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Renal Failure ChronicNCT07238374

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

A study testing Music-Repeating Robotic Parrot (Pet therapy), Live Music (Pet therapy) and Live Ney Sound (Pet therapy) in people with Renal Failure Chronic and Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Failure Chronic, Anxiety, Fatigue
What is being tested?
Music-Repeating Robotic Parrot (Pet therapy), Live Music (Pet therapy) and Live Ney Sound (Pet therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Oct 2023to 12 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Refusal to participate in the study,
  • Being 18 years of age or younger,
  • Having severe hearing loss,
  • Hemodynamic status not being stable.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gümüşhane University

    Gümüşhane, 29600

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Various Music Therapies and Robotic Parrot Therapy on Anxiety and Fatigue Levels in Hemodialysis Patients: A Randomized Controlled Study

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.

Read the 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 .

Being tested
Music-Repeating Robotic Parrot (Pet therapy), Live Music (Pet therapy), Live Ney Sound (Pet therapy)
Keywords
Anxiety, Complementary therapies, Fatigue, Hemodialysis, Music therapy
Medical subject headings
Renal Insufficiency, Chronic, Anxiety Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music-Repeating Robotic Parrot (Pet therapy)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 (Pet therapy)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 (Pet therapy)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.

Study groups in NCT07238374
Study groupRoleWhat they receive
Music-Repeating Robotic ParrotExperimentalBefore 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).
Receives: Other: Music-Repeating Robotic Parrot (Pet therapy)
Live MusicExperimentalBefore 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).
Receives: Other: Live Music (Pet therapy)
Live Ney SoundExperimentalBefore 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).
Receives: Other: Live Ney Sound (Pet therapy)
Control GroupNo interventionPatients 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue Severity Scale

    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).

    Measured: 16 week

  2. Beck Anxiety Scale

    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).

    Measured: 16 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start12 Oct 2023
  3. Primary completion12 Dec 2023
  4. Study completion12 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238374
Sponsor's protocol ID
RCS04082023
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I'll decide later

Publications

  • Demirag H, Cin A, Aktepe Cosar D, Uzun S, Turkmen OO. The Effect of Music-Repeating Robotic Parrot Therapy and Different Instrumental Live Music Therapies on Anxiety and Fatigue Levels in Hemodialysis Patients: A Randomized Controlled Trial. Hemodial Int. 2026 Jul;30(3):605-616. doi: 10.1111/hdi.70075. Epub 2026 May 14.

    PubMed 42135264

Questions about this trial

What is this clinical trial studying?

A study testing Music-Repeating Robotic Parrot (Pet therapy), Live Music (Pet therapy) and Live Ney Sound (Pet therapy) in people with Renal Failure Chronic and Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue Severity Scale (time frame: 16 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07238374, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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