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

NCT07238374 | Completed

• 1 other identifier: RCS04082023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Failure Chronic; Anxiety; Fatigue

Keywords

Anxiety; Complementary therapies; Fatigue; Hemodialysis; Music therapy

Outcome Measures

Primary Outcomes (2)

• 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).

  16 week

• 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).

  16 week

Study Arms (4)

Music-Repeating Robotic Parrot

EXPERIMENTAL

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).

Other: Music-Repeating Robotic Parrot (Pet therapy)

Live Music

EXPERIMENTAL

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).

Other: Live Music (Pet therapy)

Live Ney Sound

EXPERIMENTAL

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).

Other: Live Ney Sound (Pet therapy)

Control Group

NO INTERVENTION

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).

Interventions

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.

Music-Repeating Robotic Parrot

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 Music

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.

Live Ney Sound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Gümüşhane University

Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anxiety Disorders; Fatigue

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: October 12, 2023
• Primary Completion: December 12, 2023
• Study Completion: February 12, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)