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临床试验/NCT06746584
NCT06746584尚未招募不适用

Investigation of the Effect of Benson Relaxation Exercise on Anxiety and Sleep Quality in Inpatients in Psychiatric Service: a Randomized Controlled Study

Uskudar University0 个研究点目标入组 70 人开始时间: 2024年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
anxiety level -STAI Forms

研究概览

简要总结

This study was planned to investigate the effect of Benson Relaxation Exercise on anxiety and sleep quality in inpatients in psychiatric ward. The following hypothesis will be tested in the study.

H1: Anxiety level of the patients who underwent Benson relaxation exercise is lower than the patients who did not undergo Benson relaxation exercise.

H2: The sleep quality of patients who undergo Benson relaxation exercise is better than patients who do not undergo Benson relaxation exercise.

The study is designed as a single-blind, randomised controlled trial. The study will be conducted in four psychiatric wards of a private psychiatric hospital in Turkey between 18.11.2024-06.06.2025. Verbal and written informed consent will be obtained from participants or their legal guardians before assignment to study groups. The study will be conducted according to the CONSORT flow diagram (http://www.consort-statement.org/consort-statement/flow-diagram) (2010)

详细描述

The study will be conducted between 18.11.2024 and 06.06.2025 in four psychiatric wards of a private psychiatric hospital in Turkey. In this hospital, patients with schizophrenia, psychotic disorders, mood and anxiety disorders and substance use disorders receive inpatient treatment. In the last 1 year, a total of 350 patients received inpatient treatment in the hospital. Patients stay in single rooms in the clinics. Apart from medical treatment and care, patients participate in activities such as group activities, occupational hours and walking.

Participants The population of this study consisted of a total of 350 inpatients in psychiatric wards. Since patients diagnosed with psychotic disorder and schizophrenia have delusions and hallucinations, the effect of some instructions in the Benson relaxation technique on these symptoms cannot be known. Therefore, it was planned to exclude psychosis and schizophrenia patients with delusions and hallucinations from the study. In sample selection, State Anxiety Form I (STAI-I) / State Anxiety Form II (STAI-I) and Pittsburg Sleep Quality Index (PSQI) will be applied by the researchers to patients other than these diagnoses. In the literature, the mean score of the STAI I-II scale varies between 36 and 41. Scores between 20 and 39 indicate mild anxiety and 40-59 points indicate moderate anxiety . In the literature, PSQI total score has a value between 0-21. A total scale score of 5 and above indicates poor sleep quality. Since the differences in anxiety and sleep quality levels will affect group homogeneity, patients with a total score of 20-59 points (mild and moderate) from STAI-I-II and patients with a score above 5 from PSQI will constitute the sample of the study. Accordingly, the inclusion criteria were planned as follows: Patients aged 18 years and over, patients being treated for mood, anxiety, obsessive-compulsive disorder and substance use disorder, patients with STAI I-II scores between 20 and 59, patients with PSQI score above 5. Exclusion criteria were patients under 18 years of age, patients with psychotic disorders with hallucinations and delusions, patients with schizophrenia, STAI I-II score below 20 and above 59, PSQI score below 5. Patients who meet the inclusion criteria will be divided into two groups as intervention and control group by single blind randomisation. 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 the order of arrival and placed in the intervention and control groups according to the order in the randomisation list.

It is planned that one of the researchers will assign the patients to the groups using the Statistical Analysis Software programme. This investigator will not participate in the Benson exercises with the patients. Since none of the investigators knew which patients participated in the study group, the study was conducted using single blinding method.

Accordingly, it is planned to finalise the study when a total of 70 patients, 35 in the intervention group and 35 in the control group, are reached. After reaching a sample of 70 people, it is planned to perform the power analysis of the study with GPower 3.1 programme at 95% confidence interval.

