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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06438016
Other study ID # 205/2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2024
Est. completion date September 30, 2024

Study information

Verified date May 2024
Source Dhulikhel Hospital
Contact Rebecca Makaju Shrestha, Psychology
Phone 9820114531
Email rebecca.m.shrestha@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if stress management programs can help alleviate existing and prevent future symptoms of stress in nursing professionals working in a tertiary care center in Nepal. Researchers will compare the treatment group (exposed to stress management training) to the control group (not exposed to stress management training) to see if 1. Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal. 2. To compare the pre and post training stress levels among participants of intervention and control group Participants will Fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale before either being exposed to a 4-session stress management training (treatment group) or not being exposed to such training (control). All participants (both groups) will fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale for pre-post comparative measure.


Description:

This study will aim to explore the effectiveness of a stress management program in nursing professionals in a community teaching hospital in Nepal. A 4-day stress management training program will be conducted and pre and post-training stress levels will be measured using the Perceived Stress Scale (PSS) and the Stress-Subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) one week prior to and after the training program. This experimental pre-post double arm study will involve 86 participants - all nursing staff from the Dhulikhel Hospital. Participants will be divided into 2 groups - treatment and control. The treatment group will be further divided into 2 groups of 20-25. The stress management training program will be held across 4 weeks with both groups receiving one training course each week (eg. Week 1 - session 1; Week 2 - session 2). Both questionnaires will be distributed again to both groups, 1 month after the last stress management session (1 - month follow up) .The control group whilst not being subjected to the Stress management training during the study period, will obtain the training upon study completion.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 86
Est. completion date September 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 8 Years to 65 Years
Eligibility Inclusion Criteria: - Nurses employed at the Dhulikhel Hospital - Minimum one year work experience - Minimum qualification certificate level of nursing - Fluent in spoken and written English Exclusion Criteria: - Nurses with the post of nurse manager and above - Nursing Students - History having undergone stress management training in the past - Absent for one or more sessions - Incidence of a major stressful/critical life event during the study (e.g., divorce, death, and other critical events)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stress Management Training
The intervention will comprise of 4 sessions delivered over 4 weeks. The training session will be structured as follows: Session 1 - Psychoeducation relating to stress and its effects. Session 2 - Behavioral techniques to cope with stress 1, Session 3 - Cognitive techniques to cope with stress and Session 4- Behavioral techniques to cope with stress. Both verbal and written means will be used to provide this training.

Locations

Country Name City State
Nepal Dhulikhel Hospital Dhulikhel Kavrepalanchowk

Sponsors (1)

Lead Sponsor Collaborator
Dhulikhel Hospital

Country where clinical trial is conducted

Nepal, 

References & Publications (22)

Alkhawaldeh JMA, Soh KL, Mukhtar FBM, Peng OC, Anshasi HA. Stress management interventions for intensive and critical care nurses: A systematic review. Nurs Crit Care. 2020 Mar;25(2):84-92. doi: 10.1111/nicc.12489. Epub 2019 Dec 15. — View Citation

Behzadi S, Alizadeh Z, Samani NK, Ghasemi A, Fereidouni Z, Rostami K. Effect of stress management on job stress of intensive care unit nurses in hospitals affiliated to the University of Medical Sciences. Archivos Venezolanos de Farmacología y Terapéutica. 2021;40(8):824-7.

Chaabane S, Chaabna K, Bhagat S, Abraham A, Doraiswamy S, Mamtani R, Cheema S. Perceived stress, stressors, and coping strategies among nursing students in the Middle East and North Africa: an overview of systematic reviews. Syst Rev. 2021 May 5;10(1):136. doi: 10.1186/s13643-021-01691-9. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Ducharme F, Dubé V, Lévesque L, Saulnier D, Giroux F. An online stress management training program as a supportive nursing intervention for family caregivers of an elderly person. Canadian Journal of Nursing Informatics. 2011 Jun;6(2):1-9.

Dutton S, Kozachik SL. Evaluating the Outcomes of a Web-Based Stress Management Program for Nurses and Nursing Assistants. Worldviews Evid Based Nurs. 2020 Feb;17(1):32-38. doi: 10.1111/wvn.12417. Epub 2020 Jan 8. — View Citation

Edwards D, Burnard P. A systematic review of stress and stress management interventions for mental health nurses. J Adv Nurs. 2003 Apr;42(2):169-200. doi: 10.1046/j.1365-2648.2003.02600.x. — View Citation

Hakim RM, Walton LM, Schwartz JJ, Futrell SM, Zaaeed N, Raigangar VL. Nepali Version of the Ten-Item Perceived Stress Scale: Translation and Validation Study for Bhutanese Refugees. In2023 Combined Sections Meeting (CSM) 2023 Feb 25. APTA.

Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9. — View Citation

Izdebski Z, Kozakiewicz A, Bialorudzki M, Dec-Pietrowska J, Mazur J. Occupational Burnout in Healthcare Workers, Stress and Other Symptoms of Work Overload during the COVID-19 Pandemic in Poland. Int J Environ Res Public Health. 2023 Jan 30;20(3):2428. doi: 10.3390/ijerph20032428. — View Citation

Kumar N, Jin Y. Impact of nurses' emotional labour on job stress and emotional exhaustion amid COVID-19: The role of instrumental support and coaching leadership as moderators. J Nurs Manag. 2022 Oct;30(7):2620-2632. doi: 10.1111/jonm.13818. Epub 2022 Oct 11. — View Citation

Lary A, Borimnejad L, Mardani-Hamooleh M. The Impact of a Stress Management Program on the Stress Response of Nurses in Neonatal Intensive Care Units: A Quasi-Experimental Study. J Perinat Neonatal Nurs. 2019 Apr/Jun;33(2):189-195. doi: 10.1097/JPN.0000000000000396. — View Citation

Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Mimura C, Griffiths P. The effectiveness of current approaches to workplace stress management in the nursing profession: an evidence based literature review. Occup Environ Med. 2003 Jan;60(1):10-5. doi: 10.1136/oem.60.1.10. — View Citation

Pahlavanzadeh S, Asgari Z, Alimohammadi N. Effects of stress management program on the quality of nursing care and intensive care unit nurses. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):213-8. doi: 10.4103/1735-9066.180376. — View Citation

Pahlevani M, Ebrahimi M, Radmehr S, Amini F, Bahraminasab M, Yazdani M. Effectiveness of stress management training on the psychological well-being of the nurses. J Med Life. 2015;8(Spec Iss 4):313-318. — View Citation

Sailaxmi G, Lalitha K. Impact of a stress management program on stress perception of nurses working with psychiatric patients. Asian J Psychiatr. 2015 Apr;14:42-5. doi: 10.1016/j.ajp.2015.01.002. Epub 2015 Feb 7. — View Citation

Thapa DK, Visentin D, Kornhaber R, Cleary M. Psychometric properties of the Nepali language version of the Depression Anxiety Stress Scales (DASS-21). Nurs Open. 2022 Nov;9(6):2608-2617. doi: 10.1002/nop2.959. Epub 2021 Jun 23. — View Citation

Woo T, Ho R, Tang A, Tam W. Global prevalence of burnout symptoms among nurses: A systematic review and meta-analysis. J Psychiatr Res. 2020 Apr;123:9-20. doi: 10.1016/j.jpsychires.2019.12.015. Epub 2020 Jan 22. — View Citation

Yazdani M, Rezaei S, Pahlavanzadeh S. The effectiveness of stress management training program on depression, anxiety and stress of the nursing students. Iran J Nurs Midwifery Res. 2010 Fall;15(4):208-15. — View Citation

Zanon C, Brenner RE, Baptista MN, Vogel DL, Rubin M, Al-Darmaki FR, Goncalves M, Heath PJ, Liao HY, Mackenzie CS, Topkaya N, Wade NG, Zlati A. Examining the Dimensionality, Reliability, and Invariance of the Depression, Anxiety, and Stress Scale-21 (DASS-21) Across Eight Countries. Assessment. 2021 Sep;28(6):1531-1544. doi: 10.1177/1073191119887449. Epub 2020 Jan 9. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Anxiety Stress Scale - 21 The DASS-21 is a 21-item tool measuring signs and symptoms of depression, anxiety and stress. The DASS-21 displays good to excellent internal consistency. Previous studies have reported a Cronbach's a ranging from 0.82 - 0.90 for Depression, .74 - .83 for Anxiety, and 82 - .87 for Stress. The DASS-21 has also been validated in Nepal with good reliability for each subscale, with Cronbach's alphas 0.79 for Anxiety, 0.91 for Stress, and 0.93 for Depression. One week prior to 4-week intervention, one week and one month post-intervention.
Primary Perceived Stress Scale The PSS displays good internal consistency with a Cronbach's a ranging from 0.74 - 0.91. A Nepali version of the PSS has also been evaluated yielding validity, strong overall internal consistency (Cronbach's a = 0.95) and inter-rater reliability (ICC = 0.96). One week prior to 4-week intervention, one week and one month post-intervention.
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