- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238361
Effect of Different Animal Interventions on Pain and Anxiety Levels Due to Port Catheter Needle Entry
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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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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:
- 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,
Exclusion Criteria:
- Refusal to participate in the study,
- Resence of a psychiatric disorder,
- Unstable general condition were determined as exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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Sultan parrot therapy was applied during implantable port catheter needle insertion
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Experimental: 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.
|
Betta fish therapy was applied during implantable port catheter needle insertion.
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Experimental: 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.
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Red-eared slider turtle therapy was applied during implantable port catheter needle insertion.
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No Intervention: 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".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: 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). |
Day 1
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State-Trait Anxiety Inventory-I (STAI-I)
Time Frame: 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). |
Day 1
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Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Mental Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Anxiety Disorders
- 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
- RCS03072024
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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