The Effect of Music on Anxiety and Caregiver Burden in Family Caregivers of Lung Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Caregiver Burden
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
music intervention group
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.
干预措施: Music intervention (Behavioral)
control group
No music-listening intervention was applied to caregivers in the control group, and participants continued to receive routine care processes
结局指标
主要结局
Caregiver Burden
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Aysegul Celik
ASSOC. PROF.
Izmir Bakircay University
研究点 (1)
标识符
- NCT 编号
- NCT07847138
- 其他研究编号
- MU
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data will not be shared to protect participant privacy.