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NCT Number: NCT04299256

Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients

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.

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Key information

Conditions

Hemodialysis Complication Anxiety Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Fatigue Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Training and Research Hospital Hemodialysis Units

Ankara, 06080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benson relaxation combined with music therapy

Behavioral

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.

Primary outcomes

  1. Change in fatigue severity

    Time frame: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.

    Fatigue severity will be measured based on patient report by the Piper Fatigue Scale. Higher score means increase in fatigue severity.

  2. Change in anxieyt and depression level.

    Time frame: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.

    Anxiety and depression will be measured by the Hospital Anxiety and Depression Scales. Higher scores on the scale mean worse anxiety and depression severity.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2020
Registry last updated
Mar 17, 2020

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.

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