TITLE OF THE STUDY
Randomized
Controlled Trial On Effectiveness Of NurseLed Multifactorial Intervention Program NLMIP On
Psychological Problems And WellBeing Among Elderly Residing In Selected
Assisted Senior Living Facilities
OBJECTIVES
To assess the pre-test psychological problems (stress, anxiety, and
depression), well-being (physical, mental, social, emotional, and spiritual),
and quality of life among the elderly in experimental and control groups.
To evaluate the effectiveness of the Nurse-Led Multifactorial
Intervention Programme (NLMIP) on psychological problems, well-being, and
quality of life among the elderly in the experimental group.
To find out the correlation between psychological problems, well-being,
and quality of life among the elderly in the experimental group.
To compare the post-test scores of psychological problems and well-being
and quality of life among the experimental group and control group.
To find an association between the pre-test scores of psychological
problems, well-being, and quality of life among the elderly with the selected
demographic variables problems in the experimental and control groups.
HYPOTHESES: All hypotheses
will be tested at a 0.05 level of significance.
H01: The mean
post-test stress scores will be significantly lesser than the mean pre-test
scores stress scores among the elderly in the experimental group.
H02: The mean
post-test anxiety scores will be significantly lesser than the mean pre-test
anxiety scores among the elderly in the experimental group.
H03: The mean post-test depression scores will be
significantly lesser than the mean pre-test depression scores among the elderly
in the experimental group.
H04: The mean
post-test well-being scores will be significantly higher than the mean pre-test
well-being scores among elderly with psychological problems in the experimental
group.
H05: The mean
post-test quality of life scores will be significantly higher than the mean
pre-test quality of life among the elderly with psychological problems in the experimental
group.
H06: There will be a significant
correlation between stress, anxiety, depression, and well-being among the elderly
with psychological problems in the experimental group.
H07: There will be a
significant association between the pre-test scores of psychological problems
and well-being among the elderly with the selected demographic variables
problems in the experimental and control groups.
ASSUMPTIONS
& DELIMITATIONS
Assumptions
Old age is the
most vulnerable period in which the elderly suffer from psychological problems
such as stress, anxiety, and depression.
The level of
stress, anxiety, depression, and well-being among the elderly may vary.
Nurse-led
multifactorial Intervention Programme (NLMIP) helps the elderly manage
psychological problems and improve their well-being.
Delimitations:
The
study will be delimited to:
The study is only
done on the elderly people residing in selected senior
assisted living facilities in Dehradun.
Study participants
are limited to those aged 60 to 75 years.
The NLMIP is limited to 2 weeks duration, for 1 hour.
RESEARCH
METHODOLOGY
Research
approach: Quantitative
approach.
Trial design
including allocation ratio with schematic representation
Research design: Randomized Control Trial – Pre-test, Post-test control
group design (repeated measure design). The participants will be randomized
into either the experimental or control arm through block randomization.
Randomization
sequence generation: Permuted
block randomization shall be used to allocate the samples into two groups.
Allocation
concealment mechanism: Allocation concealment mechanism is the technique of
ensuring that implementation of the random allocation sequence occurs without
knowledge of which participants and the researcher. The sequentially numbered,
opaque, sealed envelopes (SNOSE) technique will be the allocation concealment
technique used in this study.
Blinding:
Considering
the nature of the study blinding is not applicable.
Research
Settings: The
settings of the study will be selected senior assisted living facility at
Dehradun, Uttarakhand.
Sample
Elderly
residing in selected senior assisted living facilities, Dehradun, Uttarakhand,
who fulfilled the inclusion criteria.
Sampling
technique: Non-probability
purposive sampling technique was used to select
the samples for the study.
Sample
size: The
total sample size of the study would be 120.
Participant’s
eligibility criteria- Inclusion and exclusion criteria
Inclusion criteria
Elderly people living in the assisted living homes of
Dehradun.
Elderly between the age group of 60 to 75 years.
Elderly people with mild to moderate levels of stress,
anxiety, depression, and low well-being.
Elderly who are willing to attend sessions of Nurse-Led
Multifactorial Intervention Programme.
Elderly who can
speak and understand Hindi/English.
Exclusion Criteria
Elderly people who have severe depression and neurological disorders.
Elderly people who refuse to engage in the study.
Elderly who are
not available during data collection.
Description
of the tool: The
data collection tool consists of sections A, B, C, and D
1. Section
A:
Tool 1: Demographic information and characteristics of the elderly shall
be collected using separate data sheets. It consists of 19 items on personal
data of elderly residents, such as age, gender, religion, residence, educational
status, employment status, monthly income, source of monthly income, previous
occupation, socioeconomic status, marital status, no of children, support
system, Reason for staying at Senior
assisted living facility, Duration of Stay in Senior assisted living facility,
Type of Senior assisted living facility, Perceived health status, History of
chronic illnesses, substance abuse.
2.
Section B: Tools for
measurement of psychological problems –
Tool 2 - Perceived Stress Scale
Tool 3: Generalized Anxiety Disorder Assessment
Tool 4: Brink et al geriatric depression scale Section – C: Tool
for measurement of well-being
3.
Section – C: Tool 5: Ryff’s 42-item
version of psychological well-being scales (PWB)
4.
Section – D: Tool 6: For measurement of Quality of Life (WHO QOL – BREF 26).
INTERVENTION:
Nurse-Led Multifactorial Intervention Programme :
Relaxation techniques - Jacobson Progressive Muscle Relaxation Techniques
Recreational
therapy - Play therapy,
Counselling:
Life review
Psychoeducation
INTERVENTION
SCHEDULE
Plan
for Data Collection
The permission for
the data collection will be obtained from selected assisted living facilities in
Dehradun, Uttarakhand
Informed consent
will be obtained from all the participants.
Allocation of the
participants to experimental and control groups by randomization
Plan
for Data Collection
The permission for
the data collection will be obtained from selected assisted living facilities in
Dehradun, Uttarakhand
Informed consent
will be obtained from all the participants.
Allocation of the
participants to experimental and control groups by randomization
Assess the stress,
anxiety, depression, and well-being among elderly between 60 to 75 years
Administration of a
Nurse-Led Multifactorial Intervention Programme for 14 days, lasting for 1 hour
(2 weeks)
Post-test will be
conducted in the following days using the same tools,
The 1st
post-test will be collected after 1 month of intervention
The 2nd
post-test will be collected after 2 months of intervention.
The 3rd
post-test will be collected after 3 months of intervention.
Reinforcement
therapy:
This will be provided after 45 days, through making a daily diary.
Outcome
The primary
outcome
of the study is to decrease the level of psychological problems and improve the
well-being of the elderly.
The secondary
outcome will
be to improve the quality of life.
Plan
for data analysis
Descriptive
statistics,
frequency percentage, mean, mean percentage, and standard deviation will be
used to describe demographic variables and the pre and post-test scores of
stress, anxiety, depression, and well-being
Inferential
statistics Chi-square
test shall be used to find the association of psychological problems and well-being
with selected socio-demographic characteristics of the elderly. The correlation
between psychological problems and well-being will be estimated using the Karl
Pearson Formula. Repeated measures of ANOVA to determine the significance of
the difference between the mean pre-test scores of stress, anxiety, depression, and well-being and post-scores 1,
2, and 3.
CTRI
Registration the city. The registration in the Clinical Trial Registry -
India will be done immediately after the ethical approval.
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