Gümüşhane University
Gümüşhane, 29600, Turkey (Türkiye)
NCT Number: NCT07238374
This study aimed to evaluate the effect of robotic parrot therapy, live music, and live ney sound therapy on anxiety and fatigue levels in hemodialysis patients.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Gümüşhane, 29600, Turkey (Türkiye)
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 16 week
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).
Time frame: 16 week
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).
Karadeniz Technical University
Other
The Effect of Various Music Therapies and Robotic Parrot Therapy on Anxiety and Fatigue Levels in Hemodialysis Patients: A Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06454981
Chronic Disease, Disease Attributes
Hangzhou, Zhejiang, China
View Trial DetailsNCT05787080
Chronic Disease, Disease Attributes
Ankara, Türkiye, Turkey (Türkiye)
View Trial DetailsNCT03246984
Arterio-venous Fistula, Arteriovenous Fistula
Paris, France
View Trial DetailsNCT05585268
Anemia, Cardiovascular Diseases
Montreal, Quebec, Canada
View Trial Details