Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546163
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Heart Rate Variability Biofeedback on College Students With Disordered Eating
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial study is to test the heart rate variability biofeedback training in female college students with eating disorders and compare the results between intervention and control group The main questions it aims to answer are
How does heart rate variability biofeedback HRVB training impact behaviors related to eating disorders EDs and the perceived stress associated with these behaviors
What difference are observed in the quality of life and stress responses between individuals trained in HRVB protocol and those in the wait list condition
Does HRVB training enhance heart resilience and improve the ability to cope with psychosocial stressors in young women with eating disorders compared to those in the wait list condition
Participants will be asked to do the following steps
Baseline heart rate variability assessment and completion of the baseline questionnaire
HRVB training session and two weeks of at-home HRVB practice-10 minutes daily intervention group
Post-intervention questionnaire completion and heart rate variability assessment
Optional interview for intervention group and HRVB training session for control group
Researchers will compare the results of intervention group with control group to see if the participants improve in levels of emotional health quality of life and resilience
How does heart rate variability biofeedback HRVB training impact behaviors related to eating disorders EDs and the perceived stress associated with these behaviors
What difference are observed in the quality of life and stress responses between individuals trained in HRVB protocol and those in the wait list condition
Does HRVB training enhance heart resilience and improve the ability to cope with psychosocial stressors in young women with eating disorders compared to those in the wait list condition
Participants will be asked to do the following steps
Baseline heart rate variability assessment and completion of the baseline questionnaire
HRVB training session and two weeks of at-home HRVB practice-10 minutes daily intervention group
Post-intervention questionnaire completion and heart rate variability assessment
Optional interview for intervention group and HRVB training session for control group
Researchers will compare the results of intervention group with control group to see if the participants improve in levels of emotional health quality of life and resilience
Detailed Description:
This study is a randomized controlled trial aimed at examining the effect of Heart Rate Variability Biofeedback HRVB in female college students with eating disorders The primary objective of the study is to determine whether HRVB can positively impact the psychosocial health and well-being
Participants are the female college students aged 18 and above The number of 30 female college students will participate in the study and they will be randomly assigned to either the HRVB intervention group or the control group 15 for each group Total Duration of the study will be 2 weeks from the time of enrollment to completion
Participants are required to visit the lab twice - for baseline and final data collection They undergo initial assessments before any intervention including a 3- minute baseline HRV assessment Using the HeartMath Pro Plus device equipped with an ear or finger sensor and questionnaires about mood states stress levels and eating behaviors The intervention group will receive instructions to practice HRVB and practice it at home for 10 minutes daily over a two-week period totaling approximately 140 minutes They will receive a routine callstextsemail from the research team as a reminder to practice HRVB sessions as well Final Data Collection will be done at the end of the two-week intervention period for both groups Participants from the intervention group will have the option to participate in a brief interview to provide feedback on their experiences with the HRVB intervention and those in control group will receive HRVB training
All procedure is designed to prioritize participant comfort and privacy with informed consent being a crucial part of the enrollment process
Participants are the female college students aged 18 and above The number of 30 female college students will participate in the study and they will be randomly assigned to either the HRVB intervention group or the control group 15 for each group Total Duration of the study will be 2 weeks from the time of enrollment to completion
Participants are required to visit the lab twice - for baseline and final data collection They undergo initial assessments before any intervention including a 3- minute baseline HRV assessment Using the HeartMath Pro Plus device equipped with an ear or finger sensor and questionnaires about mood states stress levels and eating behaviors The intervention group will receive instructions to practice HRVB and practice it at home for 10 minutes daily over a two-week period totaling approximately 140 minutes They will receive a routine callstextsemail from the research team as a reminder to practice HRVB sessions as well Final Data Collection will be done at the end of the two-week intervention period for both groups Participants from the intervention group will have the option to participate in a brief interview to provide feedback on their experiences with the HRVB intervention and those in control group will receive HRVB training
All procedure is designed to prioritize participant comfort and privacy with informed consent being a crucial part of the enrollment process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None