The Effect of Benson Relaxation Exercises on Sleep Quality in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Sleep quality-Pittsburg Sleep Quality Index (PSQI)
研究概览
简要总结
The aim of this study is to investigate the effect of Benson Relaxation Exercises on sleep quality in hospitalized patients diagnosed with lung cancer. It is planned to be conducted as a randomized controlled trial.
Hypotheses of the Study H1: The sleep quality of lung cancer patients who undergo Benson relaxation exercises is statistically significantly better than that of patients who do not undergo such exercises.
H2: There is no significant difference in sleep quality between patients who undergo Benson relaxation exercises and those who do not.
详细描述
This study is planned to be conducted between September 2025 and June 2026 with patients receiving inpatient treatment at the chest ward of a state hospital in Turkey. Patients with lung cancer, pneumonia, type 2 respiratory failure, haemoptysis and tuberculosis receive inpatient treatment at this hospital. A total of 1,787 patients have been treated as inpatients at the hospital in the past year. Patients stay in single rooms. Patients do not engage in any activities other than medical treatment and care.
Participants
The research universe consists of 196 patients diagnosed with lung cancer who are undergoing inpatient treatment at the state hospital's chest clinic. Patients who are unconscious and unable to communicate will be excluded from the research. Randomisation will be applied to the number of patients to be obtained.
In the randomisation phase of the study, Statistical Analysis Software will be used to randomly assign patients. Patients will be randomly assigned to groups using this programme. Patients included in the study will be numbered according to their order of arrival and assigned to the intervention and control groups according to the order in the randomisation list. One of the researchers will be responsible for assigning patients to groups using the Statistical Analysis Software program. This researcher will not participate in the Benson exercises conducted with the patients. Since none of the researchers will know which patients are in the study group, the study will be conducted using a single-blind method. Accordingly, the study is planned to be terminated when a total of 60 patients, including 30 intervention and 30 control groups, are reached.
After reaching the sample size of 60, a power analysis is planned to be performed using the GPower 3.1 programme at a 95% confidence interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
experimental and control groups
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and over,
- •Have been diagnosed with lung cancer and be receiving inpatient treatment,
- •Be conscious and able to communicate,
- •Agree to participate in breathing exercises during the study,
- •Score above 5 on the PSQI,
- •Sign a written informed consent form.
排除标准
- •Patients under 18 years of age,
- •Those with additional mental or cognitive disorders,
- •Those with physiological barriers to performing breathing exercises,
- •Those unable to complete the programme during the study period,
- •Those with a PSQI score above 5,
- •Those who violated the study protocol,
- •. Those with an oxygen saturation value below 90,
- •Those scoring above 5 on the Visual Pain Scale,
- •Those who have previously practised yoga or meditation,
- •Patients with haemoptysis,
- •Patients taking any anxiolytic or hypnotic medication.
- •During the 15 days of Benson relaxation exercise, patients in both the intervention and control groups will not be allowed to perform the exercise if their O2 saturation and pain level changes meet the exclusion criteria.
结局指标
主要结局
Sleep quality-Pittsburg Sleep Quality Index (PSQI)
时间窗: up to 6 months
The Pittsburgh Sleep Quality Index (PSQI)
次要结局
未报告次要终点
研究者
elçin babaoğlu
Asst. Dr. (Psychiatric Nursing)
Uskudar University