Effect of Biofeedback Training to Reduce Anxiety

NCT05508919 | Unknown DMC

• 1 other identifier: BTRA2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Keywords

Biofeedback Training; Anxiety; Nursing Students; EMG; Respiration; Temperature

Outcome Measures

Primary Outcomes (1)

• Effective Biofeedback Training

  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

  4 Weeks

Secondary Outcomes (3)

• Electromyography (EMG)

  4 Weeks

• Respiratory Rate

  4 Weeks

• Temperature

  4 Weeks

Study Arms (2)

Biofeedback Group

EXPERIMENTAL

* 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.

Device: Biofeedback

Active Control Group

ACTIVE COMPARATOR

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.

Other: Writing Sessions

Interventions

Biofeedback DEVICE

EMG, RESP, and TEMP Biofeedback Training

Biofeedback Group

Writing Sessions OTHER

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

Active Control Group

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Karachi: lead
• Advanced Education & Research Center: collaborator

Study Sites (1)

Koohi Goth Women Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (7)

• Chalo P, Pereira A, Batista P, Sancho L. Brief Biofeedback Intervention on Anxious Freshman University Students. Appl Psychophysiol Biofeedback. 2017 Sep;42(3):163-168. doi: 10.1007/s10484-017-9361-5.

  PMID: 28527121 RESULT

• Ratanasiripong P, Ratanasiripong N, Kathalae D. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial. ISRN Nurs. 2012;2012:827972. doi: 10.5402/2012/827972. Epub 2012 Jun 28.

  PMID: 22811932 RESULT

• Gholami Tahsini Z, Makvand Hosseini S, Kianersi F, Rashn S, Majdara E. Biofeedback-Aided Relaxation Training Helps Emotional Disturbances in Undergraduate Students Before Examination. Appl Psychophysiol Biofeedback. 2017 Dec;42(4):299-307. doi: 10.1007/s10484-017-9375-z.

  PMID: 28761991 RESULT

• McAusland L, Addington J. Biofeedback to treat anxiety in young people at clinical high risk for developing psychosis. Early Interv Psychiatry. 2018 Aug;12(4):694-701. doi: 10.1111/eip.12368. Epub 2016 Aug 29.

  PMID: 27573093 RESULT

• Niles AN, Haltom KE, Mulvenna CM, Lieberman MD, Stanton AL. Randomized controlled trial of expressive writing for psychological and physical health: the moderating role of emotional expressivity. Anxiety Stress Coping. 2014 Jan;27(1):1-17. doi: 10.1080/10615806.2013.802308. Epub 2013 Jun 6.

  PMID: 23742666 RESULT

• Schoenberg PL, David AS. Biofeedback for psychiatric disorders: a systematic review. Appl Psychophysiol Biofeedback. 2014 Jun;39(2):109-35. doi: 10.1007/s10484-014-9246-9.

  PMID: 24806535 RESULT

• Prato CA, Yucha CB. Biofeedback-assisted relaxation training to decrease test anxiety in nursing students. Nurs Educ Perspect. 2013 Mar-Apr;34(2):76-81. doi: 10.5480/1536-5026-34.2.76.

  PMID: 23763019 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Respiratory Aspiration

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Shamoon Noushad, PhD

  University of Karachi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ujala Sajid, M.Sc.

CONTACT

03222183212; ujalasajid97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Karachi

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: August 19, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)