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临床试验/NCT05508919
NCT05508919Unknown不适用

Effect of EMG, RESP, and TEMP Biofeedback Training to Reduce Anxiety Among Undergraduate Students

University of Karachi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Effective Biofeedback Training

研究概览

简要总结

This study is planned to investigate the effectiveness of EMG, RESP, and TEMP Biofeedback Training to reduce symptoms of anxiety among the nursing students from one school, and to determine whether biofeedback training is associated to relax the minds and bodies of the anxious nursing students to cope with the distressing situation. Study subjects meeting the eligibility criteria will be randomized into two groups using randomly generated numbers: the Biofeedback training group and Control group. Biofeedback training will be used as an intervention vs the control. All the study subjects providing the consent to participate will be made to complete the study questionnaires (Demographic, Screening for Anxiety using the State-Trait Anxiety Inventory -STAI) at baseline and at post-intervention (after 4 weeks).

详细描述

Study Design:

This study will be conducted as a randomized control trial using subjects from one nursing school. Study subjects meeting the eligibility criteria will be randomized into two groups; the Biofeedback training group receiving EMG, RESP, and TEMP Biofeedback Training, and the Control group in which subjects will be asked to take three 20-minute writing sessions and write about the given control topic about their daily events of the past week. All the study subjects providing the consent to participate will be made to complete the study questionnaires (Demographic, Screening for Anxiety using the State-Trait Anxiety Inventory -STAI6, 7) at baseline and at post-intervention (after 4 weeks).

Study participants will be recruited from the School of Nursing, Koohi Goth Women Hospital, Karachi-Pakistan. Our targeted population will be students from diverse ethnicity and will be considered eligible for participation if they indicated to have anxiety in the pre-screening using the anxiety scale. Students will be invited to take part in the study through advertisement representation on the notice board of the institute. Written informed consent will be obtained from each enrolled subject after providing detail regarding the objectives, duration, and purpose of the study.

Interventions:

The experimental intervention (EMG, RESP, and TEMP Biofeedback):

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 21 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subject must not have any evidence of any metastatic disease.
  • Subject must be able to properly write and speak Urdu or English Language.
  • Subject must be a first- or second-year student.
  • Subject should have high anxiety that will be assessed using the State-Trait Anxiety Inventory-STAI.

排除标准

  • Subjects with any history of anxiolytic, antidepressant or other psychiatric medications will be excluded.
  • Subjects with any codified psychiatric disorder will be excluded.
  • Subjects who smoke or used alcohol will be excluded.
  • Subjects who received any structured psychological intervention, psychotherapy or biofeedback or relaxation training will be excluded.

结局指标

主要结局

Effective Biofeedback Training

时间窗: 4 Weeks

Biofeedback will be demonstrated as a possible effective and useful technique in helping individuals with anxiety over the duration of training of 4 weeks using he State-Trait Anxiety Inventory -STAI at baseline and post-intervention

次要结局

  • Electromyography (EMG)(4 Weeks)
  • Respiratory Rate(4 Weeks)
  • Temperature(4 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shamoon Noushad

University of Karachi

University of Karachi

研究点 (1)

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