The Effect of Music Therapy on Comfort, Pain and Anxiety

NCT ID: NCT05895357

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-06-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music Therapy

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.

Group Type: EXPERIMENTAL

Musictherapy

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Musictherapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

seda şahan

Phd research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kayseri City Hospital

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 38867235 (View on PubMed)

Other Identifiers

820

Identifier Type: -

Identifier Source: org_study_id