Music TherapyNCT05980468
The Effect of Music Therapy on Nurses
A study testing music therapy in people with Music Therapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of music therapy on the comfort levels of nurses. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2023to 27 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least one year of working experience
- Have not participated in any music therapy session before
- No hearing problems
- Absence of neurological/psychiatric disorders
- Nurses who volunteered to participate in the study will be included in the study.
Who cannot join
- Those who use another relaxation methods,
- Nurses who do not agree to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on Nurses' Comfort Levels
This study was planned to examine the effect of music therapy on the comfort levels of nurses. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again.
Read the detailed description
This study was planned to examine the effect of music therapy on the comfort levels of nurses. This study will be conducted as a randomized controlled experimental study. In the sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the control group. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again. Research data will be analyzed in SPSS-25 package program.
- Conditions
- Music Therapy
- Being tested
- music therapy
- Keywords
- nurse, comfort, music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. Forms will be applied at the first meeting and for five weeks. Receives: Other: music therapy |
| Control group | No intervention | No application has been made. Forms will be applied at the first meeting and for five weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
The scale consists of 39 items in total. Each statement in the scale has a Likert-type rating ranging from 1-4 from "strongly disagree" to "strongly agree". 24 of the expressions are positive and 15 are negative, and negative items are reversed in scoring. Accordingly, a high score (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1) indicates high comfort in negative statements, and a high score (4) indicates low comfort. The Cronbach alpha coefficient was found to be 0.915.
Measured: 5 weeks after first meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start14 Aug 2023
- Primary completion18 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- Sevda Korkut, Principal investigator, TC Erciyes UniversityAyşe Topuz, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980468
- Sponsor's protocol ID
- 05/2023
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Nurses' Comfort Levels
- ClinicalTrials.gov ID
- NCT05980468
- Acronym / sponsor ID
- 05/2023
- Conditions
- Music Therapy
- Keywords
- nurse, comfort, music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 8 Aug 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.
This study was planned to examine the effect of music therapy on the comfort levels of nurses. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again.
Detailed description
This study was planned to examine the effect of music therapy on the comfort levels of nurses. This study will be conducted as a randomized controlled experimental study. In the sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the control group. In the study, data will be collected by using Descriptive Characteristics Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in the intervention or control group will be determined by simple randomization. Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the participants again. Research data will be analyzed in SPSS-25 package program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: music therapyMusic intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. Forms will be applied at the first meeting and for five weeks. |
| Control group | No intervention | –No application has been made. Forms will be applied at the first meeting and for five weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have at least one year of working experience
- Have not participated in any music therapy session before
- No hearing problems
- Absence of neurological/psychiatric disorders
- Nurses who volunteered to participate in the study will be included in the study.
Key exclusion criteria (2 listed)
- Those who use another relaxation methods,
- Nurses who do not agree to participate in the study will not be included in the study.
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 |
|---|---|---|
| music therapyMusic intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session. | Other | Intervention group |
Primary outcome
Comfort
Time frame: 5 weeks after first meeting
The scale consists of 39 items in total. Each statement in the scale has a Likert-type rating ranging from 1-4 from "strongly disagree" to "strongly agree". 24 of the expressions are positive and 15 are negative, and negative items are reversed in scoring. Accordingly, a high score (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1) indicates high comfort in negative statements, and a high score (4) indicates low comfort. The Cronbach alpha coefficient was found to be 0.915.
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 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Sevda Korkut principal investigator
TC Erciyes University
Ayşe Topuz principal investigator
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Music Therapy, run by TC Erciyes 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 5 inclusion and 2 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 10 Oct 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?
Comfort (time frame: 5 weeks after first meeting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.