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临床试验/NCT05570773
NCT05570773已完成不适用

Effects of Peer Support and Progressive Relaxation Exercises on Sleep Quality and Anxiety in Midwifery Students During COVID-19 Pandemic: A Randomized Controlled Trial

Cukurova University2 个研究点 分布在 2 个国家目标入组 104 人开始时间: 2021年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
State and Trait Anxiety Inventory

研究概览

简要总结

The effect of peer support and progressive relaxation exercise programs on midwifery students' sleep and anxiety levels in the COVID-19 pandemic was investigated in the present research. One hundred and four subjects were found eligible for the study according to the inclusion criteria, and they were grouped into three: the peer support program group (PSP) (n=34), the progressive relaxation exercise group (PRE) (n=35), and control group (n=35). The PRE group was given an online relaxation exercise program. The PSP group was given an online peer support program. The data collection tools included a descriptive data form, State-Trait Anxiety Inventory (STAI-I-II), and Pittsburgh Sleep Quality Index (PSQI). The scores of the groups that they obtained from the pre-test application of the STAI-I and PSQI did not yield a statistically significant difference. The scores that PRE and PSP groups obtained from the post-test application of the STAI-I and PSQI were lower than the score that was obtained by the control group on the post-test application of the measures, and difference was evaluated to be significant. Although the mechanisms of action of these two methods are different, it has been observed that they have similar effects in improving anxiety levels and sleep quality.

详细描述

This is a randomized, controlled intervention trial. It was carried out according to CONSORT guidelines between February 12 and March 28, 2021 with students who were studying midwifery at a state university.

Randomization Three hundred and sixty students from the midwifery department made up the population of the study, and the sample consisted of three hundred and thirteen students that agreed to join the study. We excluded some subjects from the study according to the exclusion criteria. The remaining one hundred and forty-four subjects were randomly divided into groups as PRE, PSP, and controls through randomization by assigning consecutive numbers to them via computer software (https://www.randomizer.org/). Accordingly, forty-eight students were assigned to the PRE group, forty-eight to the PSP group, and forty-eight to the control group. After the randomization step, 8 students from the PRE group, 10 from the PSP group, and 12 from the control group, who did not want to continue, were excluded from the study. During the follow-up period, 3 students from the PRE group and 2 students from the PSP group were excluded because they did not achieve 80% attendance. Since five subjects (two, PRE group; two, PSP group; one, control group) were unavailable during the data analysis stage, their final measurements could not be made, and therefore they were excluded. The study was completed with a total of 104 students, including 35 in the PRE group, 34 in the PSP group, and 35 in the control group. First, all 3 groups filled out the questionnaires as a pre-test application. At the end of 30 days, the groups filled out the questionnaires as a post-test. It took approximately 10-15 minutes to fill out the questionnaires.

Intervention groups PRE group The importance of the exercise and how it should be done were explained by the researcher Mixed teaching methods, including lecturing, demonstration, question-answer, and discussion were, used as education methods. The sessions were carried out online by a researcher who is an expert in the field of PRE for 30 minutes every day between 21:00 and 21:30 before bedtime for 30 days.

Steps of progressive relaxation exercises: This progressive relaxation technique developed by Jacobson is one of the easiest to learn and practice. PRE is a holistic approach based on the controlled, voluntary, regular, and successive active contraction and passive relaxation of major muscle groups. The person is asked to wear comfortable clothes, relax as much as possible, and breathe slowly and deeply. This technique, which can be applied sitting or lying down, can also be performed with music to contribute to the relaxation of the individual.

The education begins with diaphragmatic breathing exercises and continues with PRE. In this exercise, the patient positions one of his/her hand on his/her chest and the other on the mid-abdomen, and then told to breathe in slowly and deeply through the nose, counting to 4, hold the air counting to 4 again, and exhale by pursing lips while exhaling. In diaphragmatic breathing, the abdomen is expected to be inflated as much as possible while breathing in through the nose. While performing the exercise, the sensory, visual, and tactile stimuli given to the patient are gradually reduced and made difficult. The exercise is repeated 2-3 times, and then the patient is allowed to rest between the sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • did not have sleep apnea,
  • did not musculoskeletal disease
  • did not cardio-pulmonary disease
  • did not psychiatric disease
  • did not use drugs, cigarettes, alcohol
  • SAI score of >36 (anxiety)
  • PSQI score of >5 (poor sleep quality)

排除标准

  • Clinical diagnosis of sleep apnea
  • musculoskeletal disease
  • cardio-pulmonary disease
  • psychiatric disease
  • history of drugs, smoking, and alcohol
  • SAI score of ≤36 (no anxiety),
  • PSQI score of ≤5 (good sleep quality)

结局指标

主要结局

State and Trait Anxiety Inventory

时间窗: 16 weeks

questionnaire

次要结局

  • Pittsburgh Sleep Quality Index(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif DAĞLI

Lecturer Doctor

Cukurova University

研究点 (2)

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