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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Jul 2024
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2024
CompletedFirst Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 20, 2025
CompletedNovember 20, 2025
November 1, 2025
3 months
November 14, 2025
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Analogue Scale (VAS)
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
State-Trait Anxiety Inventory-I (STAI-I)
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
Study Arms (4)
Sultan Parrot
EXPERIMENTALBefore 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.
Betta Fish
EXPERIMENTALBefore 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.
Red-Eared Slider Turtle Group
EXPERIMENTALBefore 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.
Control Group
NO INTERVENTIONNo 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".
Interventions
Sultan parrot therapy was applied during implantable port catheter needle insertion
Betta fish therapy was applied during implantable port catheter needle insertion.
Red-eared slider turtle therapy was applied during implantable port catheter needle insertion.
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- Refusal to participate in the study,
- Resence of a psychiatric disorder,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gümüşhane University
Gümüşhane, 29600, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 20, 2025
Study Start
July 2, 2024
Primary Completion
September 22, 2024
Study Completion
October 7, 2024
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
I'll decide later