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The Effect of Music Therapy on Comfort, Pain and Anxiety

Primary Purpose

Bone Marrow Disease, Hematological Malignancy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Musictherapy
Sponsored by
Izmir Bakircay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Marrow Disease focused on measuring bone marrow, aspiration, biopsy, musictherapy, anxiety, pain, comfort

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kayseri City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Therapy

No intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

State Trait Anxiety Scale (STAI)
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

Full Information

First Posted
May 31, 2023
Last Updated
July 25, 2023
Sponsor
Izmir Bakircay University
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1. Study Identification

Unique Protocol Identification Number
NCT05895357
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Disease, Hematological Malignancy
Keywords
bone marrow, aspiration, biopsy, musictherapy, anxiety, pain, comfort

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Musictherapy
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain and Comfort
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
State Trait Anxiety Scale (STAI)
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kayseri City Hospital
City
Kayseri
ZIP/Postal Code
38000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Other researchers can get information by sending an e-mail to the responsible researcher of this study. (seda.sahan@bakircay.edu.tr)

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The Effect of Music Therapy on Comfort, Pain and Anxiety

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