AnxietyNCT07847138
The Effect of Music on Anxiety and Caregiver Burden in Family Caregivers of Patients With Lung Cancer
A study testing Music intervention in people with Anxiety and Evidence-based Practice, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of a 7-day self-selected music intervention on caregiver burden and anxiety among first-degree family caregivers of patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Evidence-based Practice, Caregiver Burden
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 30 Apr 2025
- 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
- The study included first-degree family members aged between 18 and 65 years who were caring for an individual diagnosed with lung cancer, who had been providing care for at least six months, who had no condition preventing communication or any hearing impairment, and who volunteered to participate in the study.
Who cannot join
- Individuals younger than 18 or older than 65 years, those whose physical or cognitive health status made participation in the study process unsuitable, those not caring for an individual diagnosed with lung cancer, those with hearing loss or any health problem that could prevent participation in the music-listening intervention, and those who did not volunteer to participate were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music on Anxiety and Caregiver Burden in Family Caregivers of Lung Cancer Patients: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of a 7-day self-selected music intervention on caregiver burden and anxiety among first-degree family caregivers of patients with lung cancer. Fifty caregivers were randomized to an intervention group (n=25), who listened to selected music for 30 minutes daily for 7 days, or a control group (n=25), who received routine care. Caregiver burden and anxiety were assessed before and after the intervention. The intervention was associated with significant reductions in caregiver burden and trait anxiety, suggesting that self-selected music may be a feasible, low-cost complementary nursing intervention for family caregivers.
- Conditions
- Anxiety, Evidence-based Practice, Caregiver Burden, Nursing, Lung Cancer
- Being tested
- Music intervention
- Medical subject headings
- Anxiety Disorders, Caregiver Burden, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Caregivers in the intervention group were presented with a music list prepared by the researchers in line with the recommendations of the Turkish Music Research and Promotion Group, consisting of pieces in the Rast makam (Turkish classical music mode). Participants were asked to select a piece from the list according to their own preference.
Participants were asked to listen to their chosen piece of music through headphones, uninterrupted, for 30 minutes daily at the same time each day, for seven consecutive days. No additional music intervention was applied to participants during the intervention period, and the selected piece was not changed throughout the seven-day application period. Adherence was monitored through a self-reported daily listening log completed by participants and verified through a daily phone call/reminder from the researcher.
| Study group | Role | What they receive |
|---|---|---|
| music intervention group | Experimental | Caregivers in the intervention group were presented with a music list prepared by the researchers in line with the recommendations of the Turkish Music Research and Promotion Group, consisting of pieces in the Rast makam (Turkish classical music modes). Participants were asked to select a piece from the list according to their own preference.
Participants were asked to listen to their chosen piece of music through headphones, uninterrupted, for 30 minutes daily at the same time each day, for seven consecutive days. No additional music intervention was applied to participants during the intervention period, and the selected piece was not changed throughout the seven-day application period. Receives: Behavioral: Music intervention |
| control group | No intervention | No music-listening intervention was applied to caregivers in the control group, and participants continued to receive routine care processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Zarit Caregiver Burden Interview (ZCBI) The ZCBI was developed by Zarit, Reever, and Bach-Peterson (1980); its Turkish validity and reliability study was conducted by İnci and Erdem (2008). The scale consists of 22 items assessing the physical, psychological, social, and economic difficulties experienced by caregivers. Rated on a five-point Likert scale, responses range from "never" to "nearly always" and are scored from 0 to 4.
The total score obtainable from the scale ranges from 0 to 88. A total score of 0-20 is considered little or no burden, 21-40 moderate burden, 41-60 severe burden, and 61-88 very severe burden. Higher scores indicate greater perceived caregiver burden. The Cronbach's alpha internal consistency coefficient of the Turkish version was reported as 0.95 in the adaptation study
Measured: From enrollment to the end of intervention for seven days
Anxiety
State-Trait Anxiety Inventory (STAI) The STAI was developed by Spielberger, Gorsuch, and Lushene (1970); its Turkish validity and reliability study was conducted by Öner and Le Compte (1985). The inventory consists of two subscales assessing state and trait anxiety levels. Each subscale consists of 20 items rated on a four-point Likert-type scale.
