Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-04 @ 6:32 PM
Study NCT ID:
NCT07238361
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Animal Interventions on Pain and Anxiety Levels Due to Port Catheter Needle Entry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Day 1', 'description': '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.\n\n"VAS" were administered to the patients 2 times in total before the study (pretest) and the end of the end of the survey (posttest).'}, {'measure': 'State-Trait Anxiety Inventory-I (STAI-I)', 'timeFrame': 'Day 1', 'description': '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\n\n"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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Anxiety', 'Animal therapy', 'Nursing', 'Palliative care.'], 'conditions': ['Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Agreement to participate in the study,\n* Being able to communicate verbally,\n* No vision, hearing, or speech problems,\n* The patient must have a port catheter,\n* The patient must be able to access the implantable port catheter needle in a single attempt,\n\nExclusion Criteria:\n\n* Refusal to participate in the study,\n* Resence of a psychiatric disorder,\n* Unstable general condition were determined as exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07238361', 'briefTitle': 'Effect of Different Animal Interventions on Pain and Anxiety Levels Due to Port Catheter Needle Entry', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RCS03072024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sultan Parrot', 'description': '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.', 'interventionNames': ['Behavioral: Sultan Parrot Therapy (Pet Therapy)']}, {'type': 'EXPERIMENTAL', 'label': 'Betta Fish', 'description': '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.', 'interventionNames': ['Behavioral: Betta Fish Therapy (Pet Therapy)']}, {'type': 'EXPERIMENTAL', 'label': 'Red-Eared Slider Turtle Group', 'description': '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.', 'interventionNames': ['Behavioral: Red-Eared Slider Turtle Therapy (Pet Therapy)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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".'}], 'interventions': [{'name': 'Sultan Parrot Therapy (Pet Therapy)', 'type': 'BEHAVIORAL', 'description': 'Sultan parrot therapy was applied during implantable port catheter needle insertion', 'armGroupLabels': ['Sultan Parrot']}, {'name': 'Betta Fish Therapy (Pet Therapy)', 'type': 'BEHAVIORAL', 'description': 'Betta fish therapy was applied during implantable port catheter needle insertion.', 'armGroupLabels': ['Betta Fish']}, {'name': 'Red-Eared Slider Turtle Therapy (Pet Therapy)', 'type': 'BEHAVIORAL', 'description': 'Red-eared slider turtle therapy was applied during implantable port catheter needle insertion.', 'armGroupLabels': ['Red-Eared Slider Turtle Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29600', 'city': 'Gümüşhane', 'country': 'Turkey (Türkiye)', 'facility': 'Gümüşhane University', 'geoPoint': {'lat': 40.46001, 'lon': 39.47176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "I'll decide later"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hatice Demirağ, Ph.D', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}