EXPERIMENTAL

STUDY DESIGN
 INTRODUCTION
• An experiment is a study designed to compare benefits of an intervention
with standard treatments, or no treatment, such as a new drug therapy or
prevention program, or to show cause and effect.
• Experimental research designs are concerned with examination of the effect
of independent and dependent variables where independent variable is
manipulate through treatment or intervention and the effect of those
intervention is observed on the dependent variable.
 OBJECTIVE

• To provide a scientific proof

• To provide a measuring method
 PROTOCOL

•One of the essential features of a randomized controlled trial is that the study is
conducted under a strict protocol.
•The protocol specifies:-
•the aims and objectives of the study
•questions to be answered
•criteria for the selection of study and control groups
•size of the sample
•the procedures for allocation of subjects into study and control groups
•treatments to be applied
The protocol also specifies:-
• Standardization of working procedures
• Schedules as well as responsibilities of the parties involved
The protocol aims at
•Preventing bias
•To reduce the source of error in the study
 SELECTING REFERENCE AND
EXPERIMENTAL POPULATION
A) REFERENCE OR TARGET B) EXPERIMENTAL OR STUDY
POPULATION: POPULATION:
• Population to which the findings of • It is derived from the reference
the trial, if found successful, are population. It is the actual population
expected to be applicable. that participates in the experimental
EXAMPLE: study.

• Geographically limited population • Ideally, it should be randomly chosen

of a whole city a population of from the reference population, so that
it has the same characteristics as the
school children industrial workers.
reference population.
 RANDOMIZATION

• Randomization is a statistical
procedure by which the participants are
allocated into groups usually called
"study" and "control" groups, to
receive or not to receive an
experimental preventive or therapeutic
procedure, man oeuvre or intervention.
• Randomization is an attempt to
eliminate "bias" and allow for
comparability.
 CONTINUE:

• The entire study population can be stratified into subgroups according to the
variable, and individuals within each sub-group can then be randomly
allocated into study and control groups.
• Randomization is done only after the participant has entered the study, that is
after having been qualified for the trial and has given his informed consent to
participate in the study.
 FOLLOW UP:
• This implies examination of the experimental and control group subjects at defined
intervals of time, in a standard manner, with equal intensity, under the same given
circumstances, in the same time frame till final assessment of outcome.

• ATTRITION - some losses to follow-up are inevitable due to factors, such as death,
migration and loss of interest.

• Every effort, should be made to minimize the losses to follow-up.

 ASSESSMENT:

• The final step is assessment of the outcome of the trial in terms of :

• (a) Positive results : that is. benefits of the experimental measure such as
reduced incidence or severity of the disease, cost to the health service or other
appropriate outcome in the study and control groups.
• (b) Negative results : that is, severity and frequency of side-effects and
complications, if any, including death. Adverse effects may be missed if they
are not sought.
SUMMARY OF STEPS
 TYPES OF EXPERIMENTAL STUDY
DESIGNS

• True Experimental Design

• Quasi Experimental Design
• Pre-experimental Design
 TRUE EXPERIMENTAL DESIGN

• True experimental research designs are those where

researchers have complete control over the extraneous
variables & can predict confidently that the observed
effect on the dependable variable is only due to the
manipulation of the independent variable.
ESSENTIAL CHARACTERISTICS…

• A true experimental research design must essentially

consist of the following three characteristics:
Manipulation
Control
Randomization
TYPES OF TRUE EXPERIEMNTAL
DESIGN
True Experiential Design

Crossover
Post-test
only

Randomized
Pretest block
post-test
only

Solomon 4 Factorial
groups
 Post-test-only control design:
• Composed of two randomly assigned group, i.e. experimental
& control, but neither of which is pretested before the
implementation of treatment on the experimental group.
• In addition, while treatment is implement on the experimental
group only, post-test observation is carried out on both the
group to assess the effect of manipulation.
• This design can be helpful in situations where it is not possible
to pretest the subjects.
• For example, to study the effect of an educational intervention
related to urinary incontinence on the subsequent help-seeking
behavior of older adults.
 Cont.…

