The Effect of Music Therapy on Comfort, Pain and Anxiety

NCT05895357 | Completed

• 1 other identifier: 820
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Disease; Hematological Malignancy

Keywords

bone marrow; aspiration; biopsy; musictherapy; anxiety; pain; comfort

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Pain and Comfort

  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.

  10 minutes

Secondary Outcomes (1)

• State Trait Anxiety Scale (STAI)

  10 minutes

Study Arms (2)

Music Therapy

EXPERIMENTAL

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.

Other: Musictherapy

No intervention

NO INTERVENTION

The patients in the control group will not listen to music, and routine procedures will performed in the clinic without additional intervention. Anxiety, pain, and comfort assessments will made in the control group patients before and after the procedure.

Interventions

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.

Music Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (1)

• Sahan S, Korkmaz E, Korkmaz S. The effect of music on comfort, pain, and anxiety in patients with bone marrow aspiration and biopsy in Turkey: a mixed-methods study. BMC Complement Med Ther. 2024 Jun 12;24(1):228. doi: 10.1186/s12906-024-04531-0.

  PMID: 38867235 DERIVED

MeSH Terms

Conditions

Bone Marrow Diseases; Hematologic Neoplasms; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd research assistant

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: April 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 5, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TU (1)