Clinical trial NCT04299256: Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients
Official title: Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Fatigue
Anxiety Depression
Keywords: anxiety
depression
fatigue
hemodialysis
music therapy
relaxation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in fatigue severity
timeFrame: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
measure: Change in anxieyt and depression level.
timeFrame: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital Hemodialysis Units
Study officials:
affiliation: Hacettepe University
name: Hacer Oturmaz, MsC, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eroglu H, Gok Metin Z. Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Trial. Holist Nurs Pract. 2022 May-Jun 01;36(3):139-148. doi: 10.1097/HNP.0000000000000509.