Exp. group Treatment Post-test

Random
assignment

Control group Post-test

 Pretest-post-test-only design

• In this research designs, subjects are randomly assigned to

either the experimental or the control group.
• The effect of the dependent variable on both the groups is seen
before the treatment (pretest).
• Later, the treatment is carried out on experimental group only,
& after-treatment observation of dependant variable is made
on both the groups to examine the effect of the manipulation
of independent variable on dependant variable.
• For example, such a design could be used for ‘an experimental
study to assess the effectiveness of cognitive behavioral
therapy interventions for patients with breast cancer.’
 Cont.…

Post-
Exp. group pretest Treatment
test

Random
assignment

Control
pretest Post-test
group
 Solomon four-group design
• There are two experimental groups (experimental group 1 &
experimental group 2) & two control groups (control group 1
& control group 2).
• Initially, the investigator randomly assigns subjects to the four
groups.
• Out of the four groups, only experimental group 1 & control
group1 receives the pretest, followed by the treatment to the
experimental group 1 & experimental group 2.
• Finally, all the four groups receive post-test, where the effects
of the dependant variables of the study are observed &
comparison is made of the four groups to assess the effect of
independent variable (experimental treatment) on the
dependant variable.
 Count…

• In this, experimental group 2 was observed at one occasion,

& that score should be similar to average scores of those in
experimental & control groups.
• To estimate the amount of change in experimental & control
group 2, the average test scores of experimental & control
groups 1 are used as baseline.
• The solomon four-group design is believed to be most
prestigious experimental research design, because it
minimizes the threat to internal & external validity.
 Cont.…
Exp. Group 1 pretest treatment Post-test

Control Group 1 pretest Post-test

Random
assignment

treatment Post-test
Exp. Group 2

Control Group 2 Post-test

www.drjayeshpatidar.blogspot.com
 Factorial design
• In factorial design, researcher manipulates two or more
independent variables simultaneously to observe their effects on
the dependant variables.
• This design is useful when there are more than two independent
variables, called factors to be tested.
• For example, a researcher wants to observe the effect of two
different protocols of mouth care on prevention of VAP when
performed at different frequencies in a day.
• This design also facilitates the testing of several hypothesis at a
single time.
• The first number (α) refers to the independent variables or the
type of experimental treatments, & the second number (β) refers
to the level or frequency of the treatment.
 Count…
Frequency of Protocols of the mouth care
mouth care Chlorhexidine Saline (α2)
(α1)
4 hourly (β1) α1….β1 α2….β1
6 hourly (β2) α1….β2 α2….β2
8 hourly (β3) α1….β3 α2….β3
 Crossover design
• In this design, subjects are exposed to more than one
treatment, where subjects are randomly assigned to different
orders of treatment.
• It is also known as ‘repeat measures design’.
• This design is more efficient in establishing
the highest
possible similarity among subjects exposed to different
conditions, where groups compared obviously have equal
distribution of characteristics.
• Though, crossover design is considered as an extremely
powerful research design, sometimes it is not effective
because when subjects are exposed to two different conditions,
their responses of the second condition may be influenced by
their experience in the first condition.
 Count…
• For example, when we are comparing the effectiveness of
the chlorhexidine mouth care protocol on group I & saline
mouth care protocol on the subjects of group II.
• Later, the treatment is swapped, where group I receives the
saline mouth care & group II receives chlorhexidine. In such
studies, subjects serve as their own control.
Groups Protocols of the mouth care
Group I Chlorhexidine (α1) Saline (α2)

Group II Saline (α2) Chlorhexidine (α1)

 Randomized block design

• Control of inherent differences between experimental subjects

& differences in experimental conditions is one of the difficult
problems faced by researcher in biological sciences.
• When there are a large number of experimental comparison
groups, the randomized block design is used to bring
uniformity among selected different groups.
• This is simple method to reduce the variability among the
treatment groups by a more homogeneous combination of the
subjects through randomized block design.
 Cont.…

