The Effect of Various Music Therapies and Robotic Parrot Therapy on Anxiety and Fatigue Levels

NCT ID: NCT07238374

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2024-02-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Failure Chronic Anxiety Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sample size was calculated using the G\*Power 3.1.9.6 program with an error rate of α=0.05. Since there were no previous four-group studies on the subject, no reference could be used. with an effect size of 0.2 and a target test power of 0.80 (90%), a total of 68 patients (17 per group) were calculated for the four groups (music-repeating robotic parrot, live music, live ney sound, and control group). Taking into account situations such as wanting to leave the study or death during the research, each group was increased by 10%, and a total of 76 patients were included in the study, with 19 patients in each group. The study was completed with 64 HD patients.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
After explaining the purpose of the study and completing the consent forms, the researcher conducted a double-blind randomized controlled clinical trial to reduce bias. In this context, the two researchers who applied the data collection tools and the third researcher who analyzed the data were not informed about which experimental groups (music-repeating robotic parrot, live music, live ney sound) or control group the hemodialysis patients were in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Music-Repeating Robotic Parrot (Pet therapy)

Intervention Type OTHER

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.

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).

Group Type EXPERIMENTAL

Live Music (Pet therapy)

Intervention Type OTHER

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.

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).

Group Type EXPERIMENTAL

Live Ney Sound (Pet therapy)

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music-Repeating Robotic Parrot (Pet therapy)

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.

Intervention Type OTHER

Live Music (Pet therapy)

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.

Intervention Type OTHER

Live Ney Sound (Pet therapy)

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hatice Demirağ, Ph.D

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gümüşhane University

Gümüşhane, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RCS04082023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound for Healthy Aging
NCT07168525 RECRUITING NA