NCT06414629

Brief Summary

The goal of this research was to evaluate the effectiveness and implementation outcomes of the Simulation Based Mentorship Program (SBMP) which was implemented in four districts of Nepal. The main questions it aims to answer are:

  1. 1.What is the reach of the Simulation Based Mentorship Program?
  2. 2.What is the effect of Simulation Based Based Mentorship Program on knowledge, clinical skills, and confidence of nurses working in Birthing Centers of four district of Nepal?
  3. 3.How was the program adopted by the Birthing Centers?
  4. 4.How was the program implemented?
  5. 5.What is the perception regarding the maintenance of the program?
  6. 6.Infection prevention
  7. 7.Antenatal care and counseling
  8. 8.Essential care of labor and birth
  9. 9.Helping babies breathe
  10. 10.Bleeding after birth
  11. 11.Pre-eclampsia and eclampsia management
  12. 12.Postnatal care and counseling

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration 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

Study Start

First participant enrolled

November 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.2 years

First QC Date

May 6, 2024

Last Update Submit

May 9, 2024

Conditions

Keywords

SimulationMentorshipCapacity building

Outcome Measures

Primary Outcomes (1)

  • Knowledge, confidence and skills on seven modules

    The knowledge and confidence scores of intervention and control group's nurses in all seven modules were compared before and after the study. However, skills scores of seven modules were measured only in intervention group's nurses. The overall maximum obtainable score was 127 points for knowledge assessment, 210 points for confidence assessment, and 340 points for skills assessment. The scores obtained by the participants were expressed as percentage, and a mean score was calculated for each module. A score of 80% or more was considered to be appropriate. High scores indicated better outcome, and low scores indicated poor outcome.

    1 year

Study Arms (2)

Intervention Group/ Intervention Birthing Center

EXPERIMENTAL

The nurses working in the Intervention Birthing Centers received the Simulation Based Mentorship Program.

Other: Simulation Based Mentorship Program

Control Group/ Control Birthing Center

NO INTERVENTION

The nurses working in the Intervention Birthing Centers did not receive the Simulation Based Mentorship Program.

Interventions

In this program, local level mentors were developed to provide regular mentorship on low-dose high-frequency approach in contrast to one-time coaching in a long gap. This program combined the existing package of the continuum of care along with Helping Babies Survive (HBS) \& Helping Mothers Survive (HMS) guidelines, adopting a simulation-based onsite mentoring and coaching approach. The mentors provided monthly mentorship on following seven modules topics to the nurses of the intervention birthing centers: 1. Infection prevention 2. Antenatal care and counseling 3. Essential care of labor and birth 4. Helping babies breathe 5. Bleeding after birth 6. Essential care of labor and birth 7. Postnatal care and counseling Every monthly session was followed by four weekly practice sessions. The nurses from intervention birthing centers were also called mentees.

Also known as: SBMP
Intervention Group/ Intervention Birthing Center

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nurses working in selected Birthing Centers during the baseline enrollment

You may not qualify if:

  • Newly recruited nurses by the Birthing Centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

One Heart Worldwide

Kathmandu, Bagmati, Nepal

Location

Related Publications (8)

  • Utz B, Siddiqui G, Adegoke A, van den Broek N. Definitions and roles of a skilled birth attendant: a mapping exercise from four South-Asian countries. Acta Obstet Gynecol Scand. 2013 Sep;92(9):1063-9. doi: 10.1111/aogs.12166. Epub 2013 Jun 15.

    PMID: 23656549BACKGROUND
  • Olson KR, Caldwell A, Sihombing M, Guarino AJ, Nelson BD, Petersen R. Assessing self-efficacy of frontline providers to perform newborn resuscitation in a low-resource setting. Resuscitation. 2015 Apr;89:58-63. doi: 10.1016/j.resuscitation.2015.01.008. Epub 2015 Jan 19.

    PMID: 25613363BACKGROUND
  • Alamrani MH, Alammar KA, Alqahtani SS, Salem OA. Comparing the Effects of Simulation-Based and Traditional Teaching Methods on the Critical Thinking Abilities and Self-Confidence of Nursing Students. J Nurs Res. 2018 Jun;26(3):152-157. doi: 10.1097/jnr.0000000000000231.

    PMID: 29016466BACKGROUND
  • Krielen P, Meeuwsen M, Tan ECTH, Schieving JH, Ruijs AJEM, Scherpbier ND. Interprofessional simulation of acute care for nursing and medical students: interprofessional competencies and transfer to the workplace. BMC Med Educ. 2023 Feb 11;23(1):105. doi: 10.1186/s12909-023-04053-2.

    PMID: 36774481BACKGROUND
  • Barre J, Michelet D, Truchot J, Cabon P, Tesniere A. Midwifery students' retention of learning after screen-based simulation training on neonatal resuscitation: a pilot study. BMJ Simul Technol Enhanc Learn. 2020 Apr 6;7(1):31-34. doi: 10.1136/bmjstel-2019-000525. eCollection 2021.

    PMID: 35521074BACKGROUND
  • Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.

    PMID: 27902949BACKGROUND
  • Lee BO, Liang HF, Chu TP, Hung CC. Effects of simulation-based learning on nursing student competences and clinical performance. Nurse Educ Pract. 2019 Nov;41:102646. doi: 10.1016/j.nepr.2019.102646. Epub 2019 Oct 23.

    PMID: 31698255BACKGROUND
  • Hung CC, Kao HS, Liu HC, Liang HF, Chu TP, Lee BO. Effects of simulation-based learning on nursing students' perceived competence, self-efficacy, and learning satisfaction: A repeat measurement method. Nurse Educ Today. 2021 Feb;97:104725. doi: 10.1016/j.nedt.2020.104725. Epub 2020 Dec 16.

    PMID: 33373813BACKGROUND

Study Officials

  • Surya Bhatta, MHCDS

    One Heart Worldwide

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study Birthing Centers were categorized into Intervention Birthing Center and Control Birthing Center
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 16, 2024

Study Start

November 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations