- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238374
The Effect of Various Music Therapies and Robotic Parrot Therapy on Anxiety and Fatigue Levels
The Effect of Various Music Therapies and Robotic Parrot Therapy on Anxiety and Fatigue Levels in Hemodialysis Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
Although the life-saving effects of hemodialysis treatment are indisputable, this treatment process can also bring serious problems. In particular, the frequency and length of hemodialysis sessions, inherent in their nature, cause physical exhaustion in patients and also create a significant psychological burden. Clinical studies and observational research have demonstrated that high levels of anxiety and persistent fatigue are frequently observed in patients undergoing hemodialysis. The prevalence of these symptoms is a consistent finding that negatively affects both patients' overall quality of life and their adherence to the treatment regimen. In this context, in addition to standard medical treatment approaches, the need for holistic and non-pharmacological support methods focused on supporting patients' psychological well-being has become critically important.
In line with this need, complementary practices such as music therapy and pet therapy are gaining increasing attention in the field of chronic disease management. Music therapy has emerged as an effective tool in alleviating symptoms such as anxiety, depression, and pain in hemodialysis patients, as demonstrated by evidence-based studies. The positive effects of listening to instrumental music or music selected by the patient on psychological symptoms are also supported by meta-analyses. However, while the vast majority of studies in music therapy focus on passive listening, the effects of different instrumental types of live music, which may have a higher therapeutic effect, have not been sufficiently investigated. In particular, there are very few studies examining the specific and comparative interactions on the symptom of fatigue, which is common and difficult to treat in hemodialysis patients. Therefore, a deeper understanding of the mechanisms of action of different live music approaches is a primary research requirement.
On the other hand, pet therapy has been clearly proven to reduce anxiety and loneliness levels in studies conducted on the general population and psychiatric patients. Parrots, in particular, have been used in therapeutic work due to their social interaction and vocal mimicry abilities. In the reviewed literature, only one unpublished doctoral thesis has been found internationally that uses live parrot therapy in mental health. In Turkey, no studies using parrot therapy have been found. However, the introduction of live animals into environments with high infection risks, such as dialysis units, is not recommended due to practical and ethical barriers, including strict hygiene standards and allergy potential. These limiting factors create a need for robotic alternatives that can mimic the social interaction and distraction benefits of pet therapy.
In this context, robotic parrots are an innovative tool that can deliver the benefits of pet therapy without hygiene and safety concerns. Previous research has shown that parrot-inspired robots are successful in capturing the attention and increasing the social participation of individuals who experience difficulties in social interaction. Therefore, it is thought that the use of such interactive robotic parrots with sound and music repetition features during hemodialysis sessions could create a new source of emotional and cognitive support for patients and have a positive effect on symptoms such as anxiety and fatigue.
Considering all this information, this study aims to compare the effects of robotic parrot therapy and different instrumental live music therapy approaches on anxiety and fatigue in hemodialysis patients for the first time using a double-blind randomized controlled design. The scientific data obtained will guide the development of evidence-based and innovative intervention protocols that support traditional medical care .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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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,
- Receiving hemodialysis treatment 3 times per week,
- Having received regular hemodialysis treatment for at least 6 months,
- Being conscious and able to communicate, with no impairment in mental and cognitive functions,
- Not having previously received music therapy or pet therapy.
Exclusion Criteria:
- Refusal to participate in the study,
- Being 18 years of age or younger,
- Having severe hearing loss,
- Hemodynamic status not being stable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Music-Repeating Robotic Parrot
Before the study (week 0/pre-test), data were collected from all participants using the "Patient Information Form", "Fatigue Severity Scale" and "Beck Anxiety Scale".
The "Fatigue Severity Scale" and "Beck Anxiety Scale" were re-administered at the end of the 1st and 2nd months of the therapy process.
Following the end of the application, patients were monitored without therapy for 8 weeks, and these scales (Fatigue Severity Scale and Beck Anxiety Scale) were evaluated for the last time in the 3rd and 4th months (16th week/final test).
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Patients in the experimental groups underwent 30-minute therapy sessions 3 days a week for 8 weeks.
In robotic parrot therapy, patients were asked to sing and listen to the robotic parrot's repetition.
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Experimental: Live Music
Before the study (week 0/pre-test), data were collected from all participants using the "Patient Information Form", "Fatigue Severity Scale" and "Beck Anxiety Scale".
The "Fatigue Severity Scale" and "Beck Anxiety Scale" were re-administered at the end of the 1st and 2nd months of the therapy process.
Following the end of the application, patients were monitored without therapy for 8 weeks, and these scales (Fatigue Severity Scale and Beck Anxiety Scale) were evaluated for the last time in the 3rd and 4th months (16th week/final test).
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Patients in the experimental groups underwent 30-minute therapy sessions 3 days a week for 8 weeks.
In live music therapy, songs were performed accompanied by instruments such as guitar and darbuka.
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Experimental: Live Ney Sound
Before the study (week 0/pre-test), data were collected from all participants using the "Patient Information Form", "Fatigue Severity Scale" and "Beck Anxiety Scale".
The "Fatigue Severity Scale" and "Beck Anxiety Scale" were re-administered at the end of the 1st and 2nd months of the therapy process.
Following the end of the application, patients were monitored without therapy for 8 weeks, and these scales (Fatigue Severity Scale and Beck Anxiety Scale) were evaluated for the last time in the 3rd and 4th months (16th week/final test).
|
Patients in the experimental groups underwent 30-minute therapy sessions 3 days a week for 8 weeks.
In live ney sound therapy, only instrumental music was performed using the ney.
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No Intervention: Control Group
Patients in this group did not receive any intervention from the researcher for 16 weeks.
The "Patient Information Form," "Fatigue Severity Scale" and "Beck Anxiety Scale" were administered at the pre-test.
Subsequently,"Fatigue Severity Scale" and "Beck Anxiety Scale" measurements were repeated in the 1st, 2nd, 3rd, and 4th months (16th week/final test).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fatigue Severity Scale
Time Frame: 16 week
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The scale generally consists of 9 items. The items inquire about the effect of fatigue on cognitive functions such as motivation, exercise, physical functioning, daily living activities, and attention/concentration. The rating uses a 7-point Likert-type format. The individual indicates their level of agreement with each item by selecting a score between 1 (strongly disagree) and 7 (strongly agree). The total score ranges from 9 to 63. A total score of 36 or higher generally indicates the presence of clinically significant fatigue. Before the study (week 0/pre-test), data were collected from all participants using the "Fatigue Severity Scale". The Fatigue Severity Scale were re-administered at the end of the 1st and 2nd months of the therapy process. Following the end of the application, patients were monitored without therapy for 8 weeks, and these scale were evaluated for the last time in the 3rd and 4th months (16th week/final test). |
16 week
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Beck Anxiety Scale
Time Frame: 16 week
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The Scale measures both the cognitive/emotional and somatic (physical) components of anxiety, asking participants to rate the degree to which each symptom has bothered them in the past week on a scale from 0 (Not at all) to 3 (To a great extent). The total score obtained from the scale, ranging from 0 to 63, reflects the severity of anxiety; according to common interpretation, a score between 8 and 15 indicates mild anxiety, between 16 and 25 indicates moderate anxiety, and between 26 and 63 indicates severe anxiety. Before the study (week 0/pre-test), data were collected from all participants using the "Beck Anxiety Scale". TheBeck Anxiety Scale were re-administered at the end of the 1st and 2nd months of the therapy process. Following the end of the application, patients were monitored without therapy for 8 weeks, and these scale were evaluated for the last time in the 3rd and 4th months (16th week/final test). |
16 week
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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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anxiety Disorders
- Fatigue
- Renal Insufficiency, Chronic
- 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
- RCS04082023
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
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