PainNCT07238361
Effect of Different Animal Interventions on Pain and Anxiety Levels Due to Port Catheter Needle Entry
A study testing Sultan Parrot Therapy (Pet Therapy), Betta Fish Therapy (Pet Therapy) and Red-Eared Slider Turtle Therapy (Pet Therapy) in people with Pain and Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sultan Parrot Therapy (Pet Therapy), Betta Fish Therapy (Pet Therapy) and Red-Eared Slider Turtle Therapy (Pet Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2024to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- Refusal to participate in the study,
- Resence of a psychiatric disorder,
- Unstable general condition were determined as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Sultan Parrot Therapy (Pet Therapy), Betta Fish Therapy (Pet Therapy), Red-Eared Slider Turtle Therapy (Pet Therapy)
- Keywords
- Pain, Anxiety, Animal therapy, Nursing, Palliative care.
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sultan Parrot Therapy (Pet Therapy)Behavioural
Sultan parrot therapy was applied during implantable port catheter needle insertion
Betta Fish Therapy (Pet Therapy)Behavioural
Betta fish therapy was applied during implantable port catheter needle insertion.
Red-Eared Slider Turtle Therapy (Pet Therapy)Behavioural
Red-eared slider turtle therapy was applied during implantable port catheter needle insertion.
| Study group | Role | What they receive |
|---|---|---|
| Sultan Parrot | Experimental | 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. Receives: Behavioral: Sultan Parrot Therapy (Pet Therapy) |
| Betta Fish | Experimental | 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. Receives: Behavioral: Betta Fish Therapy (Pet Therapy) |
| Red-Eared Slider Turtle Group | Experimental | 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. Receives: Behavioral: Red-Eared Slider Turtle Therapy (Pet Therapy) |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start2 Jul 2024
- Primary completion22 Sep 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Considering accessibility, a total of 120 patients (4 groups each) who had their port catheter needles changed were included in the study . After completion of the study, a post-hoc power analysis performed using the G\*Power 3.1.9.7 program found the statistical power of the test to be 92% with an error rate of α:0.05 and an observed effect size of f=0.38.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Demirağ, Ph.D, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238361
- Sponsor's protocol ID
- RCS03072024
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'll decide later
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07238361
- Acronym / sponsor ID
- RCS03072024
- Keywords
- Pain, Anxiety, Animal therapy, Nursing, Palliative care.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Considering accessibility, a total of 120 patients (4 groups each) who had their port catheter needles changed were included in the study . After completion of the study, a post-hoc power analysis performed using the G*Power 3.1.9.7 program found the statistical power of the test to be 92% with an error rate of α:0.05 and an observed effect size of f=0.38.
| Arm | Type | Receives |
|---|---|---|
| Sultan Parrot | Experimental | Behavioral: Sultan Parrot Therapy (Pet Therapy)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. |
| Betta Fish | Experimental | Behavioral: Betta Fish Therapy (Pet Therapy)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. |
| Red-Eared Slider Turtle Group | Experimental | Behavioral: Red-Eared Slider Turtle Therapy (Pet Therapy)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. |
| Control Group | No intervention | –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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- Refusal to participate in the study,
- Resence of a psychiatric disorder,
- Unstable general condition were determined as exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sultan Parrot Therapy (Pet Therapy)Sultan parrot therapy was applied during implantable port catheter needle insertion | Behavioural | Sultan Parrot |
| Betta Fish Therapy (Pet Therapy)Betta fish therapy was applied during implantable port catheter needle insertion. | Behavioural | Betta Fish |
| Red-Eared Slider Turtle Therapy (Pet Therapy)Red-eared slider turtle therapy was applied during implantable port catheter needle insertion. | Behavioural | Red-Eared Slider Turtle Group |
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. I'll decide later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sultan Parrot Therapy (Pet Therapy), Betta Fish Therapy (Pet Therapy) and Red-Eared Slider Turtle Therapy (Pet Therapy) in people with Pain and Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.