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

NCT04299256 | Completed DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Fatigue; Anxiety Depression

Keywords

anxiety; depression; fatigue; hemodialysis; music therapy; relaxation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

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.

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.

Interventions

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.

Benson relaxation combined with music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara Training and Research Hospital Hemodialysis Units

Ankara, 06080, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35435875 DERIVED

MeSH Terms

Conditions

Fatigue; Anxiety Disorders; Depression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hacer Oturmaz, MsC, RN

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse, Principal Investigator

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 6, 2020
• Study Start: May 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)