Effect of EMG, RESP, and TEMP Biofeedback Training to Reduce Anxiety Among Undergraduate Students
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Karachi
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Effective Biofeedback Training
Study Overview
Brief Summary
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).
Detailed Description
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):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 21 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Biofeedback Group
- The training consists of a total of 8 sessions for every individual with 2 sessions per week over the duration of 4 weeks. Each session will be approximately of 1 to 1.30 hour.
- Subjects will be given clear instructions to not to use chocolate, coffee, tea and cocoa drinks at least 3 hours before the training session.
- Since it is suggested that Anxiety tends to change with time so we might consider a one-month pretreatment measure as well as a just before treatment measure. That way we can be sure if our baseline is stable or not.
- Baseline session: Subject will be asked to sit quietly for 15 minutes and their breathing rate, skin temperature and muscle tension using EMG will be measure without giving any intervention.
- Subjects will then be given biofeedback training gradually to control their breathing rate, relaxed their muscle activity and temperature through RESP biofeedback, assisted EMG biofeedback and TEMP biofeedback, from the 1st session till their 8th Session.
Intervention: Biofeedback (Device)
Active Control Group
Active Control: Writing Sessions The 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. For example, in Session 1, we may ask the Subjects to write about how they will use their time. Similarly, we will ask the subject to give more detail and write briefly about the given control condition in session 2 and session 3. At the end of three writing session, we will measure their EMG, RESP and TEMP to compare with the Biofeedback training group.
Intervention: Writing Sessions (Other)
Outcomes
Primary Outcomes
Effective Biofeedback Training
Time Frame: 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
Secondary Outcomes
- Electromyography (EMG)(4 Weeks)
- Respiratory Rate(4 Weeks)
- Temperature(4 Weeks)
Investigators
Shamoon Noushad
University of Karachi
University of Karachi