Measurement In this study, the patient descriptive information form, STAI-II and PSQI forms created by the researchers will be used. Patient Descriptive Information Form: This form developed by the researchers includes 8 number of questions to determine sociodemographic characteristics such as age, gender, educational status, duration of illness, number of hospitalisations, family history of illness, age at onset of illness and psychotropic drugs used. The State-Trait Anxiety Inventory Anxiety (STAI I-II): This scale was developed by Spielberger et.al. (1983) and its Turkish validity and reliability was performed by Öner and Le Compte (1983). The scale measures anxiety in both healthy and clinical populations. The scale consists of two parts: State Anxiety Inventory (STAI I) and Trait Anxiety Inventory (STAI II). STAI I determines how the individual feels at a certain time and under certain conditions, while STAI II determines how the individual feels regardless of the situation and conditions in which the individual is located. Alpha reliability coefficient of the scale was determined between 0.94-0.96 for STAI I and 0.83-0.87 for STAI II. Each scale consists of two types of statements with 20 items. Direct statements describe negative emotions and inverted statements describe positive emotions. The reversed statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 in STAI I and items 21, 26, 27, 30, 33, 36 and 39 in STAI II. In STAI I, the answers were evaluated with a 4-point scale (not at all, a little, a lot, completely). In STAI II, participants' responses were measured with a 4-point scale (never, sometimes, very often, almost always). The total score value obtained from both scales is between 20 and 80. It has also been shown that people with higher scores on the STAI scales are more prone to experience anxiety. The scale has been translated into 48 languages as of 2011. The STAI I AND II have been shown to have excellent psychometric properties with good reliability and validity. Pittsburgh Sleep Quality Index -PSQI (The Pittsburgh Sleep Quality Index): The Turkish validity and reliability of this scale developed by Buysse et al. (1989) was performed by Ağargün et al. (1996) The PSQI provides a quantitative measure of sleep quality that helps to define good and bad sleep. The PSQI contains a total of 24 questions. 19 of these questions are self-assessment questions. 5 questions are answered by the individual's spouse or a friend. These 5 questions are used only for clinical information and do not participate in the evaluation. Question 19 of the self-assessment questions is related to the presence of a roommate or spouse and is not taken into account in determining the total and component scores of the scale. Self-assessment questions include various factors related to sleep quality. These questions determine sleep duration, sleep latency, and the frequency and severity of special problems related to sleep. The 18 scored items were grouped into 7 component scores. Some of the components consist of a single item, while others are obtained by grouping several items. Each item is evaluated with a score between 0-3. The sum of the seven component scores gives the total PSQI score. The total score has a value between 0-21. A high total scale score indicates poor sleep quality. A total PSQI score of 5 and above indicates poor sleep quality. Data collection tools will be applied to both intervention and control groups by the researchers before starting BRT. At the end of 2 weeks, immediately after the completion of all exercises, final measurements will be made with the same data collection tools to both groups. At the end of 2 weeks, after the Benson exercises are completed, follow-up measurements will be performed with the same measurement tools in both groups for follow-up evaluation in the 3rd week. While BRT is applied to the intervention group, no application will be made to the patients in the control group. Measurement tools will be applied to the control group at the same time intervals as the patients in the intervention group.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and over,
  • patients being treated for mood, anxiety, obsessive-compulsive disorder and substance use disorder,
  • patients with STAI I-II scores between 20 and 59, patients with PSQI score above 5.

排除标准

  • Patients under 18 years of age,
  • patients with psychotic disorders with hallucinations and delusions, patients with schizophrenia,
  • patients with STAI I-II score below 20 and above 59, patients with PSQI score below 5.

结局指标

主要结局

anxiety level -STAI Forms

时间窗: up to 6 months

anxiety level, the STAI-II forms

次要结局

  • Sleep quality-Pittsburg Sleep Quality Index (PSQI)(up to 6 months)

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

elçin babaoğlu

Asst. Dr. (Psychiatric Nursing)

Uskudar University

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