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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04299256
Other study ID # 4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date October 1, 2019

Study information

Verified date March 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study carried out in the HD unit of a large-scale training and research hospital, and at a dialysis center associated with this hospital located in Ankara, Turkey. Participants will be randomized to one of two study arms.

Arm 1: Intervention group Arm 2: Control group Hypothesis 1. The HD patients in the 8-week intervention of BRT combined with music therapy will report lower fatigue scores than those in the control group.

Hypothesis 2. The HD patients in the 8-week intervention of BRT combined with music therapy will perceive lower anxiety and depression than those in the control group.


Description:

Patients undergoing hemodialysis treatment are susceptible to many complications. The inadequate stress-coping strategies render them vulnerable to high symptom burden and impaired quality of life. Patients are given conventional treatments to stop or slow down the progress of nephron destruction and prevent complications associated with uremia. However, previous studies observed that these therapies may be limited in alleviating fatigue, anxiety, and symptoms of depression, and may pose severe side effects. Therefore, in recent years patients have shown enhanced tendency to use complementary and integrative approaches including aromatherapy, acupuncture, massage, music, and relaxation to provide better control on their health and treatment process, feeling better physically, and emotionally, and as well as improve quality of life. The present study investigates the effects of Benson relaxation technique combined with music therapy in two-centered, 2-arm, assessor blinded randomized, controlled study of 61 hemodialysis patients.

Arm 1: Benson relaxation technique combined with music therapy ; Arm 2: control. The investigators hypothesize that Benson relaxation technique combined with music therapy will decrease severity of fatigue, anxiety, and depression.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who were 18 years and older,

- Capable of communicating in Turkish,

- Had received HD in last three months,

- Undergone HD at least two times in a week,

- Showed a willingness to participate in this study.

Exclusion Criteria:

- Patients with aggravated conditions who would not be able to continue with the study,

- Other accompanying diseases that significantly affect the fatigue like COPD, advanced,

- Heart failure, asthma, and malignant tumors,

- Diagnosed with major depression,

- Could not communicate in Turkish,

- Used another complementary and integrative approach within the study period.

Study Design


Intervention

Behavioral:
Benson relaxation combined with music therapy
In the first interview, the patient information delivered a training booklet explaining the definition, purpose, benefits and application techniques of BRT and music therapy to the patients in the intervention group. After patients reviewed the details in the training booklet, a weekly schedule was planned for each patient based on their hemodialysis days. For the initiation of the intervention, patients were invited to the hemodialysis unit at the hospital 45 min prior to their hemodialysis sessions. All the participants wore black eye patches to provide a dim environment and to focus better on their breath and the music piece. Then, the patients information opened the music piece and gave Benson Relaxation Technique comments in a slightly lower voice. Each session lasted for 20 min, and the music piece was switched off as Benson Relaxation Technique ended. The music piece used in the study was Daniel Kobelco's non-verbal classical song.

Locations

Country Name City State
Turkey Ankara Training and Research Hospital Hemodialysis Units Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fatigue severity Fatigue severity will be measured based on patient report by the Piper Fatigue Scale. Higher score means increase in fatigue severity. Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
Primary Change in anxieyt and depression level. Anxiety and depression will be measured by the Hospital Anxiety and Depression Scales. Higher scores on the scale mean worse anxiety and depression severity. Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
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