Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06390254
Other study ID # RBNI-PWB-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 25, 2024
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Cairo University
Contact Mostafa Shaban, Phd
Phone 00966565644617
Email mostafa.shaban2020@cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the impact of a resilience-enhancing nursing intervention on the psychological well-being of older adults living in the community. Participants will benefit from individualized nursing support designed to bolster their resilience and coping skills. This intervention will be customized to meet personal requirements and provided in a nurturing setting. Engaging in this study could result in enhanced well-being and life quality. Although some minor discomforts may arise during assessments or interventions, the confidentiality and rights of the participants will be rigorously safeguarded.


Description:

Background: As the global population ages, there is an increasing need to address the psychological well-being of older adults living independently in the community. Previous research has highlighted the importance of resilience in maintaining mental health and coping with life stressors among older individuals. However, there is limited evidence on the effectiveness of specific interventions aimed at enhancing resilience in this population. Objective: The primary objective of this study is to evaluate the effectiveness of a resilience-building nursing intervention in improving the psychological well-being of community-dwelling older adults. Secondary objectives include assessing the impact of the intervention on factors such as social support, coping strategies, and quality of life. Study Design: This study will employ a randomized controlled trial design. Participants will be randomly assigned to either the intervention group, receiving the resilience-building nursing intervention, or the control group, receiving standard care. Intervention: The resilience-building nursing intervention will consist of individualized sessions delivered by trained nurses. The intervention will focus on enhancing participants' resilience through skill-building exercises, cognitive-behavioral techniques, and psychoeducation. Sessions will be tailored to address the unique needs and challenges of each participant. Participants: The target population for this study includes community-dwelling older adults aged 65 and above who are experiencing mild to moderate psychological distress. Participants will be recruited from community centers, senior living facilities, and primary care clinics. Procedures: Participants will undergo baseline assessments to collect demographic information and baseline measures of psychological well-being. Those assigned to the intervention group will receive the resilience-building nursing intervention over a specified period, with follow-up assessments conducted at regular intervals to evaluate outcomes. Outcome Measures: Primary outcome measures will include changes in psychological well-being, as assessed by standardized scales such as the Geriatric Depression Scale and the Psychological Well-being Scale. Secondary outcome measures will include social support, coping strategies, and quality of life. Statistical Analysis: Data will be analyzed using appropriate statistical methods, including t-tests, chi-square tests, and linear regression. Sample size calculations will ensure adequate power to detect meaningful differences between groups. Ethical Considerations: This study will adhere to ethical principles outlined in the Declaration of Helsinki. Informed consent will be obtained from all participants, and measures will be taken to ensure participant confidentiality and privacy. Data Management: Data will be collected using secure electronic data capture systems and stored in accordance with institutional guidelines and data protection regulations.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date June 30, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Adults aged 60 years and older. - Individuals living in the community. - Mild to moderate psychological distress. Exclusion Criteria: - Severe cognitive impairment or dementia. - Significant medical or psychiatric comorbidities that could impede participation in the intervention. - Inability to understand and communicate in the language used for the intervention materials. - Concurrent participation in another research study involving psychological interventions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Resilience-Enhancing Nursing Suppor
The resilience-building nursing intervention in this study is a multifaceted approach aimed at enhancing the psychological well-being and coping abilities of community-dwelling older adults. Unlike standard care, which typically focuses on symptom management, this intervention emphasizes proactive strategies to promote resilience and improve overall quality of life.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (6)

Chow KM, Tang FWK, Tang WPY, Leung AWY. Resilience-building module for undergraduate nursing students: A mixed-methods evaluation. Nurse Educ Pract. 2020 Nov;49:102912. doi: 10.1016/j.nepr.2020.102912. Epub 2020 Nov 6. — View Citation

Cleary M, Kornhaber R, Thapa DK, West S, Visentin D. The effectiveness of interventions to improve resilience among health professionals: A systematic review. Nurse Educ Today. 2018 Dec;71:247-263. doi: 10.1016/j.nedt.2018.10.002. Epub 2018 Oct 11. — View Citation

Henshall C, Davey Z, Srikesavan C, Hart L, Butcher D, Cipriani A. Implementation of a Web-Based Resilience Enhancement Training for Nurses: Pilot Randomized Controlled Trial. J Med Internet Res. 2023 Feb 14;25:e43771. doi: 10.2196/43771. — View Citation

Jayakrishnan K, Baruah A, Kumar P, Javeth A. Scales and Interventions for Resilience among Treatment-Seeking Patients with Depression: A Systematic Review. J Caring Sci. 2023 May 21;12(2):84-93. doi: 10.34172/jcs.2023.31964. eCollection 2023 Jun. — View Citation

Wu Y, Dai Z, Jing S, Liu X, Zhang L, Liu X, Ren T, Fu J, Chen X, Xiao W, Wang H, Huang Y, Wang W, Gu X, Ma L, Zhang S, Yu Y, Li L, Han Z, Su X, Qiao Y. Prevalence and influencing factors of PTSD symptoms among healthcare workers: A multicenter cross-secti — View Citation

Zahid N, Martins RS, Zahid W, Khalid W, Azam I, Bhamani SS, Ahmad K, Jabbar A, Shamim MS, Khan RJ, Javed G, Bari E, Asad N, Enam SA. Resilience and its associated factors in brain tumor patients in Karachi, Pakistan: An analytical cross-sectional study. P — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological Well-being Assessment The main outcome measure of this study is the alteration in psychological well-being among participants, gauged using standardized the Psychological Well-being Scale (PWB) Psychological well-being will be assessed at baseline, prior to the intervention, and at follow-up assessments conducted at 1 months post-intervention.
See also
  Status Clinical Trial Phase
Completed NCT04285164 - Normative Values of the Berg Balance Scale and Timed Up and Go Test