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NCT Number: NCT05895357

The Effect of Music Therapy on Comfort, Pain and Anxiety

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, 38000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musictherapy

Other

The patients were asked about the type of music they wanted to listen to. Especially in the last meta-analyses, it was determined that listening to the music that patients chose was more effective (Witten 2020). For this reason, after the intervention group is asked about the music they want to listen to, the music they want will be played from the music application.

Primary outcomes

  1. Visual Analog Scale (VAS) Pain and Comfort

    Time frame: 10 minutes

    The scale, used to measure patients' subjective pain and comfort, was developed by Price et al. (1983) (Price et al., 1983). This scale consists of a 10 cm horizontal or vertical line with both ends representing the minimum and maximum scores for pain and comfort (0: no pain/no discomfort (very comfortable), 10: most severe pain/very uncomfortable (not at all). Comfort was defined by patients as a pleasant feeling and as the absence of physical discomfort. The patients will asked to indicate their pain severity and comfort on the scale. The distance between the indicated point and the lowest endpoint of the line will measured in centimeters using a ruler, and the numeric value will assigned as the individual's pain score.

Secondary outcomes

  1. State Trait Anxiety Scale (STAI)

    Time frame: 10 minutes

    The inventory consisting 40 items was developed by Spielberger et al. (1983) (Spielberger, 1983). The STAI consists of two separate scales to assess state (STAI-S) and trait (STAI-T) anxiety. Öner (1998) performed the Turkish validity and reliability studies of the scale. In the validity and reliability study of the STAI Turkish form, test-retest reliability coefficients ranged from 0,94 to 0,96 for state anxiety and ranged from 0,83 and 0,87 for trait anxiety. The State Anxiety Inventory with 20 items (Items 1-20) that assess the respondent's current feelings was used in this study. Each item is rated on a 4-point Likert scale from 1 (Almost never) to 4 (Almost always). Subscale scores range from 20 to 80, and higher scores indicate higher anxiety levels

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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