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临床试验/NCT07542691
NCT07542691尚未招募不适用

Effect of Respiratory Physiotherapy and Progressive Muscle Relaxation Exercises on Dyspnea, Anxiety, Hemodynamic Status and Delirium Symptoms After Cardiac Surgery: A Randomized Controlled Trial

Istanbul Aydın University0 个研究点目标入组 116 人开始时间: 2026年5月1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
发起方
入组人数
116
主要终点
Dyspnea (Modified Borg Scale)

研究概览

简要总结

This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over three consecutive days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.

详细描述

This study is designed as a randomized controlled trial to investigate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients following cardiac surgery. A total of 116 adult patients who have undergone cardiac surgery will be recruited and randomly allocated into two groups: an intervention group and a control group.

The intervention group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, together with progressive muscle relaxation exercises, in addition to routine postoperative care. These interventions will be applied for 30 minutes per day over three consecutive days in the postoperative period. The control group will receive only routine postoperative care and standard cardiac rehabilitation procedures.

Outcome measures will include dyspnea assessed using the Modified Borg Scale, anxiety assessed using the State-Trait Anxiety Inventory, hemodynamic parameters including blood pressure, heart rate, respiratory rate, and oxygen saturation obtained from routine vital sign monitoring, and delirium symptoms assessed using the Nursing Delirium Screening Scale. Data will be collected at baseline and after the intervention period.

Inclusion criteria include patients aged 18 years and older who have undergone cardiac surgery and are able to participate in the interventions. Patients with severe orthopedic limitations, communication barriers, or medical contraindications to the interventions will be excluded. Participants may withdraw from the study at any time, and all procedures will be conducted in accordance with ethical standards and patient safety principles.

Randomization will be performed using a computer-based randomization method, and participants will be assigned to groups in a 1:1 ratio. Statistical analysis will be conducted using appropriate parametric and non-parametric tests, with a significance level set at p < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

入选标准

  • Patients aged 18-80 years who have undergone cardiac surgery
  • Hemodynamically stable patients
  • Patients able to cooperate and follow instructions
  • Patients with postoperative dyspnea
  • Patients who provide written informed consent

排除标准

  • Patients with severe cognitive impairment or inability to cooperate
  • Patients with neurological or psychiatric disorders affecting participation
  • Patients requiring mechanical ventilation for prolonged periods
  • Patients with unstable hemodynamic status
  • Patients with contraindications to respiratory physiotherapy or exercise
  • Patients who refuse to participate

研究组 & 干预措施

Respiratory Physiotherapy + PMR

Experimental

Participants in this group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, combined with progressive muscle relaxation exercises in addition to routine postoperative care. The intervention will be applied for 30 minutes per day over three consecutive days following cardiac surgery.

干预措施: Respiratory Physiotherapy (Other)

Respiratory Physiotherapy + PMR

Experimental

Participants in this group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, combined with progressive muscle relaxation exercises in addition to routine postoperative care. The intervention will be applied for 30 minutes per day over three consecutive days following cardiac surgery.

干预措施: Progressive Muscle Relaxation (Other)

Routine Care

Active Comparator

Participants in this group will receive routine postoperative care and standard cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.

干预措施: Routine Care (Other)

结局指标

主要结局

Dyspnea (Modified Borg Scale)

时间窗: Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)

Dyspnea severity will be assessed using the Modified Borg Scale (MBS). The scale ranges from 0 (no dyspnea) to 10 (maximal dyspnea). Higher scores indicate greater perceived breathlessness. Measurements will be performed by a trained assessor under standardized conditions.

次要结局

未报告次要终点

研究者

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

FATMA ÇAVDARCI

Associate Professor

Istanbul Aydın University

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