Clinical trial NCT05895357: The Effect of Music Therapy on Comfort, Pain and Anxiety
Official title: The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Disease
Hematological Malignancy
Keywords: bone marrow
aspiration
biopsy
musictherapy
anxiety
pain
comfort
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: This study was conducted to determine the effect of music therapy on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy.

Methods: This research was conducted as a randomized controlled study in the hematology polyclinic of a university hospital. Music therapy will used with the intervention group throughout the procedure. During data evaluation, paired t-test, independent t-test and effect size will used. The sample group was calculated based on the sample groups of other studies in the literature (Çelebi et al., 2020; Özdemir et al., 2019). According to the preliminary power analysis results using the G.Power 3.1.9 program, the sample size was calculated at 80% power, at medium effect size at 5% alpha value. According to the analysis results, the sample size per group was calculated as 30. However, since there was 10% probability that some patients may drop, the sample size for the study was recalculated as 66 (Experimental Group: 33, Control Group: 33).The patients will informed about using music. In addition, it will explained that they could adjust the sound levels and that they should report when they are disturbed by the tone. Music continued throughout the process. Communication with the patient will maintained, and symptoms such as discomfort, anxiety were observed throughout the procedure. The music player will switched off after the procedure was completed. The patients will asked whether they had any discomfort while the music played. TThe music therapy will last an average of 30 minutes. After completing the procedures, the patient's pain, comfort, and anxiety levels were re-evaluated using VAS and STAI.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hematological malignancy (defined as multiple myeloma, Chronic Lymphocytic Leukaemia, Myelodysplastic syndrome or indolent lymphoma)
* 18 years of age or older,
* Must be able to speak Turkish

Exclusion Criteria:

* Hearing impairment
* hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
* Sever anxiety disorder
* Parkinson's disease
* Alzheimer's disease
* Dementia
* Major depression

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain and Comfort
timeFrame: 10 minutes
Secondary outcomes:
measure: State Trait Anxiety Scale (STAI)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
Study officials:
References: