Bone Marrow DiseaseNCT05895357
The Effect of Music Therapy on Comfort, Pain and Anxiety
A study testing Musictherapy in people with Bone Marrow Disease and Hematological Malignancy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone Marrow Disease, Hematological Malignancy
- What is being tested?
- Musictherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hearing impairment
- hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
- Sever anxiety disorder
- Parkinson's disease
- Alzheimer's disease
- Dementia
- Major depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research
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
- Being tested
- Musictherapy
- Keywords
- bone marrow, aspiration, biopsy, musictherapy, anxiety, pain, comfort
- Medical subject headings
- Bone Marrow Diseases, Hematologic Neoplasms, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusictherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (1)
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Apr 2023
- Primary completion30 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seda şahan, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895357
- Sponsor's protocol ID
- 820
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Other researchers can get information by sending an e-mail to the responsible researcher of this study. (seda.sahan@bakircay.edu.tr)
Publications
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.
PubMed 38867235
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT05895357
- Acronym / sponsor ID
- 820
- Conditions
- Bone Marrow Disease, Hematological Malignancy
- Keywords
- bone marrow, aspiration, biopsy, musictherapy, anxiety, pain, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: MusictherapyThe 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 | 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Hearing impairment
- hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
- Sever anxiety disorder
- Parkinson's disease
- Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusictherapyThe 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 | Music Therapy |
Primary outcome
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.
1 secondary outcome
State Trait Anxiety Scale (STAI)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 38867235Sahan 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musictherapy in people with Bone Marrow Disease and Hematological Malignancy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain and Comfort (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.