Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries

• Sponsor: Heinrich Husslein (Other)
• Overall Status: Completed
• CT.gov ID: NCT03111498
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Training is very important for acquisition and maintenance of obstetric skills. As a one-to-one practical teaching needs time and personal resources, the investigators want to prove the benefit and necessity of the one-to-one training program compared to a theory-based training program in conducting vacuum assisted deliveries (VAD).

The aim of this study is to prove that a practice-based training program (one-to- one teaching) leads to better training results compared to a theory-based training program in conducting VAD.

Condition or Disease	Intervention/Treatment	Phase
Training VAD	Other: practice-based training programme (one-to-one teaching); Other: theory-based training programme	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: video-recorded vacuum procedure on a special VAD-training phantom in a randomized setting: (1) theory-based training programme (2) practice-based training programme (one-to-one teaching). Video-recorded vacuum procedure on the VAD- training phantom before randomization, directly after training programme, 4-8 weeks after training programme in order to determine retention of skills.video-recorded vacuum procedure on a special VAD-training phantom in a randomized setting: (1) theory-based training programme (2) practice-based training programme (one-to-one teaching). Video-recorded vacuum procedure on the VAD- training phantom before randomization, directly after training programme, 4-8 weeks after training programme in order to determine retention of skills.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries - a Randomized Controlled Trial
• Actual Study Start Date: Mar 9, 2017
• Actual Primary Completion Date: Feb 13, 2020
• Actual Study Completion Date: Feb 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: theory-based training programme theory-based training programme (oral presentation including a step-by-step guidance saying)	Other: theory-based training programme; theory-based training programme for conducting VAD
Other: practice-based training practice-based training programme (one-to-one teaching)	Other: practice-based training programme (one-to-one teaching); practice-based training programme (one-to-one teaching) for conducting VAD

Outcome Measures

Primary Outcome Measures

1. technical skills in conducting VAD [one day (day 0)]

   General and procedure-specific skills will be assessed using a validated rating tool.

Secondary Outcome Measures

1. Retention of skills conducting VAD [4-8 weeks after day 0]

   General and procedure-specific skills will be assessed using a validated rating tool.

2. trainees' satisfaction [4-8 weeks after day 0]

   trainees' satisfaction with the two different training programmes will be assessed using a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• employees of the Department of Obstetrics and Gynaecology

• oral and written informed consent

Exclusion Criteria:

• no oral and written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. Obstetrics and Gynaecology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Heinrich Husslein

Investigators

• Study Chair: Julian Marschalek, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heinrich Husslein, Ass-Prof., MD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT03111498
• Other Study ID Numbers: 2300/2016
• First Posted: Apr 12, 2017
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heinrich Husslein, Ass-Prof., MD, Medical University of Vienna: Vacuum assisted delivery; technical skills; training

Study Results

No Results Posted as of Feb 23, 2021