## Protocol Section
### Identification Module
**NCT ID:** NCT06438016

**Brief Title:** Stress Management Training for Nursing Professionals in a Tertiary Care Center in Nepal

**Official Title:** Exploring the Efficiency of Stress Management Training Programs in Reducing Stress Levels Within Nursing Professionals in a Tertiary Care Center in Nepal

#### Organization Study ID Info
**ID:** 205/2024
#### Organization
**Class:** OTHER
**Full Name:** Dhulikhel Hospital
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dhulikhel Hospital

#### Responsible Party

**Investigator Affiliation:** Dhulikhel Hospital

**Investigator Full Name:** Rebecca Makaju Shrestha

**Investigator Title:** Psychologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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. 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Mental Health

**Keywords:**

- Stress; Stress Management; Nursing; Nepal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Treatment group will obtain stress management whilst the control will not. The control group will obtain stress management one month upon study completion

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 86

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Stress Management Training

**Label:** Stress Management Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stress Management Group

**Description:** 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.

**Name:** Stress Management Training

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Depression Anxiety Stress Scale - 21

**Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention.

**Description:** 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).

**Measure:** Perceived Stress Scale

**Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention.

### Eligibility Module

**Eligibility Criteria:** 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)

**Maximum Age:** 65 Years

**Minimum Age:** 8 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rebecca.m.shrestha@gmail.com

**Name:** Rebecca Makaju Shrestha, Psychology

**Phone:** 9820114531

**Role:** CONTACT

**Contact 2:**

**Email:** subasnashrestha@gmail.com

**Name:** Subasna Shrestha, MN

**Phone:** 9849294785

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dhulikhel

**Contacts:**

***Contact 1:***

- **Email:** rebecca.m.shrestha@gmail.com

- **Name:** Rebecca Shrestha, MClinPsych

- **Phone:** 9820114531

- **Role:** CONTACT

***Contact 2:***

- **Email:** subasnashrestha@gmail.com

- **Name:** Subasna Shrestha, MN

- **Phone:** 9849294785

- **Role:** CONTACT

***Contact 3:***

- **Name:** Rebecca Shrestha, MClinPsych

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Subasna Shrestha, MN

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Nepal

**Facility:** Dhulikhel Hospital

**State:** Kavrepalanchowk

**Zip:** 45200

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 25031113

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**PMID:** 31916468

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**PMID:** 31912984

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**PMID:** 25703040

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## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
