“A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE
EFFECTIVENESS OF SELECTED MULTICOMPONENT NURSING INTERVENTIONS ON QUALITY OF
LIFE AND BIRTH OUTCOMES OF PREGNANT WOMEN AT MATERNITY HOSPITALS, JODHPUR
(RAJASTHAN)â€.
Background of the study
Pregnancy
is a physiological event, and it creates an important burden and stress for the
female body. The expectant mother experiences many anatomical, physiological,
psychological and biochemical changes to meet developing fetal demands, to
protect homeostasis, to prepare for birth and lactation. These changes can
affect the quality of life (QOL) of pregnant women, affecting both maternal and
infant health. Maternal stress may increase the level of corticotrophin
releasing hormone (CRH) in pregnancy that might lead to premature delivery.
This may in-turn prove fatal and result in harming the child itself 3.
According
to SRS 2016-18 MMR of India is 113 and in Rajasthan MMR is 164. In 2018, Peri-natal mortality rate of India was 22 and in
Rajasthan it was 26. In India neonatal mortality rate is 23 and early
neonatal mortality rate is 18. Neonatal mortality rate is 26 and early neonatal
mortality rate is 20 in Rajasthan 4.
AIM AND OBJECTIVES
AIM:
This study aims to evaluate the effectiveness of
selected multicomponent nursing interventions on quality of life and birth
outcomes of pregnant women at maternity hospitals, Jodhpur (Rajasthan).
PRIMARY OBJECTIVE:
1. To assess and compare quality of life score
after 10 weeks of follow-up in experimental and control group.
SECONDARY OBJECTIVES:
1. To find out association of quality of life
score with birth outcomes (birth weight, duration of pregnancy, mode of
delivery and APGAR score) in experimental and control group.
2 To
assess quality of life score of pregnant women (21-24 weeks of gestation) at
recruitment and find out its association with demographic variables (age,
habitat, qualification, marital status, type of family, occupation, family monthly
income, dietary pattern, substance abuse, gravida status and biological
variable).
MATERIALS AND METHODOLOGY
PLACE OF STUDY:
The
study will be conducted at Maternity hospitals (Umaid Hospital and MDM
Hospital), Jodhpur (Rajasthan)
STUDY POPULATION/ SAMPLE:
Pregnant
women attending antenatal OPD in II trimester (21-24 weeks of gestation) at
selected maternity hospitals, Jodhpur (Rajasthan) will be taken up for the
study after obtaining a written informed consent.
RESEARCH APPROACH:
Quantitative
experimental research approach will be used.
STUDY DESIGN:
Open
label Randomized Controlled Trial will be used for the study.
PERIOD OF STUDY:
The
study will start after the permission from IEC and will take approximately
12-14 months. Another two months will be required for analysis of data and
writing the thesis.
SAMPLE SELECTION CRITERIA:
Inclusion
Criteria:
• Pregnant women who will be
attending antenatal OPD in II trimester (21-24 weeks of gestation) at maternity
hospitals, Jodhpur.
• Pregnant women between the age
of 18 - 40 years.
• Pregnant women of primi or
secundigravida status.
• Pregnant women who will be
able to read, write and understand Hindi or English or local language.
• Pregnant women who will be
willing to participate in the research study.
Exclusion
Criteria:
· Pregnant women who will be
having high-risk pregnancy.
• Pregnant women with
psychiatric illness such as severe stress and anxiety, mental retardation,
depression, personality disorders etc.
• Premature delivery prior to
completion of the follow-up period.
Variables under study-
• Dependent
variable: Quality of life of Pregnant women and birth outcomes
(birth weight, duration of pregnancy, mode of delivery and APGAR score)
• Independent variable:
Multicomponent Nursing Interventions
• Attribute
variable: Age in years, habitat, qualification, marital status, type of family,
occupation, family monthly income, dietary pattern, substance abuse, gravida
status, and biological variable.
Tool for data collection
• The tool comprises of
three parts: -
Part-I: Socio-demographic proforma and biological variable
Age in years, habitat,
qualification, marital status, type of family, occupation, family monthly
income, dietary pattern, substance abuse, gravida status, and biological
variable (height of the pregnant woman, weight, Hb% and BMI)
Part-II: Quality of life scale standardized tool RAND 36- Item short Form
Survey (SF-36)
Part-III: Birth outcomes: it will be collected after delivery of the newborn.
• Newborn
birth weight
• Duration
of pregnancy
• Mode
of delivery
• APGAR
Score of newborn at 5 minutes after birth
Intervention of the study
- Multicomponent nursing
interventions include: -
- Psychoeducation
(Nutrition, activities of daily living, danger signals during pregnancy
& labour, body image & appearance, self-esteem, personal belief
and thinking, emotional aspect, domestic and sexual violence, engagement
in social events & activities, substance abuse, recreational
activities, arrangements of facilities and various programmes run by
government)
- Antenatal exercises
(walking, pelvic floor exercise, ankle exercise, breathing
exercise)
- Relaxation techniques
(Jacobson progressive muscle relaxation technique)
Data collection procedure
The study will be conducted in
4 phases: -
- Pre-test on quality of life after taking informed
consent (21-24 weeks of gestation)
- Sociodemographic variables
- RAND 36- Item Short Form Survey (SF-36)
II. Application
of selected multicomponent nursing interventions to experimental group.
III. Post-test
assessment of quality of life (31-34 weeks of gestation)
A. RAND 36- Item
Short Form Survey (SF-36)
IV. Assessment
of birth outcomes (after delivery of the newborn)
A. Birth
outcomes
|