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临床试验/CTRI/2024/09/073617
CTRI/2024/09/073617尚未招募2 期

Effectiveness of Benson’s Relaxation Technique with Arm Ergometer to Improve Lung Efficiency, Pain Intensity and Quality of Life in Patients After Coronary Artery Bypass Grafting

Barvi Bandral1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

The eligibility of the participants will be taken on the basis of the inclusion criteria of this research study. The informed consent will be taken from 60 subjects that will be selected according to the inclusion criteria.

Pre-Operative Procedure:- All the patients who will be involved in the study will be given consent form for their willingness to participate in the study.

The demographic data of the patient will be taken pre-operatively.

The patients will be instructed and taught about the Bensons relaxation technique that contains all the breathing techniques.

The patients will be taught about arm ergometer and its significance.

Post-Operative Procedure:- Post-operative program will be started after the patient will be extubated from the mechanical ventilator.

The patient must be hemodinamically stable from the first day till the day of discharge from CTVS at least for 7 days after the surgery (post-operatively)

The pain levels of the patient will be assessed using Numeric Pain Rating Scale (NPRS) after surgery at day 1 and day 7.

The patient’s inspiratory and expiratory capacity will be measured using 3-ball incentive spirometer and quality of life will be assessed using SF-36 questionnaire on day 1 and then on day 7.

Treatment Protocol:

Warm-up exercises: Breathing exercises (Diaphragmatic breathing and pursed lip breathing) followed by gentle movements of upper limb (shoulder shrugs, elbow movements, wrist pumps).

To initiate the arm ergometer post-operative day 1, we will follow the FITT principle for exercise prescription as follows:

Frequency: We will give two sessions per day.

Intensity: The intensity will be low to moderate with no resistance. Monitor heart rate (aim for 40-50% of heart rate reserve) and ensure it stays within the prescribed limits.

Time: We will begin with exercise using arm ergometer as tolerable to the patient.

Type: We will use an arm ergometer for cardiovascular exercise and emphasize controlled and smooth movements to avoid excessive strain. We will include both forward and backward pedalling as well as proper body positioning.

To initiate the Benson Relaxation Response, we will take the following steps:

Take a comfortable seat and sit quietly.

Close your eyes.

Let all of your muscles relax fully.

Inhale via your nose. Pay attention to how you breathe. Say the word "ONE" to yourself in silence as you exhale. Take a breath, for instance, IN and OUT, "ONE": IN and OUT, "ONE": etc. Inhale smoothly and instinctively.

Keep going for ten to twenty minutes. To check the time, you can open your eyes, but avoid setting an alarm. After you are done, take a few minutes to sit quietly, first with your eyes closed and then with them open. Keep down your feet for a few minutes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Subjects who underwent CABG in the hospital.
  • Subjects with ejection fraction ranging from 50% and more.
  • Subjects that will be medically and clinically stable after surgery will be taken.
  • Subjects willing to participate in the study.
  • Subjects able to provide verbal and written consent.

排除标准

  • Subjects who had developed hemodynamic complications (e.g. lung congestion, subjects on intra-aortic balloon, preoperative myocardial infarction).
  • Subjects with ejection fraction less than 50%.
  • Post-operative renal failure.
  • Post-operative arrhythmia needed for a pacemaker.
  • Post-operative mechanical ventilation (more than 24 hours).
  • Previous history of cardiac surgery.

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: 7 days

Incentive Spirometer

时间窗: 7 days

36-Item Short Form Survey (SF-36)

时间窗: 7 days

次要结局

  • Incentive Spirometer(2nd day, 5th day)

研究者

发起方
Barvi Bandral
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Barvi Bandral

Mahatma Gandhi University of Medical Sciences and Technology, Jaipur

研究点 (1)

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