Randomized Controlled Superior Trial Study:  On advanced delivery mechanism simulator regarding performance of spontaneous vaginal delivery among B.Sc. Nursing Students.

 

Mrs. Shalini Jose, Mrs. Gauri Manohar

Asst. Professors, Department of Obstetrics and Gynecology,

Bombay Hospital College of Nursing, Ring Road, Indore, M.P

*Corresponding Author Email: shalinijose01@gmail.com, gauri_chincholikar@yahoo.co.in

 

ABSTRACT:

Randomized Controlled Trial study on advanced delivery mechanism simulator with Parallel Group Design was used with 38 randomly selected B.Sc nursing students of Bombay Hospital College of Nursing, Indore. The outcome of interest was pragmatic, and superiority trial was done. Out of 40 eligible participants, 38 participants were enrolled, and 2weeks were taken for pre test assessment. Allocation Concealment was done by the assessor, 38 participants were randomly divided into experimental and control group, also it was a single blind trial. The total study period was decided for 4 weeks. In the 4th week performance assessment was done of experimental and control group students by checklist and results were analyzed . The data analysis was done by using paired, unpaired t test and effect size was done by Cohen’s test, which has found to be larger effect size. The study revealed that advanced delivery mechanism simulator training was better than low cost delivery model in performance of spontaneous vaginal delivery among experimental group and control group, findings were significant at 0.05 level, also it is estimated that advanced delivery mechanism simulator training is better than low cost delivery model in performance of spontaneous vaginal delivery.

 

KEYWORDS: Randomized Controlled Trial, advanced delivery mechanism simulator, low cost delivery model, spontaneous vaginal delivery, performance.


 

 

INTRODUCTION:

Simulation, the art and science of recreating a clinical scenario in an artificial setting, has been an important aspect of nursing program curriculums for decades (Gomez and Gomez, 1987).

 

Insufficient maternal care during pregnancy and delivery is responsible for the staggering more than half a million maternal deaths so roughly three quarters of all maternal deaths occur during delivery and in the immediate post-partum period.

 

Simulation has allowed deliberate practice in a controlled environment because of which students are able to practice a procedure prior to performance on  live patient.

 

PROBLEM STATEMENT:

A randomized controlled superior trial study to determine the effectiveness of advanced delivery mechanism simulator compared with low cost delivery model on performance of spontaneous vaginal delivery among B.Sc. nursing students.

 

OBJECTIVES:

1.        To assess the performance of spontaneous vaginal delivery among B.Sc. nursing students of experimental and control group.

2.        To evaluate the effectiveness of advanced delivery mechanism simulator training in performance of spontaneous vaginal delivery among experimental group.

3.        To evaluate the effectiveness of low cost delivery model training in performance of spontaneous vaginal delivery among control group.

4.        To determine that advanced delivery mechanism simulator is better than low cost delivery model in performance of spontaneous vaginal delivery among experimental group and control group.

 

MATERIALS AND METHODS:

A randomized controlled design with repeated measures of pre- and post treatment design was used to address the aim of this study. The selected research design was RCT Parallel Group Design. The design helped in randomized selection of subjects, which helped to maintain the internal validity.

 

Setting:

The study was conducted at Bombay Hospital College of Nursing, Indore

 

Participants:

The study was conducted on total 40 eligible B.Sc Nursing Students. Out of which 38 were enrolled who were randomly distributed equally into experimental and control group.

 

Intervention:

Experimental group were given advanced delivery mechanism simulator training while control group was given low cost delivery model training. Comparison of performance score was done between the experimental and control group.

 

Performance Tests:

Performance of the students was divided into 3 headings-

 

·          Knowledge- It consist of 3 questionnaire based on stages, cardinal movements and steps of normal vaginal delivery.

·          Skill- It consists of 6 tasks on assessment of fetal station and position, delivery of the fetal head, assess for nuchal cord, delivery of remaining body and placenta.

·          Documentation- It comprises of delivery type and position, Presence or absence of nuchal cord, description of placenta and cord, description of lacerations,

 

Sample collection method:

In the pre-intervention phase the researcher after getting the approval for the research project from the ethical and Research Committee explained the goals of the study to participants.

Out of 40 eligible participants, 38 participants were enrolled, and 2weeks were taken for pre test assessment.

 

Allocation Concealment i.e. concealed future group allocation into experimental and control group was done by the assessor. 38 participants were randomly divided into experimental and control group by randomization using lottery method and assessor was not aware about the division of groups as well as the intervention to be given.

 

The number of participant in experimental group is 18 and in control group is 17.

 

It was a single –blind trial i.e. trainers and participants know the intervention but the assessor was unaware of it during the post randomization phase.

 

Experimental Group:

The total study period was decided for 4 weeks. For the first 1-week participants were given advanced delivery mechanism simulator training, for continuous 4 days, one hour fifteen minutes daily (15mts each student), in which 1 student was absent. For the 2-week the participants were asked to perform spontaneous vaginal delivery by advanced delivery mechanism simulator under supervision. For the 3-week the participants were asked to perform spontaneous vaginal delivery by advanced delivery mechanism simulator without supervision. In the 4-week performance assessment was done of 18 students by checklist and results were analyzed.

