NCT07847138

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    From enrollment to the end of intervention for seven days

Study Arms (2)

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.

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

Interventions

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.

music intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersCaregiver BurdenLung Neoplasms

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehaviorRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ayşegül ÇELİK

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC. PROF.

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

February 10, 2025

Primary Completion

April 15, 2025

Study Completion

April 30, 2025

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy.

Locations