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临床试验/NCT05807295
NCT05807295尚未招募不适用

The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.

Gazi University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
coping with stress

研究概览

简要总结

This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks

详细描述

In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.

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 (Participant, 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

  • •The child has received cancer treatment for at least two months,
  • •Those who have internet access on their smartphone or computer
  • •Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)

排除标准

  • •Those whose children/caregivers are in the terminal period,
  • •Those whose child/caregiver has not received chemotherapy treatment,
  • •Those who take medication for anxiety or use one of the complementary medicine approaches.

研究组 & 干预措施

Control group

No Intervention

the group that did not receive any training

Intervention

Experimental

caregivers receiving a relaxation program

干预措施: Relaxation Program (Other)

结局指标

主要结局

coping with stress

时间窗: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)

The scale is a 23-item self-report measure of anxiety using a 5-point Likert-type scale. The scale does not have a cut-off point. The higher the score obtained from the scale, the better the coping is determined.

Anxiety

时间窗: Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)

The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

次要结局

未报告次要终点

研究者

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

Çiğdem Sarı Öztürk

Gazi University

Gazi University

研究点 (1)

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