- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298837
Turtle Therapy on HbA1c and Self-Efficacy Levels With Type 2 Diabetes
The Effect of Turtle Therapy on HbA1c and Self-Efficacy Levels in Diabetes Medication Use in Individuals With Type 2 Diabetes: A Double-Blind Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gümüşhane, Turkey (Türkiye), 29600
- Gumushane University
-
-
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 literate,
- Being able to communicate verbally,
- No vision, hearing, or speech impairments,
- Agreeing to adopt and care for a turtle (turtle group),
- Ownership of a smartphone, tablet, or computer (video turtle group),
- Having been diagnosed with T2DM and having been receiving DM treatment for at least 6 months,
- HbA1c >7%.
Exclusion Criteria:
- Refusal to participate in the study,
- Not having T2DM,
- Having received DM treatment for less than 6 months,
- Having a psychiatric disorder diagnosed by a psychiatrist.
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 Turtle Group
Before starting the study, a nurse who was unaware of the study details (to prevent bias) administered the "Structured Patient Information Form" and "Diabetes Medication Self-Efficacy Scale", and the "hemoglobin A1c " value measured immediately before the study began was recorded.
At the end of the three-month pet therapy period, the same nurse administered the "Diabetes Medication Self-Efficacy Scale" test, and the physician recorded the "hemoglobin A1c" value result as requested.
During this process, patients continued their routine Type 2 Diyabetus Mellitus treatment.
|
The individuals were asked to take on the responsibility of caring for the turtles.
The patients in this group were given one turtle and the necessary materials (aquarium, food, aquarium sand, etc.) for 12 weeks.
Within this scope, patients fed the turtles twice a day, once in the morning (08:00) and once in the evening (20:00), and changed the water in the aquarium every two days with water that had been kept at room temperature beforehand.
In addition, they were asked to spend 20 minutes a day with the turtle.
During the twelve-week (3-month) period in which the individuals took responsibility for turtle care, the "Turtle Monitoring Form" was administered by the executor to evaluate the time spent with the turtle and the implementation of practices related to how they performed turtle care.
|
|
Experimental: Video Turtle Group
Before starting the study, a nurse who was unaware of the study details (to prevent bias) administered the "Structured Patient Information Form" and "Diabetes Medication Self-Efficacy Scale", and the "hemoglobin A1c" value result measured immediately before the study began was recorded.In addition, at the end of the three-month pet therapy period, the same nurse administered the "Diabetes Medication Self-Efficacy Scale" and the physician recorded the "hemoglobin A1c" value result requested.
During this process, patients continued their routine Type 2 Diyabetus Mellitus treatment.
|
In addition, the consultant faculty member provided approximately 15 minutes of face-to-face information to patients regarding watching the turtle videos.
Patients in this group were asked to watch documentaries featuring turtle videos for at least 20 minutes a day for twelve weeks.
The "Turtle Viewing Form" was administered by the researcher to determine how many minutes per day the individuals watched the turtle videos.
|
|
No Intervention: Control Group
A nurse who was unaware of the study details prior to its commencement (to prevent bias) administered the "Structured Patient Information Form" and "Diabetes Medication Self-Efficacy Scale", and the "hemoglobin A1c" value result obtained immediately before the study began was recorded.
No intervention was performed on these patients.
Patients only continued their routine Type 2 Diyabetus Mellitus treatments.
In addition, "Diabetes Medication Self-Efficacy Scale" was administered to patients at the end of the three-month period, and the "hemoglobin A1c" value requested by the physician was recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin A1c
Time Frame: 12 week
|
Hemoglobin A1c is a clinically useful index of average blood glucose levels over the past 120 days (average red blood cell lifespan). It most accurately reflects glycemic control over the past 2-3 months. Hemoglobin A1c was measured twice, before and after the study. |
12 week
|
|
Diabetes Medication Self-Efficacy Scale
Time Frame: 12 week
|
Diabetes Medication Self-Efficacy Scale was developed by Sleath and colleagues (2016) to assess self-efficacy in overcoming barriers to diabetes medication use. Its Turkish validity and reliability were established by Kavuran & Türkoğlu (2022) using a 19-item, 3-point Likert-type scale. The scale consists of three subscales: "Requirement" (items 1-4), "Busyness" (items 5-9), and "Worry" (items 10-19). The scale scores range from 19 (low self-efficacy) to 57 (high self-efficacy). Diabetes Medication Self-Efficacy Scale was measured twice, before and after the study. |
12 week
|
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
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Behavior
- Nutritional and Metabolic Diseases
- Human-Animal Interaction
- Diabetes Mellitus, Type 2
- Human-Animal Bond
- 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
- RCS04072024
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.
Clinical Trials on Type 2 Diabetes Mellitus
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... and other collaboratorsNot yet recruitingType 2 Diabetes | Diabetes Mellitus Type 2Turkey (Türkiye)
-
Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruiting
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
-
University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Enrolling by invitationType 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes MellitusPortugal
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
-
Kaiser PermanenteThe Permanente Medical GroupEnrolling by invitationType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)United States
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not yet recruitingT2DM (Type 2 Diabetes Mellitus)United States
Clinical Trials on Live Turtle Therapy (Pet therapy)
-
Karadeniz Technical UniversityCompletedPain | AnxietyTurkey (Türkiye)
-
Karadeniz Technical UniversityCompletedFatigue | Anxiety | Renal Failure ChronicTurkey (Türkiye)
-
Karadeniz Technical UniversityGümüşhane UniversıtyCompletedPain | Chronic DiseaseTurkey (Türkiye)
-
Children's Healthcare of AtlantaCompletedRespiratory Syncytial Virus InfectionsUnited States
-
University of PennsylvaniaConestoga High SchoolCompletedStress | Cognitive Impairment | DementiaUnited States
-
University Medical Center GroningenNot yet recruitingCritical Illness
-
Claudia AristizábalSONO; keralty; Clinica El Carmen; Clínica Sebastián de BelalcazarNot yet recruitingAnxiety State | Well-Being, PsychologicalColombia
-
University of British ColumbiaChild and Family Research Institute; American Music Therapy Association; Canuck... and other collaboratorsCompleted
-
Murdoch Childrens Research InstituteNot yet recruitingDisorder of Consciousness | Acquired Brain InjuryAustralia
-
Tokat Gaziosmanpasa UniversityCompletedPet Therapy Effect of Sleep and Quality of LifeTurkey