• For example, a researcher wants to

examine the effects of three
different antihypertensive drugs on
patients with hypertension.
• To ensure the homogeneity among
the subjects in treatment, researcher
randomly places the subjects in
homogeneous groups (blocks) like
patients with primary hypertension,
diabetic patients with hypertension,
& renal patients with hypertension .
 Advantages of true experimental design

• Experimental research designs are considered the most powerful

designs to establish the causal relationship between independent
& dependant variables.
• Where the purpose of research is explanation, causal relationship
may be established among the variables by experimentation,
especially in studies involving physical objects, where the
variables are more easily controlled than in human studies.
• In this studies, the controlled environment in which the study is
conducted can yield a greater degree of purity in observation.
 Count…

• Conditions not found in a natural setting can be created in an

experimental setting, where the independent variable is
manipulated by investigator.
• In the experimental approach, we can often create conditions in a
short period of time that may take years to occur naturally. For
example, in genetic studies we can breed strains in very small
time, which would take a long time in nature to occur.
• When the experiment is conducted in a laboratory, experimental
unit, or other specialized research setting, it is removed from the
pressure & problems of real-life situations & the researcher can
pursue his or her studies in a more leisurely, careful, &
concentrated way.
 Disadvantages of true experimental
design
• Most of the times, the results of experimental research designs
cannot be replicated in studies conducted on human beings due
to ethical problems.
• For certain research problems, because of the danger to
physical & psychological health of the human subjects, it is not
possible to conduct experiments on human beings.
• Many of the human variables neither have valid measurable
criteria nor instruments to measure them. For example, patient
welfare or level of wellness cannot be measured on any scale or
by any instrument. In these situations, if a refined experimental
design is used, there may be a mismatch of research design &
the variable-measuring instruments.
 Count…

• In experimental studies conducted in natural settings like

hospitals or community, it is not possible to impose control
over extraneous variables.
• Another disadvantage of the experimental research design
is that it is very difficult to get cooperation from the study
participants, because it may involve medical or surgical
treatment or intervention, which may make the prospective
subjects reluctant to participate in research study.
 QUASI-EXPERIMENTAL STUDY
DESIGN

• Quasi-experimental research design involves the manipulation

of independent variable to observe the effect on dependant
variable, but it lacks at least one of the two characteristics of
the true experimental design; randomization or a control group.
• Quasi-experimental designs are generally used to establish the
causality (effect of independent variable on dependent variable)
in situations where researchers are not able to randomly assign
the subjects to groups or for various reasons no control group is
available for an experimental study.
 Main characteristics…

• Manipulation of the independent variables to observe the

effects on the dependant variables.
• Lack of at least one of the two other essential characteristics
of the true experiment, i.e. random assignment of subject or a
control group.
• Quasi-independent variables are used instead of true
independent variables. Where independent variable is not
manipulates in complete controller situations.
 Types of quasi-experimental design

• Nonrandomized control group design

• Time-series design
 Non-randomized control group
design
• It is also known as the ‘nonequivalent control group design’.
• This design is identical to the pretest-posttest control group
design, except there is no random assignment of subjects in
experimental & control groups.
• In this design, experimental & control groups are selected
without randomization, & dependent variables are observed in
experimental as well as control groups before the intervention.
• Later, the experimental group receives treatment & after that
posttest observation of dependant variables is carried out for
both the groups to assess the effect of treatment on experiment
group.
 Count...

