Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05508919
Status:
UNKNOWN
Last Update Posted:
2022-08-19
First Post:
2022-06-28
Brief Title:
Effect of Biofeedback Training to Reduce Anxiety
Sponsor:
University of Karachi
Organization:
University of Karachi
Study Overview
Official Title:
Effect of EMG RESP and TEMP Biofeedback Training to Reduce Anxiety Among Undergraduate Students
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
For this study we will be using the Alive Pioneer with the GP8 Amp GP8 Amp can record ECG Heart Rate EMG for muscle tension Hand Temperature and Skin conductance Subjects in this group will get EMG RESP and TEMP biofeedback intervention training
Electromyography Biofeedback EMG The surface EMG disposable sticky sensors will be attached to the bicep or flexor muscle The ground sensor will be attached to subjects fingertips to read the heart rate A conductive paste such as Ten20 Conductive Paste can be used to improve the connection on hairy areas The electrodes can be placed one right after another Attach the white black and green lines from the GP8 Amp to the disposable electrodes in order to see the EMG signals
Respiration Biofeedback RESP In this training the GP8 Amp Reparation belt will be used The Respiration Belt is placed around the abdomen or chest to measure the subject breathing As the subject breathe the belt stretches slightly and this stretch near the middle of the belt is measured The respiration data is shown as a yellow line in the breath pacer area in the Alive Bottom Graphs The yellow respiration line shows how the subject breathing affects hisher heart rate and smoothness
Temperature Biofeedback TEMP As suggested that temperature in the hand increases when one get relax Using GP8 Amp we can teach the subjects to increase their hand temperature dramatically The temperature sensor is attached to the GP8 Amp in the mini-USB slot nearest the 4 leads The other end of temperature sensor will be placed in the subject finger using one of the skin conductance Velcro finger straps to hold the temperature sensor in place It will take 30 seconds to 1 minute for temperature to calibrate until the temperature measured stops increasing then the training begins
The sequence of the biofeedback training sessions is given below
1 The training consists of a total of 8 sessions for every individual with 2 sessions per week over the duration of 4 weeks
2 Each session will be approximately of 1 to 130 hour
3 Subjects will be given clear instructions to not to use chocolate coffee tea and cocoa drinks at least 3 hours before the training session
4 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
5 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
6 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
The control intervention
In control intervention 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
At the end of biofeedback training and writing sessions the participants of both groups will also be asked to again fill the State-Trait Anxiety Inventory -STAI scale
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
For this study we will be using the Alive Pioneer with the GP8 Amp GP8 Amp can record ECG Heart Rate EMG for muscle tension Hand Temperature and Skin conductance Subjects in this group will get EMG RESP and TEMP biofeedback intervention training
Electromyography Biofeedback EMG The surface EMG disposable sticky sensors will be attached to the bicep or flexor muscle The ground sensor will be attached to subjects fingertips to read the heart rate A conductive paste such as Ten20 Conductive Paste can be used to improve the connection on hairy areas The electrodes can be placed one right after another Attach the white black and green lines from the GP8 Amp to the disposable electrodes in order to see the EMG signals
Respiration Biofeedback RESP In this training the GP8 Amp Reparation belt will be used The Respiration Belt is placed around the abdomen or chest to measure the subject breathing As the subject breathe the belt stretches slightly and this stretch near the middle of the belt is measured The respiration data is shown as a yellow line in the breath pacer area in the Alive Bottom Graphs The yellow respiration line shows how the subject breathing affects hisher heart rate and smoothness
Temperature Biofeedback TEMP As suggested that temperature in the hand increases when one get relax Using GP8 Amp we can teach the subjects to increase their hand temperature dramatically The temperature sensor is attached to the GP8 Amp in the mini-USB slot nearest the 4 leads The other end of temperature sensor will be placed in the subject finger using one of the skin conductance Velcro finger straps to hold the temperature sensor in place It will take 30 seconds to 1 minute for temperature to calibrate until the temperature measured stops increasing then the training begins
The sequence of the biofeedback training sessions is given below
1 The training consists of a total of 8 sessions for every individual with 2 sessions per week over the duration of 4 weeks
2 Each session will be approximately of 1 to 130 hour
3 Subjects will be given clear instructions to not to use chocolate coffee tea and cocoa drinks at least 3 hours before the training session
4 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
5 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
6 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
The control intervention
In control intervention 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
At the end of biofeedback training and writing sessions the participants of both groups will also be asked to again fill the State-Trait Anxiety Inventory -STAI scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None