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临床试验/NCT07828028
NCT07828028已完成不适用

The Effect of the 4-7-8 Breathing Technique Applied During Chemotherapy on Anxiety, Symptom Burden, and Sleep Quality

Malatya Turgut Ozal University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
State Anxiety Level

研究概览

简要总结

This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.

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
None

入排标准

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

入选标准

  • Requirements include being 18 years of age or older;
  • not being in the third stage of the disease;
  • having no communication barriers, mental or physical impairments, or visual or hearing impairments;
  • being able to speak Turkish and agreeing to participate.

排除标准

  • Those who do not agree to participate in the study,
  • Those under the age of 18

研究组 & 干预措施

Intervention Group

Experimental

Participants receiving the 3rd cycle of chemotherapy will be assigned to the intervention group. Participants will receive routine nursing care and standard chemotherapy care in addition to the 4-7-8 breathing technique. The breathing technique will be individually taught face-to-face by the researcher before chemotherapy. Participants will perform the technique twice daily, in the morning and evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality.

干预措施: 4-7-8 breathing technique (Behavioral)

Intervention Group

Experimental

Participants receiving the 3rd cycle of chemotherapy will be assigned to the intervention group. Participants will receive routine nursing care and standard chemotherapy care in addition to the 4-7-8 breathing technique. The breathing technique will be individually taught face-to-face by the researcher before chemotherapy. Participants will perform the technique twice daily, in the morning and evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality.

干预措施: routine care (Other)

Control Group

Active Comparator

Participants receiving the 3rd cycle of chemotherapy will be assigned to the control group. Participants will receive routine nursing care and standard chemotherapy care according to usual clinical practice. The 4-7-8 breathing technique will not be provided during the 21-day study period. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality.

干预措施: routine care (Other)

结局指标

主要结局

State Anxiety Level

时间窗: Baseline and Day 21

State anxiety level was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S). The STAI-S consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. State anxiety was assessed at baseline and on Day 21.

Sleep Quality

时间窗: Baseline and Day 21

Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep disturbances, with higher total scores indicating poorer sleep quality. Sleep quality was assessed at baseline and on Day 21.

Chemotherapy Symptom Burden

时间窗: Baseline and Day 21

Chemotherapy symptom burden was assessed using the Edmonton Symptom Assessment System (ESAS). The severity of symptoms was rated on a 0-10 numerical scale, with higher scores indicating greater symptom severity. Chemotherapy symptom burden was assessed at baseline and on Day 21.

次要结局

未报告次要终点

研究者

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

beyzanur ulupınar

Master's Student

Malatya Turgut Ozal University

研究点 (1)

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