The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.
详细描述
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.
Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 [alpha], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.
The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older,
- •volunteering to participate in the study,
- •conscious and not having communication problems,
- •not taking any course on anxiety, tension, depression symptoms and coping with stress
排除标准
- •Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression) • Take another psychological relaxation course or training
研究组 & 干预措施
Intervention
Mindfulness-based breathing and music therapy
干预措施: Mindfulness (Other)
Control
No intervention has been made
结局指标
主要结局
Beck Depression Inventory
时间窗: at the end of week 1.
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
Psychological Well-Being Scale
时间窗: at the end of week 1
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Information Form
时间窗: Baseline
This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.
State Anxiety Inventory
时间窗: at the end of week 1
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
State Anxiety Inventory
时间窗: Baseline
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
Psychological Well-Being Scale
时间窗: baseline
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Beck Depression Inventory
时间窗: baseline
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
次要结局
未报告次要终点
研究者
DİLEK YILDIRIM
Assistant professor Dr.
Istanbul Aydın University