Hemodialysis ComplicationNCT04299256
Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients
A study testing Benson relaxation combined with music therapy in people with Hemodialysis Complication and Fatigue, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Fatigue, Anxiety Depression
- What is being tested?
- Benson relaxation combined with music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital Hemodialysis Units
Ankara, 06080
About this study
Official title: Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Hemodialysis Complication, Fatigue, Anxiety Depression
- Being tested
- Benson relaxation combined with music therapy
- Keywords
- anxiety, depression, fatigue, hemodialysis, music therapy, relaxation
- Medical subject headings
- Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson relaxation combined with music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Benson relaxation combined with music therapy | Experimental | 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. Receives: Behavioral: Benson relaxation combined with music therapy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
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.
Measured: Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 May 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Oturmaz, Hacettepe University
- Investigators
- Hacer Oturmaz, MsC, RN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299256
- Sponsor's protocol ID
- 4
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35435875
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04299256
- Acronym / sponsor ID
- 4
- Conditions
- Hemodialysis Complication, Fatigue, Anxiety Depression
- Keywords
- anxiety, depression, fatigue, hemodialysis, music therapy, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benson relaxation combined with music therapy | Experimental | Behavioral: Benson relaxation combined with music therapyIn 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benson relaxation combined with music therapyIn 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. | Behavioural | Benson relaxation combined with music therapy |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 35435875Eroglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hacer Oturmaz, MsC, RN principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson relaxation combined with music therapy in people with Hemodialysis Complication and Fatigue, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.