跳至主要内容
临床试验/CTRI/2018/04/012999
CTRI/2018/04/012999招募中2 期

Effect of Psychoneurobics (Meditation technique) on level of Anxiety in Patients Undergoing Cataract Surgery.

Shubhra Agrawal Gupta1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月25日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Amsterdam Preoperative Anxiety and Information Scale(APAIS) score

研究概览

简要总结

Anxiety is an unpleasant emotional experience that involves feelings of tension, apprehension, nervousness and high autonomic activity. Major life changes are among factors that cause anxiety, and one of these changes is surgery.

Cataract surgery is one of the most common operations performed and one of the safest and most effective. Most cataract surgery is now performed under local anesthesia on a day-care basis. As patients are fully conscious during the procedure, it is important that they remain still. Everyone is anxious when facing cataract surgery because of the fear of unknown.

 Anxiety is expected in pre-operative patients, the incidence of pre- operative anxiety is reported to range from 11-80% among patients. Preoperative anxiety is a challenging concept in the preoperative care of patients. Most patients awaiting elective surgery experience anxiety and it is widely accepted as an expected response. If unrecognized, prolonged anxiety creates stress which may subsequently harm the patient and delay recovery.

 When surgery is recommended to an individual, the proposed operation, regardless of its extent, is perceived by the patient to be a major procedure. Besides that, patients will think about the recovery state and operative effect for their daily living, and also a fear about death and dying.3

 A variety of therapeutic approaches have been made to reducing the anxiety before the operation, like music therapy, meditation, or spiritual therapy. Spirituality approach can be used to reduce patient’s anxiety, especially when they are facing a medical-surgical procedure.

 Role of Psycho Neurobics****– Psycho-neurobics is a meditation technique for effective healing through complete involvement of mind, body and soul. It encapsulated the supporting aspects of Rajyoga and Mudra healing. As Aerobics is the exercises of pumping air into lungs, neurobics is the exercises of creating bio electrical impulses in neuro cells / neuro transmitters by various motor or mental activities; similarly Psycho Neurobics is the exercises of transferring Spiritual Energy in neuro cells by connecting Psyche (Mind) to the Supreme Source of Spiritual Energy (God). Spirituality makes one feel the quietness. When calm, stress hormones will be reduced, so that the impact of stress hormones on wound healing can be minimized.

 Although meditation has been practiced for centuries, it is only recently that the effects of meditation have been studied more extensively within the scientific community. Modern science has acknowledged the role of psyche, thought and emotions in healthy and unhealthy response in the body. So the present study is designed to assess the effect of Psychoneurobics (Neurobic spa) on anxiety level of patients undergoing cataract surgery. As in clinical settings - in the preoperative phase - extensive questionnaires are not applicable. Therefore, it is important to have applicable screening instruments to assess preoperative anxiety. So Besides objectivity, reliability and validity, the applicability is essential which refers to brevity, clinical relevance, patients’ acceptance as well as a fast and simple analysis format.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Above 40 yrs of age 2)Having cataract 3)Either fee from hypertension and diabetes mellitus or Having controlled hypertension and diabetes mellitus.
  • Planned for SICS / Phaco-emulcification mode of surgery performed under Peribulbar anaesthesia(local anaesthesia) 5)Given consent.

排除标准

  • <40 yrs 2) Not willing to participate in study 3) Associated Ocular or Systemic co-morbidities and uncontrolled Diabetes mellitus and Hypertension.

结局指标

主要结局

Amsterdam Preoperative Anxiety and Information Scale(APAIS) score

时间窗: 1-Before intervention and cataract surgery | 2-After intervention and before cataract surgery

次要结局

  • Happiness score through happiness stress stethoscope,Blood pressure sugar, heart rate, respiratory rate.(1-Before intervention and cataract surgery)

研究者

发起方
Shubhra Agrawal Gupta
申办方类型
Other [self-sponsored]

研究点 (1)

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