The State Anxiety Scale (SAS) assesses the level of anxiety experienced by an individual at a specific moment and under existing circumstances, whereas the Trait Anxiety Scale (TAS) assesses an individual's general anxiety proneness independent of the situation. Scores obtainable from each subscale range from 20 to 80, with higher scores indicating higher anxiety levels. The reliability coefficients of the inventory have been reported to range from 0.83 to 0.87
Measured: From enrollment to the end of intervention for seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start10 Feb 2025
- Primary completion15 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Celik, Izmir Bakircay University
- Investigators
- Ayşegül ÇELİK, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847138
- Sponsor's protocol ID
- MU
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Anxiety and Caregiver Burden in Family Caregivers of Lung Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07847138
- Acronym / sponsor ID
- MU
- Conditions
- Anxiety, Evidence-based Practice, Caregiver Burden, Nursing, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 Sep 2026 (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 randomized controlled trial evaluated the effects of a 7-day self-selected music intervention on caregiver burden and anxiety among first-degree family caregivers of patients with lung cancer. Fifty caregivers were randomized to an intervention group (n=25), who listened to selected music for 30 minutes daily for 7 days, or a control group (n=25), who received routine care. Caregiver burden and anxiety were assessed before and after the intervention. The intervention was associated with significant reductions in caregiver burden and trait anxiety, suggesting that self-selected music may be a feasible, low-cost complementary nursing intervention for family caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music intervention group | Experimental | Behavioral: Music interventionCaregivers in the intervention group were presented with a music list prepared by the researchers in line with the recommendations of the Turkish Music Research and Promotion Group, consisting of pieces in the Rast makam (Turkish classical music modes). Participants were asked to select a piece from the list according to their own preference. Participants were asked to listen to their chosen piece of music through headphones, uninterrupted, for 30 minutes daily at the same time each day, for seven consecutive days. No additional music intervention was applied to participants during the intervention period, and the selected piece was not changed throughout the seven-day application period. |
| control group | No intervention | –No music-listening intervention was applied to caregivers in the control group, and participants continued to receive routine care processes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included first-degree family members aged between 18 and 65 years who were caring for an individual diagnosed with lung cancer, who had been providing care for at least six months, who had no condition preventing communication or any hearing impairment, and who volunteered to participate in the study.
Key exclusion criteria (1 listed)
- Individuals younger than 18 or older than 65 years, those whose physical or cognitive health status made participation in the study process unsuitable, those not caring for an individual diagnosed with lung cancer, those with hearing loss or any health problem that could prevent participation in the music-listening intervention, and those who did not volunteer to participate were excluded from 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 interventionCaregivers in the intervention group were presented with a music list prepared by the researchers in line with the recommendations of the Turkish Music Research and Promotion Group, consisting of pieces in the Rast makam (Turkish classical music mode). Participants were asked to select a piece from the list according to their own preference. Participants were asked to listen to their chosen piece of music through headphones, uninterrupted, for 30 minutes daily at the same time each day, for seven consecutive days. No additional music intervention was applied to participants during the intervention period, and the selected piece was not changed throughout the seven-day application period. Adherence was monitored through a self-reported daily listening log completed by participants and verified through a daily phone call/reminder from the researcher. | Behavioural | music intervention group |
Primary outcome
Caregiver Burden
Time frame: From enrollment to the end of intervention for seven days
Zarit Caregiver Burden Interview (ZCBI) The ZCBI was developed by Zarit, Reever, and Bach-Peterson (1980); its Turkish validity and reliability study was conducted by İnci and Erdem (2008). The scale consists of 22 items assessing the physical, psychological, social, and economic difficulties experienced by caregivers. Rated on a five-point Likert scale, responses range from "never" to "nearly always" and are scored from 0 to 4. The total score obtainable from the scale ranges from 0 to 88. A total score of 0-20 is considered little or no burden, 21-40 moderate burden, 41-60 severe burden, and 61-88 very severe burden. Higher scores indicate greater perceived caregiver burden. The Cronbach's alpha internal consistency coefficient of the Turkish version was reported as 0.95 in the adaptation study
Anxiety
Time frame: From enrollment to the end of intervention for seven days
State-Trait Anxiety Inventory (STAI) The STAI was developed by Spielberger, Gorsuch, and Lushene (1970); its Turkish validity and reliability study was conducted by Öner and Le Compte (1985). The inventory consists of two subscales assessing state and trait anxiety levels. Each subscale consists of 20 items rated on a four-point Likert-type scale. The State Anxiety Scale (SAS) assesses the level of anxiety experienced by an individual at a specific moment and under existing circumstances, whereas the Trait Anxiety Scale (TAS) assesses an individual's general anxiety proneness independent of the situation. Scores obtainable from each subscale range from 20 to 80, with higher scores indicating higher anxiety levels. The reliability coefficients of the inventory have been reported to range from 0.83 to 0.87
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy.
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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.
Ayşegül ÇELİK principal investigator
Izmir Bakircay 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 intervention in people with Anxiety and Evidence-based Practice, 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 1 inclusion and 1 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 29 Sep 2026. 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?
Caregiver Burden (time frame: From enrollment to the end of intervention for seven days). The study lists 2 primary outcomes in all. 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 29 Sep 2026.