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

Primary Purpose

Hemodialysis Complication, Fatigue, Anxiety Depression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Benson relaxation combined with music therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodialysis Complication focused on measuring anxiety, depression, fatigue, hemodialysis, music therapy, relaxation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara Training and Research Hospital Hemodialysis Units

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Benson relaxation combined with music therapy

Control

Arm Description

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.

Like the intervention group, the control group session (attention-matched education) which composed of 10-12 participants were performed with a booklet containing hemodialysis and its use in a silent room located in the hemodialysis units. The patient information provided in-person training on hemodialysis and its use for 20 min in a group session at the hemodialysis unit, on the first day of the study. During the study period, the participants in the control group were not subjected to any additional intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2020
Last Updated
March 13, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04299256
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication, Fatigue, Anxiety Depression
Keywords
anxiety, depression, fatigue, hemodialysis, music therapy, relaxation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benson relaxation combined with music therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Like the intervention group, the control group session (attention-matched education) which composed of 10-12 participants were performed with a booklet containing hemodialysis and its use in a silent room located in the hemodialysis units. The patient information provided in-person training on hemodialysis and its use for 20 min in a group session at the hemodialysis unit, on the first day of the study. During the study period, the participants in the control group were not subjected to any additional intervention.
Intervention Type
Behavioral
Intervention Name(s)
Benson relaxation combined with music therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in fatigue severity
Description
Fatigue severity will be measured based on patient report by the Piper Fatigue Scale. Higher score means increase 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.
Title
Change in anxieyt and depression level.
Description
Anxiety and depression will be measured by the Hospital Anxiety and Depression Scales. Higher scores on the scale mean worse anxiety and depression 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hacer Oturmaz, MsC, RN
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital Hemodialysis Units
City
Ankara
ZIP/Postal Code
06080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35435875
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.
Results Reference
derived

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

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