Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101953
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-10-21
Brief Title:
The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
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:
The goal of this observational study is to explore the impact of a 12-week online knowledge-sharing program focusing on stress management psychological resilience and interoception in university students who face various stressors The primary questions it aims to answer are
How does participating in the online program influence students understanding and management of stress
Can engaging in this program enhance students resilience in the face of academic and life challenges
Does the program improve students interoception skills helping them recognize and manage internal bodily sensations and emotions more effectively
Participants will be asked to
Attend weekly sessions covering topics such as stress its sources stages diseases related to stress coping methods psychological resilience and interoception
Engage in discussions self-reflection and practical exercises
Share their experiences and insights
Complete assessments to measure their perceived stress level resilience and interoceptive awareness
Researchers will compare the group that participates in the program with a control group to determine if the program significantly improves stress management enhances psychological resilience and bolsters interoception skills among university students
How does participating in the online program influence students understanding and management of stress
Can engaging in this program enhance students resilience in the face of academic and life challenges
Does the program improve students interoception skills helping them recognize and manage internal bodily sensations and emotions more effectively
Participants will be asked to
Attend weekly sessions covering topics such as stress its sources stages diseases related to stress coping methods psychological resilience and interoception
Engage in discussions self-reflection and practical exercises
Share their experiences and insights
Complete assessments to measure their perceived stress level resilience and interoceptive awareness
Researchers will compare the group that participates in the program with a control group to determine if the program significantly improves stress management enhances psychological resilience and bolsters interoception skills among university students
Detailed Description:
Participants and Sampling The study sample consisted of university students enrolled in the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences particularly those taking the Stress Coping Methods course The determination of the sample size was guided by a rigorous statistical approach employing G Power for power analysis Following this randomization was performed to create both a control group and an intervention group The inclusion criteria required participants to be at least 18 years old studying at a university in Turkey and having Turkish as their native language The sole exclusion criterion was the presence of any psychiatric diagnosis ensuring the homogeneity of the sample
Study Procedure The intervention program stretching over 12 weeks was based on the Stress Coping Mechanisms lecture derived from various resources such as Pendleton and Schultz-Khron 2001 Brown et al 2019 and Reitz et al 2020 Delivered by a seasoned practitioner with over 20 years of expertise in stress coping education the program consisted of three hours per week The curriculum was thoughtfully structured to ensure a comprehensive understanding of stress its sources stages diseases associated with stress coping strategies psychological resilience and interoception
The online knowledge-sharing format encouraged interactivity with participants engaging in discussions self-reflection and practical exercises As part of the learning process students were encouraged to conduct self-inquiries and present their findings to the class The program aimed to provide students with a profound understanding of stress emphasizing the critical role of psychological resilience and interoception in effective stress management and overall well-being
Statistical Analysis The statistical analysis was carried out using SPSS v26 software The Kolmogorov-Smirnov test was used to assess the normality of all variables Descriptive statistics were applied including frequency percentage mean minimum maximum and standard deviation for categorical and numerical variables To evaluate differences between categorical variables the chi-square test was employed The Wilcoxon signed-rank test was used to compare baseline and final scores while the Mann-Whitney U test compared the results between the control and intervention groups The significance level was set at p005 Detailed statistical analyses were guided by a predefined analytical plan that encompassed both primary and secondary objectives as outlined in the study protocol Quality assurance data validation and other registry-specific procedures were followed in line with best practices ensuring data integrity and the accuracy of the results Site monitoring and auditing data checks for data quality and source data verification were integral parts of the quality assurance plan Additionally a data dictionary containing detailed variable descriptions as well as Standard Operating Procedures for various registry operations was meticulously maintained Further components included sample size assessment a plan for addressing missing data and a comprehensive statistical analysis plan to address the primary and secondary objectives as specified in the study protocol
Study Procedure The intervention program stretching over 12 weeks was based on the Stress Coping Mechanisms lecture derived from various resources such as Pendleton and Schultz-Khron 2001 Brown et al 2019 and Reitz et al 2020 Delivered by a seasoned practitioner with over 20 years of expertise in stress coping education the program consisted of three hours per week The curriculum was thoughtfully structured to ensure a comprehensive understanding of stress its sources stages diseases associated with stress coping strategies psychological resilience and interoception
The online knowledge-sharing format encouraged interactivity with participants engaging in discussions self-reflection and practical exercises As part of the learning process students were encouraged to conduct self-inquiries and present their findings to the class The program aimed to provide students with a profound understanding of stress emphasizing the critical role of psychological resilience and interoception in effective stress management and overall well-being
Statistical Analysis The statistical analysis was carried out using SPSS v26 software The Kolmogorov-Smirnov test was used to assess the normality of all variables Descriptive statistics were applied including frequency percentage mean minimum maximum and standard deviation for categorical and numerical variables To evaluate differences between categorical variables the chi-square test was employed The Wilcoxon signed-rank test was used to compare baseline and final scores while the Mann-Whitney U test compared the results between the control and intervention groups The significance level was set at p005 Detailed statistical analyses were guided by a predefined analytical plan that encompassed both primary and secondary objectives as outlined in the study protocol Quality assurance data validation and other registry-specific procedures were followed in line with best practices ensuring data integrity and the accuracy of the results Site monitoring and auditing data checks for data quality and source data verification were integral parts of the quality assurance plan Additionally a data dictionary containing detailed variable descriptions as well as Standard Operating Procedures for various registry operations was meticulously maintained Further components included sample size assessment a plan for addressing missing data and a comprehensive statistical analysis plan to address the primary and secondary objectives as specified in the study protocol
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-68552689-000-00003048522 | OTHER | Hacettepe University Ethics Comission | None |