Exp. group Pretest Treatment Post-test

Control group Pretest Post-test

www.drjayeshpatidar.blogspot.com
 Count…

• For example, this method was used to study ‘the effects of integrated
care on quality of work in nursing homes: a quasi-experiment’.
• The purpose of this study was to examine the implementation of
integrated care in the nursing home sector, & its effect on the quality
of work of the caregivers.
• A nonequivalent pretest-posttest control group design was used in
this study.
 Time-series design

• This design is useful when the experimenter wants to measure the

effects of a treatment over a long period of time.
• The experimenter would continue to administer the treatment &
measure the effects a number of times during the course of the
experiment.
• Generally it is a single-subject research, in which the researcher
carries out an experiment on an individual or on a small number of
individuals, by alternating between administering & then
withdrawing the treatment to determine the effectiveness of the
intervention.
Exp.
O1 O2 O3 Treatment O1 O2 O3
group
 Count…

• A researcher might assess pain levels of a group of patients with low-back

pain. After 3 weeks of pain assessment, subjects are taught special exercises
to reduce that pain. During the next 3 weeks, pain levels would again be
measured.
• Measuring a child’s school performance on a weekly basis, & then
introducing a new teaching technique. Then again measuring on a weekly
basis.
Advantages of quasi-experimental design
• Quasi-experimental designs are more frequently used because
they are more practical & feasible to conduct research studies
in nursing, where in the absence of a large sample size,
randomization &/ or availability of control groups are not
always possible.
• This design is more suitable for real-world natural setting than
true experimental research designs.
• It allows researchers to evaluate the impact of quasi-
independent variables under naturally occurring conditions.
• It may be able to establishing casual relationship wherein some
of the hypotheses are practically answered through this design
only.
 Disadvantages of quasi-experimental
design

• There is no control over extraneous variables influencing the dependant

variables.
• The absence of a control group or lack of control over the research setting
makes the results of this design less reliable & weak for the establishment of
casual relationship between independent & dependant variables.
 PRE-EXPERIMENTAL DESIGN

• This research design is considered very weak, because the researcher has very
little control over the experiment.

TYPES OF PRE-EXPERIMENTAL RESEARCH DESIGN:

o One-shot case design
o One-group pretest-posttest design
 One-shot case design

• In this research design, a single experimental group is exposed to a

treatment & observations are made after the implementation of
that treatment.
• There is no random assignment of subjects to the experimental
group & no control group at all.

Exp. group Treatment Post-test

 One-group pretest-posttest design

• It is the simplest type of pre-experimental design, where only

the experimental group is selected as the study subjects.
•A pretest observation of the dependant variables is made
before implementation of the treatment to the selected group,
the treatment is administered, & finally a posttest observation
of dependant variables is carried out to assess the effect of
treatment on the group.
• Some researcher also argue this design as sub type of quasi-
experimental research design. However in absence of both
randomization & control group.
Exp. group Pretest Post-test
ADVANTAGES OF PRE-EXPERIMENTAL DESIGN:
o Very simple & convenient to conduct these studies in natural
settings, especially in nursing.
o Most suitable design for the beginners in the field of experimental
research.

DISADVANTAGES OF PRE-EXPERIMENTAL DESIGN:

o Considered a very weak experimental design to establish casual
relationship between independent & dependant variables, because it
controls no threat to internal validity.
o It has very little control over the research.
o It has a higher threat to internal validity of research, & may have a
selection bias, which can be very serious threats for in using this
particular design.
REFERENCES:
 K. Textbook of Preventive & Social Medicine, 22nd Edition. Jabalpur:
Banarasidas Bhanot Publishers; 2013.

 Peter S. Essentials of Preventive & Community Dentistry, 2 nd Edition. New Delhi:

Arya Publishing House; 2004.
 C.M. Marya, A Textbook of Public Health Dentistry, Jaypee Brothers Medical
Pub; 1 edition, 30 March 2011. 
 S.S. Hiremath, Textbook of preventive and community dentistry, Elsevier; Second
edition, 1 January 2011
 Health Research Methodology – A Guide for training in Research (1992). WHO
 https://cirt.gcu.edu/research/developmentresources/research_ready/
experimental/design_types
 http://accesspharmacy.mhmedical.com/content.aspx?
bookid=438&sectionid=40428525
 www.googleimages.com
 h
a
n
k
Y
www.drjayeshpatidar.blogspot.com
o