 

Control Group:

For the first 1-week participants were given low cost delivery model training, for continuous 4 days, one hour fifteen minutes daily (15mts each student), in which 1 student was absent and 1 was sick. For the 2-week the participants were asked to perform spontaneous vaginal delivery by low cost delivery model under supervision. For the 3-week the participants were asked to perform spontaneous vaginal delivery by low cost delivery model without supervision. In the 4-week performance assessment was done of 17 students by checklist and results were analyzed.

 

RESULTS:

I. Demographic Variables:

The results obtained in the present study showed that subjects mean age in the experimental and control group were 21.5 and 22 years respectively. 37% of the participants willingly joined nursing and 56% joined on the wish of their parents and 7 % were not interested in nursing. 40% and 55 % of experimental and control group participants father were working in private firm. 42% and 36% of experimental and control group participants father have completed their education up to graduation. 44 % and 30% of experimental and control group mother of participants were working.

 

II. Testing the H1 Hypothesis- (2-tailed): There will be significant difference between pre and post test score of experimental  group

Groups

Pre-Intervention

Post-Intervention

Paired
t value

 

Level of Significant 0.05%

Pre test
Mean

 

Std. Deviation

Post test
Mean

Std. Deviation

Experi

mental Group

10

2.08

20.7

5.6

7.98

S*

* Significant

 

The calculated “t” value is 7.98 which is greater than tabulated value at 0.05 level of significance which shows that result is significant the H1 hypothesis is accepted.

 

III. Testing the H2 Hypothesis-(2-tailed): There will be significant difference between pre and post test score of control  group

Groups

Pre-Intervention

Post-Intervention

Paired
t value

 

Level of Significant 0.05%

Pre test
Mean

 

Std. Deviation

Post test
Mean

Std. Deviation

Control Group

9.2

1.78

9.5

3.5

0.31

NS

NS- Not Significant

 

The calculated “t” value is 0.31 which is lesser than tabulated value at 0.05 level of significance so the H2 hypothesis rejected and null hypothesis H0 is accepted.

H0- There will be no significant difference between pre and posttest performance scores of control group.

 

IV. Testing the H3 Hypothesis- (1-tailed): Mean post test performance score of experimental group who underwent advanced delivery mechanism simulator training will be significantly higher than the mean post test performance score of control group who underwent low cost delivery model training.

Groups

Post-Intervention

Unpaired
t value

Level of Significant 0.05%

Post Intervention
Mean

Std. Deviation

Experimental Group

20.7

5.6

7.33

S*

Control Group

9.5

3.5

* S= Significant

 

The calculated “t” value is 7.33 which is greater than tabulated value at 0.05 level of significance. It shows that the result is significant and H3 hypothesis is accepted. The effect size of advanced delivery mechanism simulator training compared with low cost delivery model training was done by Cohen’s test and the result is d=2 (larger effect), which state that average person in the experimental group would score higher than 98% of a control group.

 

DISCUSSION:

On the basis of results it could be concluded that, there is a significant difference between post test mean performance score of advanced delivery mechanism simulator training when compared with low cost delivery model training and demonstrated significant improvements in the technical skills in performing spontaneous vaginal delivery with help of advanced delivery mechanism simulator training.. Also it is estimated that advanced delivery mechanism simulator training is better than low cost delivery model in performance of spontaneous vaginal delivery among experimental group and control group. The concept of the increased level of sophistication and realism in laboratory setting, has elicited the possibility of simulation being used as a substitute for actual clinical experience.

 

REFERENCES:

1.       Frank D. Hicks et.al, the effect of high fidelity simulation on nursing students knowledge and performance: Pilot Study, NCSBN Research, June2009, Vol40

2.       Norico F. et al, Antenatal care in the capital city of Cambodia – current situation and impact on obstetric outcome. Journal of Gynecological research 2005;Vol 3(28): 133-38

3.       Christoph Scholz et.al, high fidelity simulation increases obstetric self assurance and skills in undergraduate medical students, J Perinat Med. 2012 Nov; Vol 40(6):607-13.

4.       Sok Ying Liaw et.al, Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial, Journal of Medical Internet Research, 2014 Sep 17, Vol 16(9)

5.       DeStephano CC et.al, A randomized controlled trial of birth simulation for medical students, Am J Obstet Gynecol.2015 July, Vol 213(1):91

6.       Fransen A et.al, Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial. BJOG.2012; Vol 119 Issue 11, 13871393.

 

 

 

 

Received on 24.02.2017          Modified on 258.03.2017

Accepted on 20.06.2017         © A&V Publications all right reserved

Int. J. Nur. Edu. and Research. 2017; 5(3): 229-231.

DOI:  10.5958/2454-2660.2017.00049.7