NCT06438016

Brief 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. 1.Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal.
  2. 2.To compare the pre and post training stress levels among participants of intervention and control group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 22, 2026

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

May 27, 2024

Last Update Submit

April 17, 2026

Conditions

Keywords

StressStress ManagementNursingNepal

Outcome Measures

Primary Outcomes (2)

  • 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 α 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. Each item is on a 4-pint likert scale with higher scores indicating heightened symptoms of Depression, Anxiety and Stress.

    One week prior to 4-week intervention, one week and one month post-intervention.

  • Perceived Stress Scale

    The PSS displays good internal consistency with a Cronbach's α ranging from 0.74 - 0.91. A Nepali version of the PSS has also been evaluated yielding validity, strong overall internal consistency (Cronbach's α = 0.95) and inter-rater reliability (ICC = 0.96). PSS scores can range from 0 to 56 with a higher score indicating higher levels of perceived stress.

    One week prior to 4-week intervention, one week and one month post-intervention.

Study Arms (2)

Stress Management Group

EXPERIMENTAL

Participants in this group will be provided with a demographic questionnaire, the DASS-21 and the PSS one week prior to and after the stress management training. The treatment group will be sub-divided into 2 groups of 20-25 participants and subjected to a 4-session stress management training program over the course of 4-weeks (one 40 minute session each week). The DASS and the PSS will be administered to this group one week and one month post completion of the final stress management training session.

Behavioral: Stress Management Training

Control Group

NO INTERVENTION

This control group will fill out the DASS-21 and PSS with the treatment group prior to the treatment group commencing stress management and will also fill out the DASS-21 and PSS upon completion of the treatment group's stress management training. This group will however not obtain stress management training during the study. Training will be provided upon study completion.

Interventions

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.

Stress Management Group

Eligibility Criteria

Age8 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses employed at the Dhulikhel Hospital
  • Minimum one year work experience
  • Minimum qualification certificate level of nursing
  • Fluent in spoken and written English

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Kavrepalanchowk, 45200, Nepal

Location

Related Publications (22)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25031113BACKGROUND
  • 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.

    PMID: 34161668BACKGROUND
  • 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.

    PMID: 31916468BACKGROUND
  • 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.

    PMID: 27186196BACKGROUND
  • 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.

    PMID: 33952346BACKGROUND
  • 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.

    PMID: 31912984BACKGROUND
  • 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.

    PMID: 12499451BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12670386BACKGROUND
  • 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.

    PMID: 25703040BACKGROUND
  • 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.

    PMID: 31021944BACKGROUND
  • 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.

    PMID: 31840391BACKGROUND
  • 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.

    PMID: 36767797BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 22049282BACKGROUND
  • 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.

    PMID: 28316750BACKGROUND
  • 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.

    PMID: 36181253BACKGROUND
  • 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.

    PMID: 32007680BACKGROUND
  • 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.

    PMID: 27969025BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Treatment group will obtain stress management whilst the control will not. The control group will obtain stress management one month upon study completion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

August 30, 2024

Primary Completion

October 30, 2024

Study Completion

November 30, 2024

Last Updated

April 22, 2026

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations