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临床试验/NCT07241780
NCT07241780已完成不适用

The Effect of Live and Non-Living Parrot Therapy on Pain During Venous Blood Collection in Individuals With Chronic Diseases: A Double-Blind Randomized Controlled Study

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年7月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

This double-blind randomized controlled trial was conducted to comparatively evaluate the effectiveness of live parrot, robotic parrot, and parrot picture therapies on pain during venipuncture in adults with chronic illness.

详细描述

Although venipuncture is a routine part of diagnostic and treatment processes, it is an invasive procedure that causes significant pain, anxiety, and physiological stress responses in individuals. This negative experience becomes a health problem, reduces treatment compliance, and can negatively affect quality of life, especially in individuals with chronic diseases such as diabetes and chronic kidney failure, who require regular follow-up and treatment. The systemic side effects and practical limitations of pharmacological pain control methods increase the need for safe, effective, and easy-to-apply non-pharmacological methods every day. In this context, distraction stands out as one of the most widely accepted mechanisms for modulating pain.

In the literature, the effect of non-pharmacological treatment methods reported to reduce pain and suffering is mostly explained by the gate control theory. According to the Gate Control Theory, the activity of thin and thick fibers located in the dorsal horn of the spinal cord acts as a gate that controls the sensation of pain. The activity of thin fibers opens this gate, while the activity of thick fibers closes it. When the gate is open, the pain signal reaches the conscious level, while when it is closed, the signal is prevented from reaching the conscious level. Therefore, by ensuring that patients receive intense stimulation through distraction methods such as pet therapy, the passage of pain signals to the brain stem is inhibited, and the patient's perception of pain is prevented.

In the pediatric population, parent-involved distraction and blowing a pinwheel, light-up toys, kaleidoscopes, blowing balloons, play dough, and watching cartoonshave been shown to significantly reduce pain. In adults, the Valsalva maneuver, the cough trick, music therapy, acupressure, and virtual reality have been reported to yield similarly positive results.

Animal-assisted therapies are gaining attention as a powerful non-pharmacological option in emotional and attentional contexts. In one study in children with type 1 diabetes found that interaction with a live animal was effective in reducing the pain of insulin injections. However, the use of live animals has significant limitations, such as infection control, allergy risk, animal welfare, the need for trained personnel, and cost. These limitations necessitate the exploration of alternative and more practical models. While robotic animals have the potential to overcome some of these challenges by offering realistic appearance and interaction, simple images can be considered a cost-free and universally applicable option. Parrots, in particular, are an attractive therapeutic tool in both live and robotic forms due to their colorful feathers, social nature, and mimicry skills. Indeed, the literature shows that even the use of animal-themed tubes or images can reduce pain and fear in children. However, no double-blind randomized controlled study has been found that directly compares the relative effectiveness of a live parrot, an advanced interactive robotic parrot, and a static parrot image in managing venipuncture pain in adults with chronic illness. This study was conducted to evaluate the effect of pet therapy (live parrot, robotic parrot, parrot image) applied using the three different attention-distraction methods mentioned above on venipuncture pain in individuals with chronic illnesses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Care Provider, Investigator)

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

  • •Individuals aged 18 years or older,
  • •Literate,
  • •Able to communicate verbally,
  • •Without vision/hearing/speech problems,
  • •With at least 6 months of chronic disease,
  • •With a single venous access point, and who gave consent were included.

排除标准

  • •Refusal to give consent,
  • •Psychiatric diagnosis,
  • •Hemodynamic instability,
  • •Presence of Chronic Obstructive Pulmonary Disease/Asthma,
  • •Chronic disease duration of less than 6 months.

研究组 & 干预措施

Live Parrot Group

Experimental

Before the venipuncture procedure began in the venipuncture unit, a nurse who was unaware of the details of the study (to prevent bias) administered the "Structured Patient Information Form" and "Visual Analogue Scale" to the patients. After the patient's venous blood was drawn by another nurse, the "Visual Analogue Scale " was administered again to measure the patients' pain levels during venipuncture.

干预措施: Live Parrot therapy (Pet therapy) (Other)

Robotic Parrot Group

Experimental

Before the venipuncture procedure began in the venipuncture unit, a nurse who was unaware of the details of the study (to prevent bias) administered the "Structured Patient Information Form" and "Visual Analogue Scale" to the patients. After the patient's venous blood was drawn by another nurse, the "Visual Analogue Scale " was administered again to measure the patients' pain levels during venipuncture.

干预措施: Robotic Parrot therapy (Pet therapy) (Other)

Picture Parrot Group

Experimental

Before the venipuncture procedure began in the venipuncture unit, a nurse who was unaware of the details of the study (to prevent bias) administered the "Structured Patient Information Form" and "Visual Analogue Scale" to the patients. After the patient's venous blood was drawn by another nurse, the "Visual Analogue Scale " was administered again to measure the patients' pain levels during venipuncture.

干预措施: Picture Parrot therapy (Pet therapy) (Other)

Control Group

No Intervention

Before the venipuncture procedure began in the venipuncture unit, a nurse (to prevent bias) who was unaware of the study details administered the "Structured Patient Information Form" and the "Visual Analogue Scale" to the patients. After the patient's venous blood was collected by another nurse, the "Visual Analogue Scale" was administered again to measure the patients' pain levels during venipuncture. No other procedures were performed on these patients besides venipuncture.

结局指标

主要结局

Visual Analogue Scale

时间窗: Day 1

The visual analogue scale is used to assess the intensity of pain experienced by individuals during acute pain. The scale consists of a vertical or horizontal line measuring 10 centimeter/100 millimeter in length, ranging from 0 points = no pain to 10 points = unbearable pain. In this project, it was used twice on each participant to determine their pain level before and during venipuncture.

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

Hatice Demirağ, Ph.D

Assistant professor

Karadeniz Technical University

研究点 (1)

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