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临床试验/CTRI/2025/05/086577
CTRI/2025/05/086577尚未招募不适用

Effect of yoga-based breathing and relaxation regimen on preoperative anxiety and neurological biomarkers in neurosurgical patients: A prospective randomized controlled trial

Sanjay Gandhi Postgraduate Institute of Medical Sciences SGPGIMS Lucknow1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To determine the effect of a short-term yoga-based breathing regimen on preoperative anxiety, using the State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

Preoperative anxiety, affecting 17% to 89% of brain surgery patients, can result in longer hospital stays, depression, increased physical disability, reduced quality of life, and impaired cognitive functions. Conventional antianxiety drugs like opioids and benzodiazepines worsen the problem by causing hypoventilation and raising intracranial pressure. This has led to a focus on nonpharmacological interventions that avoid these adverse effects. Yoga is a promising therapeutic tool for managing physical, psychological, and psychosomatic disorders. Studies in cardiac surgery patients and breast cancer survivors have demonstrated the efficacy of yoga-based lifestyle programs and breathing exercises. Yoga has been linked to physiological and biochemical benefits.

This study explores the potential benefits of incorporating yoga-based breathing and relaxation techniques into the perioperative care of neurosurgical patients. We hypothesize that neurosurgical patients scheduled for elective supratentorial tumor excision who practice yoga-based breathing exercises for about five days preoperatively will experience reduced preoperative anxiety compared to those who do not. Research Question: Does a short-term yoga-based

breathing regimen reduce preoperative anxiety in neurosurgical patients compared to those who do not practice yoga? Primary Objective: To determine the effect of a short-term yoga-based breathing regimen on preoperative anxiety,

using the State-Trait Anxiety Inventory (STAI). Secondary Objective: To determine the impact of an extended yoga-based

breathing regimen, continued into the postoperative period, on neurological biomarkers such as glial fibrillary acidic protein (GFAP), neurofilament light (NfL), S100B and brain-derived neurotropic factor (BDNF), and to explore the feasibility and adherence of supervised tele-yoga sessions in perioperative care of neurosurgical patients. This prospective randomized controlled trial will be conducted on 80 patients (40 in each group) in the Neurosurgical wards of Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow. The study will include adult

patients (aged 18-65 years) scheduled for elective craniotomy and excision of supratentorial tumors under general anesthesia. The study will include ASA I or II patients who are conscious and oriented. Patients unwilling to consent, those

with significant mass effect or tumor-induced seizures, severe pulmonary or coronary artery disease, smoking or alcohol abuse, psychiatric disorders, emergency surgeries, and significant skeletal or joint disorders will be excluded. Group Y (Yoga) patients will receive yoga-based breathing and relaxation regimes for at least five days before surgery and Group C (Control) patients will not receive yoga interventions while receiving usual medical care. A night before surgery, anxiety scores (STAI) will be assessed in all the patients (Primary outcome). At six weeks of discharge, GFAP, NfL, S100B and BDNF will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA I or II adult patients (aged 18-65 years) of either sex
  • Conscious patients who are oriented to time, place, and person with GCS 15/15 scheduled for elective craniotomy and excision of supratentorial tumors under general anesthesia.

排除标准

  • Patient/patient attendants unwilling to give consent
  • Patients experiencing significant mass effect such as headache, nausea, vomiting, photophobia, drowsiness, or any other signs of raised intracranial pressure
  • Patients with motor sensory deficit
  • Patients with hearing or vision impairment
  • Patients with tumor-induced seizures who are uncontrolled on weight-appropriate antiepileptic medication
  • Severe pulmonary disorders i.e., restrictive or obstructive lung disease
  • Severe coronary artery disease or heart failure
  • Smoking or alcohol abuse
  • Psychiatric disorder
  • Emergency surgery
  • Patients with recurrent tumors for re-do surgery
  • Patients with significant skeletal or joint disorders hindering them from performing the relevant yoga postures/ techniques.

结局指标

主要结局

To determine the effect of a short-term yoga-based breathing regimen on preoperative anxiety, using the State-Trait Anxiety Inventory (STAI)

时间窗: Before surgery

次要结局

  • 1. To evaluate the impact of yoga-based breathing & relaxation practices, continued into the postoperative period, on serum biomarkers including GFAP (Glial Fibrillary Acidic Protein), NfL (Neurofilament Light), S100beta, & BDNF (Brain Derived Neurotropic Factor) at 6 weeks. 2. To explore the feasibility & adherence of supervised tele-yoga sessions in the perioperative care of neurosurgical patients.(6 weeks)

研究者

发起方
Sanjay Gandhi Postgraduate Institute of Medical Sciences SGPGIMS Lucknow
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nidhi Singh

Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow

研究点 (1)

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