- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241780
Parrot Therapy on Pain During Venous Blood Collection in Individuals With Chronic Diseases
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gümüşhane, Turkey (Türkiye), 29600
- Gumushane University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal to give consent,
- Psychiatric diagnosis,
- Hemodynamic instability,
- Presence of Chronic Obstructive Pulmonary Disease/Asthma,
- Chronic disease duration of less than 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Live Parrot Group
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.
|
During venipuncture, until the procedure was completed, patients interacted with a "Sultan parrot" (watching and talking) for approximately 5 minutes, depending on their group.
|
|
Experimental: Robotic Parrot Group
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.
|
During venipuncture, until the procedure was completed, patients interacted with a "robotic parrot" (watching and talking, listening to music) for approximately 5 minutes, depending on their group.
|
|
Experimental: Picture Parrot Group
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.
|
During venipuncture, until the procedure was completed, patients interacted with a "parrot picture" (examining and looking at pictures) for approximately 5 minutes, depending on their group.
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 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. |
Day 1
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Agnosia
- Chronic Disease
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Animal Assisted Therapy
Other Study ID Numbers
- RCS02072024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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