Fatigue Clinical Trial
Official title:
Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Study
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 |
Verified date | March 2020 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Training and Research Hospital Hemodialysis Units | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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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