, 7, 9, 12, 13, 14, 17, 18) are positive, while 10 items are reverse-coded (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) and are negative. The scoring of reverse items is reversed (1→4, 4→1). All scores are added together, and 50 is added to the raw score to calculate a total score between 20 and 80. A score of 21-40 on the scale is considered mild anxiety, 41-60 is moderate anxiety, and 61 and above is severe anxiety "STAI-I" were administered to the patients 2 times in total before the study (pretest) and the end of the end of the survey (posttest).
次要结局
未报告次要终点
研究者
Hatice Demirağ, Ph.D
Assistant professor
Karadeniz Technical University